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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 | — | — | — | — | 3.93× | 11 | 14 | 11 |
| 2 | DHB | — | — | — | 3.0× | 6 | 10 | 1 |
| 3 | SCR | Air-Conduction Hearing Aid Software | Ear, Nose, Throat | II | 3.0× | 3 | 5 | 3 |
| 4 | SDD | Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field | General, Plastic Surgery | II | 3.0× | 3 | 5 | 1 |
| 5 | LOL | Hepatitis A Test (Antibody And Igm Antibody) | Microbiology | II | 3.0× | 3 | 5 | 2 |
| 6 | FMZ | — | — | — | 3.0× | 3 | 5 | 2 |
| 7 | IZQ | — | — | — | 2.86× | 4 | 7 | 3 |
| 8 | KRH | — | — | — | 2.78× | 5 | 9 | 3 |
| 9 | GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | II | 2.73× | 6 | 11 | 4 |
| 10 | OLR | Oral Wound Dressing | Unknown | — | 2.73× | 6 | 11 | 6 |
| 11 | DXT | Injector And Syringe, Angiographic | Cardiovascular | II | 2.69× | 7 | 13 | 6 |
| 12 | GXN | — | — | — | 2.5× | 6 | 12 | 6 |
| 13 | OLI | Fat Reducing Low Level Laser | General, Plastic Surgery | II | 2.5× | 5 | 10 | 4 |
| 14 | GXP | Methyl Methacrylate For Cranioplasty | Neurology | II | 2.5× | 4 | 8 | 2 |
| 15 | LYC | Bone Grafting Material, Synthetic | Dental | II | 2.5× | 4 | 8 | 4 |
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 | 40 | 3DIEMME SRLAgada Medical, Ltd.Ai4medimaging Medical Solutions S.A.Airs Medical, Inc.Angiowave Imaging, Inc. |
| 2 | LLZ | System, Image Processing, Radiological | Radiology | 36 | ADVAHEALTH SOLUTIONS, LLCAS Software, LLCAgfa Healthcare N.V.Apryse Software CorpArchy Dental, Inc. |
| 3 | GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 25 | 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 | LRK | Device, Anti-Snoring | Dental | 15 | Aiomega, LLCAirway Technologies D/B/A Airway ManagementDcstar, Inc.DnB Innovations, LLCDongguan Yiyao Science & Technology Development Co., Ltd. |
| 9 | 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. |
| 10 | ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | 15 | C.A. Medical, LLCDegen MedicalEffortmed, LLCFims Co., Ltd.HC Biologics, LLC |
| 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 | IOR | Wheelchair, Mechanical | Physical Medicine | 12 | 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. |
| 14 | DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | 12 | 80 Beats Medical GmbHBeijing Hanvon Health Technology Co., Ltd.Biozen, LLCDongguan E-Test Technology Co., Ltd.Guangzhou Daxin Health Technology Co., Ltd. |
| 15 | OLO | Orthopedic Stereotaxic Instrument | Neurology | 12 | Balmoral Medical, LLCFoundation Surgical Group, Inc.K2m, Inc.Life Spine, 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 |
|---|---|---|---|---|---|---|
| 2026-08-13 | GE Medical Systems | reinforce | LNH | — | — | AIR Recon DL |
| 2026-08-12 | Boston Scientific | FTM | II | General, Plastic Surgery | EluPro Antibiotic-Eluting BioEnvelope | |
| 2026-08-12 | Masimo Corporation | reinforce | MWI | — | — | Masimo Root Monitoring System |
| 2026-08-12 | Hologic, Inc. | KNW | II | Gastroenterology, Urology | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) | |
| 2026-08-12 | TriMed, Inc. | reinforce | HWC | II | Orthopedic | Large Compression Screws |
| 2026-08-10 | Siemens Healthcare Diagnostics, Inc. | NIG | — | — | Atellica IM CA 19-9 II | |
| 2026-08-07 | Arthrex, Inc. | reinforce | MAI | II | Orthopedic | Arthrex Bioabsorbable PushLock Suture Anchors |
| 2026-08-07 | Intuitive Surgical, Inc. | FDS | — | — | Intuitive Endoluminal Gastrointestinal System (IG1000) | |
| 2026-08-07 | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | reinforce | IYN | II | Radiology | Venue Go |
| 2026-08-06 | Paragon 28, Inc. | reinforce | JDR | II | Orthopedic | Megalodon Dynamic Compression System |
| 2026-08-06 | Howmedica Osteonics Corp. dba Stryker Orthopaedics | reinforce | KRO | — | — | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total K |
| 2026-08-04 | Globus Medical, Inc. | reinforce | LPH | II | Orthopedic | TRIVANCE Hip Stem |
| 2026-08-04 | Philips Ultrasound, LLC | reinforce | IYN | II | Radiology | Alturion Series Diagnostic Ultrasound System |
| 2026-08-03 | Varian Medical Systems, Inc. | reinforce | IYE | — | — | Halcyon, Ethos Radiotherapy System (5.0) |
| 2026-08-03 | Paragon 28, Inc. | reinforce | MBI | II | Orthopedic | Grappler Suture Anchor System |
| 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 |
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 | LYY | — | — | 0.0× | 0 | 23 |
| 2 | FLL | Continuous Measurement Thermometer | General Hospital | 0.13× | 2 | 75 |
| 3 | LZA | — | — | 0.18× | 12 | 341 |
| 4 | LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | Clinical Chemistry | 0.22× | 1 | 23 |
| 5 | FXX | — | — | 0.22× | 9 | 203 |
| 6 | JDR | Staple, Fixation, Bone | Orthopedic | 0.23× | 1 | 22 |
| 7 | MCW | Catheter, Peripheral, Atherectomy | Cardiovascular | 0.24× | 1 | 21 |
| 8 | JOJ | — | — | 0.31× | 2 | 32 |
| 9 | NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | 0.31× | 2 | 32 |
| 10 | MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | Radiology | 0.31× | 4 | 65 |
| 11 | KGO | — | — | 0.33× | 2 | 30 |
| 12 | FRN | Pump, Infusion | General Hospital | 0.33× | 2 | 30 |
| 13 | LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | Microbiology | 0.33× | 2 | 30 |
| 14 | KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | 0.34× | 2 | 29 |
| 15 | PGY | Display, Diagnostic Radiology | Radiology | 0.35× | 3 | 43 |
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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