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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 | — | — | — | — | 3.85× | 10 | 13 | 10 |
| 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 | DHB | System, Test, Radioallergosorbent (Rast) Immunological | Immunology | II | 3.0× | 6 | 10 | 1 |
| 5 | FMZ | Incubator, Neonatal | General Hospital | II | 3.0× | 3 | 5 | 2 |
| 6 | SCR | Air-Conduction Hearing Aid Software | Ear, Nose, Throat | II | 3.0× | 3 | 5 | 3 |
| 7 | LOL | Hepatitis A Test (Antibody And Igm Antibody) | Microbiology | II | 3.0× | 3 | 5 | 2 |
| 8 | SCA | Multi-Analyte Respiratory Virus Antigen Detection Test | Microbiology | II | 2.92× | 7 | 12 | 5 |
| 9 | KRH | Ring, Annuloplasty | Cardiovascular | II | 2.78× | 5 | 9 | 3 |
| 10 | GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | II | 2.73× | 6 | 11 | 4 |
| 11 | DXT | Injector And Syringe, Angiographic | Cardiovascular | II | 2.69× | 7 | 13 | 6 |
| 12 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | Neurology | II | 2.5× | 6 | 12 | 6 |
| 13 | OLR | Oral Wound Dressing | Unknown | — | 2.5× | 5 | 10 | 5 |
| 14 | OLI | Fat Reducing Low Level Laser | General, Plastic Surgery | II | 2.5× | 5 | 10 | 4 |
| 15 | GXP | Methyl Methacrylate For Cranioplasty | Neurology | II | 2.5× | 4 | 8 | 2 |
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 | 35 | AS Software, LLCAgfa Healthcare N.V.Apryse Software CorpArchy Dental, Inc.Artiness S.R.L |
| 3 | GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 27 | 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 | 21 | Atop Lighting Co., Ltd.Dongguan Miqiang Technology Co., Ltd.Dongguan Yanxi Technology Co., Ltd.Dongguan Yijiaming Technology Co., Ltd.Guangdong Ace-Tec Co., Ltd. |
| 6 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 19 | Acotec Scientific Co., Ltd.Ascblue CorporationAsterasys Co., Ltd.Aventix Medical, Inc.Baylis Medical Technologies, Inc. |
| 7 | GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 18 | Ab Medica SasFloShield, Inc.Freyja Healthcare, LLCHangzhou Hawk Optical Electronic Instruments Co., Ltd.Integrated Endoscopy, Inc. |
| 8 | INI | Vehicle, Motorized 3-Wheeled | Physical Medicine | 15 | Dongguan Smarfody Mobility Technology Co., Ltd.Jiangsu Bangbang Intelligent Technology Co., Ltd.Jiangsu Intco Medical Products Co., Ltd.Jochu Technology Co., Ltd.Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. |
| 9 | ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | 15 | C.A. Medical, LLCDegen MedicalEffortmed, LLCFims Co., Ltd.HC Biologics, LLC |
| 10 | LRK | Device, Anti-Snoring | Dental | 15 | Aiomega, LLCAirway Technologies D/B/A Airway ManagementDcstar, Inc.DnB Innovations, LLCDongguan Yiyao Science & Technology Development Co., Ltd. |
| 11 | DYB | Introducer, Catheter | Cardiovascular | 14 | Cardiocycle Medical(Suzhou) Co., Ltd.Cultiv8 1, LLCEcho Medical, LLCHartman Medical Group, LLCHealth Line International Corporation |
| 12 | NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | 13 | Allumin8, Inc.Beijing Fule Science & Technology Development Co., Ltd.Box Spine, LLCChanpin Medtak Co., Ltd.Double Medical Technology, Inc. |
| 13 | OLO | Orthopedic Stereotaxic Instrument | Neurology | 12 | Balmoral Medical, LLCEvolution SpineFoundation Surgical Group, Inc.K2m, Inc.Orthofix US, LLC |
| 14 | IOR | Wheelchair, Mechanical | Physical Medicine | 11 | Anhui Longway Medical Technology Co., Ltd.Empower Ride, LLCFoshan Nanhai Hongchen Medical Equipment Co., Ltd.Free Wheelchair MissionGuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. |
| 15 | NUC | Lubricant, Personal | Obstetrics/Gynecology | 11 | Ansella TherapeuticsGolden Isles Medical, Inc.Guangzhou Haoyimai Trading Co., Ltd.Hudi Pharma SrlLBDO Group, Inc. |
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 |
|---|---|---|---|---|---|---|
| 2026-07-31 | Intuitive Surgical, Inc. | reinforce | NAY | II | Gastroenterology, Urology | da Vinci Surgical System, Model IS5000 |
| 2026-07-31 | Medtronic, Inc. | reinforce | QJZ | II | Cardiovascular | VitalFlow Set with Balance Biosurface |
