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Top FDA product codes by velocity ratio (last 365d clearance rate ÷ last 1825d baseline rate). A ratio of 2.0× means the code is filing at twice its long-run pace right now. These are the codes the industry's R&D and capital are concentrating in.
| Rank | Code | Device | Specialty | Class | Velocity | Recent (1y) | Baseline (5y) | Recent sponsors |
|---|---|---|---|---|---|---|---|---|
| 1 | — | — | — | — | 3.75× | 9 | 12 | 9 |
| 2 | QSM | System, Surgical, Computer Controlled Instrument, Remanufactured | Gastroenterology, Urology | II | 3.13× | 5 | 8 | 2 |
| 3 | LYC | Bone Grafting Material, Synthetic | Dental | II | 3.13× | 5 | 8 | 4 |
| 4 | LOL | Hepatitis A Test (Antibody And Igm Antibody) | Microbiology | II | 3.0× | 3 | 5 | 2 |
| 5 | SCA | Multi-Analyte Respiratory Virus Antigen Detection Test | Microbiology | II | 2.92× | 7 | 12 | 5 |
| 6 | KRH | Ring, Annuloplasty | Cardiovascular | II | 2.78× | 5 | 9 | 3 |
| 7 | GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | II | 2.73× | 6 | 11 | 4 |
| 8 | DXT | Injector And Syringe, Angiographic | Cardiovascular | II | 2.69× | 7 | 13 | 6 |
| 9 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | Neurology | II | 2.5× | 6 | 12 | 6 |
| 10 | OLI | Fat Reducing Low Level Laser | General, Plastic Surgery | II | 2.5× | 5 | 10 | 4 |
| 11 | SAN | Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples | Microbiology | II | 2.5× | 4 | 8 | 4 |
| 12 | DHB | System, Test, Radioallergosorbent (Rast) Immunological | Immunology | II | 2.5× | 4 | 8 | 1 |
| 13 | MNS | Ventilator, Continuous, Non-Life-Supporting | Anesthesiology | II | 2.5× | 3 | 6 | 3 |
| 14 | MVL | Cord, Retraction | Unknown | — | 2.5× | 3 | 6 | 3 |
| 15 | DSB | Plethysmograph, Impedance | Cardiovascular | II | 2.5× | 3 | 6 | 3 |
FDA product codes ranked by the number of sponsors who filed their FIRST 510(k) in that code during the last 365 days. High first-timer counts = new capital + new R&D entering the category. This is the leading edge of where the focus is going (lags the underlying R&D investment by ~12-24 months).
| Rank | Code | Device | Specialty | First-time filers | Sample firms |
|---|---|---|---|---|---|
| 1 | QIH | Automated Radiological Image Processing Software | Radiology | 39 | Agada Medical, Ltd.Ai4medimaging Medical Solutions S.A.Airs Medical, Inc.Angiowave Imaging, Inc.Anumana, Inc. |
| 2 | LLZ | System, Image Processing, Radiological | Radiology | 34 | AS Software, LLCAgfa Healthcare N.V.Apryse Software CorpArchy Dental, Inc.Artiness S.R.L |
| 3 | GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 29 | Baoding Te'Anzhou Electronic Technology Co., Ltd.Beijing HuaCheng Taike Technology Co., Ltd.Beijing Superlaser Technology Co., Ltd.Bellamia Technologies, Inc.Boston Aesthetics, Inc. |
| 4 | ITI | Wheelchair, Powered | Physical Medicine | 23 | Beijing OrionStar Technology Co., Ltd.Hebei Dansong Medical Technology Co., Ltd.Jiangsu Intco Medical Products Co., Ltd.Jiangsu Yveelt Medical Equipment Co., Ltd.Nanjing CareMoving Rehabilitation Equipment Co.,Ltd |
| 5 | OHS | Light Based Over The Counter Wrinkle Reduction | General, Plastic Surgery | 22 | Atop Lighting Co., Ltd.Dongguan Yanxi Technology Co., Ltd.Dongguan Yijiaming Technology Co., Ltd.Guangdong Ace-Tec Co., Ltd.Heat IN A Click, LLC |
| 6 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 20 | Acotec Scientific Co., Ltd.Ascblue CorporationAsterasys Co., Ltd.Atraverse Medical, Inc.Aventix Medical, Inc. |
| 7 | GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 18 | Ab Medica SasFloShield, Inc.Freyja Healthcare, LLCHangzhou Hawk Optical Electronic Instruments Co., Ltd.Hangzhou Viction Medical Technology Co.,Ltd |
| 8 | INI | Vehicle, Motorized 3-Wheeled | Physical Medicine | 14 | Dongguan Smarfody Mobility Technology Co., Ltd.Jiangsu Bangbang Intelligent Technology Co., Ltd.Jiangsu Intco Medical Products Co., Ltd.Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd.Nanjing Kangni Smart Technology Co., Ltd. |
| 9 | LRK | Device, Anti-Snoring | Dental | 14 | Aiomega, LLCAirway Technologies D/B/A Airway ManagementDcstar, Inc.Dongguan Yiyao Science & Technology Development Co., Ltd.Endeavor Commerce, LLC |
| 10 | ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | 14 | C.A. Medical, LLCDegen MedicalEffortmed, LLCHC Biologics, LLCIntelivation Technologies |
| 11 | DYB | Introducer, Catheter | Cardiovascular | 13 | Cardiocycle Medical(Suzhou) Co., Ltd.Cultiv8 1, LLCEcho Medical, LLCHartman Medical Group, LLCHealth Line International Corporation |
| 12 | DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | 12 | 80 Beats Medical GmbHBeijing Hanvon Health Technology Co., Ltd.Biozen, LLCCardio Ring Technologies, Inc. Taiwan BranchDongguan E-Test Technology Co., Ltd. |
| 13 | NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | 12 | Allumin8, Inc.Beijing Fule Science & Technology Development Co., Ltd.Box Spine, LLCChanpin Medtak Co., Ltd.Double Medical Technology, Inc. |
| 14 | NUC | Lubricant, Personal | Obstetrics/Gynecology | 12 | Ansella TherapeuticsGlobal Protection Corp.Golden Isles Medical, Inc.Guangzhou Haoyimai Trading Co., Ltd.Hudi Pharma Srl |
| 15 | OLO | Orthopedic Stereotaxic Instrument | Neurology | 11 | Balmoral Medical, LLCEvolution SpineFoundation Surgical Group, Inc.K2m, Inc.Orthofix US, LLC |
Recent filings by the top-50 sponsors (by lifetime US 510(k) volume) in the last 90 days. REINFORCE = filed in a code they already own (label expansion, supplement, follow-on = moat-protection move). EXPAND = filed in a code where they had NO prior presence (strategic territory move). Ratio of reinforce vs. expand tells you whether the incumbents are playing defense or going on offense.
| Date | Firm | Move | Code | Class | Specialty | Device |
|---|---|---|---|---|---|---|
| 2026-07-10 | Boston Scientific Corporation | reinforce | ESW | II | General, Plastic Surgery | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) |
| 2026-07-10 | Varian Medical Systems | QKB | II | Radiology | AI Contouring (VA10A) | |
| 2026-07-10 | Masimo Corporation | reinforce | OLW | II | Neurology | SedLine Sedation Monitor |
| 2026-07-10 | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | reinforce | LPH | II | Orthopedic | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; |
| 2026-07-09 | Smith & Nephew, Inc. | reinforce | MBI | II | Orthopedic | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and o |
| 2026-07-08 | Varian Medical Systems, Inc. | reinforce | MUJ | II | Radiology | Virtual Cone (1.0) |
| 2026-07-08 | bioMerieux, Inc. | SAN | II | Microbiology | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | |
| 2026-07-08 | Roche Molecular Systems, Inc. | reinforce | QEP | II | Microbiology | cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG f |
| 2026-07-06 | Smith & Nephew, Inc. | SIQ | II | Orthopedic | TESSA Spatial Surgery System; INTELLIO Tablet (72205455) | |
| 2026-07-01 | Covidien, LLC | reinforce | GAG | II | General Hospital | Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); T |
| 2026-07-01 | SeaSpine Orthopedics Corporation | reinforce | MAX | II | Orthopedic | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray |
| 2026-06-29 | Stryker GmbH | reinforce | HSB | II | Orthopedic | Pangea Femur Reconstruction System |
| 2026-06-29 | Philips Ultrasound, LLC | reinforce | IYN | II | Radiology | Alturion Series Diagnostic Ultrasound System |