| 2026-07-31 | Globus Medical, Inc. | reinforce | JWH | II | Orthopedic | ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tib |
| 2026-07-30 | Arthrex, Inc. | KWI | II | Orthopedic | Arthrex Radial Head Replacement System | |
| 2026-07-30 | GE Medical Systems Ultrasound and Primary Care Diagnostics | reinforce | IYN | II | Radiology | LOGIQ Focus |
| 2026-07-30 | Prismatik Dentalcraft, Inc. | reinforce | EIH | II | Dental | Obsidian® Press Over Zirconia |
| 2026-07-30 | Stryker Endoscopy | reinforce | MBI | II | Orthopedic | AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meni |
| 2026-07-29 | Medline Industries, LP | DYB | II | Cardiovascular | NAMIC Dilator and Sheath | |
| 2026-07-28 | Life Spine, Inc. | reinforce | MAX | II | Orthopedic | TruLift Expandable System |
| 2026-07-27 | Philips Ultrasound, LLC | reinforce | IYN | II | Radiology | Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Ser |
| 2026-07-27 | Merit Medical Systems, Inc. | reinforce | DRE | II | Cardiovascular | FlexTract Deflectable-Rotational Dilator Sheath Set |
| 2026-07-24 | Boston Scientific Corporation | reinforce | KRD | II | Cardiovascular | OBSIDIO Conformable Embolic |
| 2026-07-24 | Boston Scientific Corporation | reinforce | LLZ | II | Radiology | TheraSphere 360 Y-90 Management Platform |
| 2026-07-24 | Boston Scientific Corporation | reinforce | DRA | II | Cardiovascular | FARADRIVE Steerable Sheath (M004PF21M402) |
| 2026-07-24 | Fresenius Medical Care Renal Therapies Group, LLC | reinforce | KDI | II | Gastroenterology, Urology | Careflux H60;Careflux H70;Careflux V500 |
| 2026-07-24 | Siemens Healthcare Diagnostics, Inc. | LDP | II | Clinical Toxicology | Atellica CH Acetaminophen 2 (ACTM) | |
| 2026-07-24 | SurGenTec, LLC | reinforce | OLO | II | Neurology | Ion-L Navigated Instruments |
| 2026-07-22 | Merit Medical Systems, Inc. | DXC | II | Cardiovascular | PreludeSYNC Radial Compression Device | |
| 2026-07-17 | Medtronic Sofamor Danek USA, Inc. | reinforce | MAX | II | Orthopedic | Catalyft PL Expandable Interbody System |
| 2026-07-17 | Stryker Endoscopy | SIT | II | Orthopedic | SportSuite Vision Software | |
| 2026-07-16 | Roche Molecular Systems, Inc. | PQA | II | Microbiology | cobas® BV/CV | |
| 2026-07-16 | TriMed, Inc. | reinforce | HRS | II | Orthopedic | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning |
| 2026-07-15 | Abbott Medical | reinforce | DQK | II | Cardiovascular | EnSite X EP System |
| 2026-07-14 | Intuitive Surgical, Inc. | reinforce | GCJ | II | Gastroenterology, Urology | Universal Seal (5-12 mm) |
| 2026-07-14 | Alphatec Spine, Inc. | reinforce | NKB | II | Orthopedic | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal F |
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 | FYC | Gown, Isolation, Surgical | General, Plastic Surgery | 0.0× | 0 | 20 |
| 2 | JDR | Staple, Fixation, Bone | Orthopedic | 0.0× | 0 | 21 |
| 3 | LYY | Latex Patient Examination Glove | General Hospital | 0.0× | 0 | 25 |
| 4 | FLL | Continuous Measurement Thermometer | General Hospital | 0.13× | 2 | 76 |
| 5 | KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | 0.18× | 1 | 28 |
| 6 | FXX | Mask, Surgical | General, Plastic Surgery | 0.21× | 9 | 215 |
| 7 | LZA | Polymer Patient Examination Glove | General Hospital | 0.21× | 15 | 349 |
| 8 | LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | Clinical Chemistry | 0.22× | 1 | 23 |
| 9 | MCW | Catheter, Peripheral, Atherectomy | Cardiovascular | 0.23× | 1 | 22 |
| 10 | MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | Radiology | 0.29× | 4 | 68 |
| 11 | JOJ | Indicator, Physical/Chemical Sterilization Process | General Hospital | 0.31× | 2 | 32 |
| 12 | NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | 0.31× | 2 | 32 |
| 13 | FRN | Pump, Infusion | General Hospital | 0.33× | 2 | 30 |
| 14 | MQC | Mouthguard, Prescription | Unknown | 0.36× | 2 | 28 |
| 15 | FRC | Indicator, Biological Sterilization Process | General Hospital | 0.37× | 2 | 27 |
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.
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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