| 2026-06-26 | Arthrex, Inc. | reinforce | MBI | II | Orthopedic | Arthrex FiberButton |
| 2026-06-26 | Edwards Lifesciences | PZX | II | General, Plastic Surgery | ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Lef | |
| 2026-06-25 | Siemens Medical Solutions USA, Inc. | reinforce | QIH | II | Radiology | syngo.CT Coronary Cockpit |
| 2026-06-25 | Arthrex, Inc. | reinforce | HWC | II | Orthopedic | Arthrex Sterile VAL and VAL KreuLock Compression Screw System |
| 2026-06-25 | Alphatec Spine, Inc. | SIN | II | Orthopedic | IntraOp Alignment System; CONTOUR3D Bending System | |
| 2026-06-24 | STERIS Corporation | reinforce | FLE | II | General Hospital | AMSCO 700 Steam Sterilizer |
| 2026-06-24 | Medtronic, Inc. | reinforce | KRD | II | Cardiovascular | Concerto Versa Detachable Coil |
| 2026-06-24 | Ge Medical Systems, LLC | reinforce | JAK | II | Radiology | Enhanced Boundary for PCCT |
| 2026-06-22 | Medline Industries, LP | DXQ | II | Cardiovascular | Medline Reusable Blood Pressure Cuff | |
| 2026-06-18 | Siemens Medical Solutions USA, Inc. | reinforce | MUE | II | Radiology | MAMMOMAT B.brilliant (11372950) |
| 2026-06-17 | Boston Scientific Corporation | reinforce | ODG | II | Gastroenterology, Urology | RIVOS EUS Access Device (M00553900) |
| 2026-06-17 | Abbott Medical | reinforce | DQY | II | Cardiovascular | Amplatzer TorqVue Exchange System |
FDA product codes where clearance velocity is FAR below long-run baseline. Two interpretations: (a) the category is dying / commoditized → vacated white space someone could re-enter cheaply, OR (b) the use case is being replaced by a different technology (e.g., glucose meters declining as CGM eats their share). Either way, useful intelligence.
| Rank | Code | Device | Specialty | Velocity | Recent (1y) | Baseline (5y) |
|---|---|---|---|---|---|---|
| 1 | JDR | Staple, Fixation, Bone | Orthopedic | 0.0× | 0 | 21 |
| 2 | LYY | Latex Patient Examination Glove | General Hospital | 0.0× | 0 | 25 |
| 3 | FYC | Gown, Isolation, Surgical | General, Plastic Surgery | 0.0× | 0 | 20 |
| 4 | FLL | Continuous Measurement Thermometer | General Hospital | 0.13× | 2 | 78 |
| 5 | NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | 0.16× | 1 | 32 |
| 6 | KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | 0.18× | 1 | 28 |
| 7 | LZA | Polymer Patient Examination Glove | General Hospital | 0.19× | 14 | 364 |
| 8 | LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | Clinical Chemistry | 0.2× | 1 | 25 |
| 9 | FXX | Mask, Surgical | General, Plastic Surgery | 0.2× | 9 | 226 |
| 10 | MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | Radiology | 0.22× | 3 | 68 |
| 11 | MCW | Catheter, Peripheral, Atherectomy | Cardiovascular | 0.23× | 1 | 22 |
| 12 | LFL | Instrument, Ultrasonic Surgical | Unknown | 0.23× | 1 | 22 |
| 13 | JOJ | Indicator, Physical/Chemical Sterilization Process | General Hospital | 0.31× | 2 | 32 |
| 14 | KGO | Surgeon'S Gloves | General, Plastic Surgery | 0.32× | 2 | 31 |
| 15 | FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | General, Plastic Surgery | 0.37× | 4 | 54 |
Firms across all US medtech that recently tripped the distress signal: small US-cleared portfolio (≤8 clearances), Class I recall in window, dormant ≥730 days. Potential M&A targets via Hilco / Ocean Tomo / Heritage Global outreach.
Filtered view of the same window, restricted to None FDA codes in the All Medtech code list. Shown because you ran the brief with --lane all. The market-analysis sections above are still the primary view; this is supplementary.
Leading-edge items from live external feeds; the warehouse sections above are the lagging FDA record (clearances reflect ~12-18 months of prior R&D + regulatory work).
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