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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 | — | — | — | — | 4.06× | 13 | 16 | 13 |
| 2 | DHB | System, Test, Radioallergosorbent (Rast) Immunological | Immunology | II | 3.18× | 7 | 11 | 2 |
| 3 | 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 |
| 4 | FMZ | Incubator, Neonatal | General Hospital | II | 3.0× | 3 | 5 | 2 |
| 5 | LLL | Extractable Antinuclear Antibody, Antigen And Control | Immunology | II | 3.0× | 3 | 5 | 3 |
| 6 | OLT | Non-Normalizing Quantitative Electroencephalograph Software | Neurology | II | 2.86× | 4 | 7 | 4 |
| 7 | GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | II | 2.73× | 6 | 11 | 4 |
| 8 | OLR | Oral Wound Dressing | Unknown | — | 2.73× | 6 | 11 | 6 |
| 9 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | Neurology | II | 2.73× | 6 | 11 | 6 |
| 10 | MOF | Guide, Wire, Catheter, Neurovasculature | Cardiovascular | II | 2.5× | 11 | 22 | 7 |
| 11 | OLI | Fat Reducing Low Level Laser | General, Plastic Surgery | II | 2.5× | 5 | 10 | 4 |
| 12 | MMK | Container, Sharps | General Hospital | II | 2.5× | 5 | 10 | 5 |
| 13 | SAN | Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples | Microbiology | II | 2.5× | 4 | 8 | 4 |
| 14 | LXB | Hearing Aid, Bone Conduction | Ear, Nose, Throat | II | 2.5× | 4 | 8 | 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 | 3DIEMME SRLAI Planning Logic, Inc.Agada Medical, Ltd.Ai4medimaging Medical Solutions S.A.Anumana, 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 | 24 | Baoding Te'Anzhou Electronic Technology Co., Ltd.Beijing HuaCheng Taike Technology Co., Ltd.Bellamia Technologies, Inc.Boston Aesthetics, Inc.C.R. Bard, Inc. |
| 4 | ITI | Wheelchair, Powered | Physical Medicine | 22 | Beijing OrionStar Technology Co., Ltd.Foshan Sowell Medical Technology Co., Ltd.Hebei Dansong Medical Technology Co., Ltd.Jiangsu Intco Medical Products Co., Ltd.Jiangsu Yveelt Medical Equipment Co., Ltd. |
| 5 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 21 | Acotec Scientific Co., Ltd.Ascblue CorporationAsterasys Co., Ltd.Aventix Medical, Inc.Baylis Medical Technologies, Inc. |
| 6 | OHS | Light Based Over The Counter Wrinkle Reduction | General, Plastic Surgery | 21 | Atop Lighting Co., Ltd.Dongguan Miqiang Technology Co., Ltd.Dongguan Yijiaming Technology Co., Ltd.Guangdong Ace-Tec Co., Ltd.Kam Yuen Plastic Products , Ltd. |
| 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 | DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | 13 | 80 Beats Medical GmbHBeijing Hanvon Health Technology Co., Ltd.Biozen, LLCGuangzhou Daxin Health Technology Co., Ltd.Happy Health, Inc. |
| 11 | 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. |
| 12 | LRK | Device, Anti-Snoring | Dental | 13 | Aiomega, LLCDcstar, Inc.DnB Innovations, LLCDongguan Yiyao Science & Technology Development Co., Ltd.Endeavor Commerce, LLC |
| 13 | DYB | Introducer, Catheter | Cardiovascular | 13 | Cardiocycle Medical(Suzhou) Co., Ltd.Cultiv8 1, LLCEcho Medical, LLCHartman Medical Group, LLCHealth Line International Corporation |
| 14 | — | — | — | 13 | 41Medical AGBiotracker, LLCCardinalhealthCepheidDiazyme Laboratories, Inc. |
| 15 | NUC | Lubricant, Personal | Obstetrics/Gynecology | 12 | Ansella TherapeuticsBumlicious, LLC (DBA Bumlicious)Golden Isles Medical, Inc.Guangzhou Haoyimai Trading Co., Ltd.Hudi Pharma Srl |
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 |
|---|---|---|---|---|---|---|
| 2026-09-11 | Boston Scientific Corporation | reinforce | OVB | II | Radiology | SpaceOAR Flex System |
| 2026-09-10 | Siemens Medical Solutions USA, Inc. | reinforce | OBJ | II | Cardiovascular | ACUNAV Luxera 4D ICE Catheter |
| 2026-09-08 | Intuitive Surgical, Inc. | reinforce | NAY | II | Gastroenterology, Urology | da Vinci Surgical System, Model IS5000 |
| 2026-09-08 | Smith & Nephew, Inc. | reinforce | MBH | II | Orthopedic | LANDMARK Total Knee System |
| 2026-09-04 | Dentsply Sirona, Inc. | reinforce | KCT | II | General Hospital | Surgical and Prosthetic Trays |
| 2026-09-03 | Boston Scientific | reinforce | KNS | II | Gastroenterology, Urology | Rezum System |
| 2026-09-02 | GE Medical Systems Ultrasound and Primary Care Diagnostics | reinforce | IYN | II | Radiology | Vivid Explorer/Vivid Advanced/Vivid Focus |
| 2026-09-02 | Hologic, Inc. | MUE | II | Radiology | I-View® | |
| 2026-09-01 | Arthrex, Inc. | reinforce | JDR | II | Orthopedic | Arthrex DynaNite Staples |
| 2026-08-31 | Siemens Medical Solutions USA, Inc. | reinforce | KPR | II | Radiology | MULTIX Impact; MULTIX Impact C |
| 2026-08-28 | Medtronic, Inc. | reinforce | MXD | II | Cardiovascular | LINQ II Insertable Cardiac Monitor (ICM) (LNQ22) |
| 2026-08-28 | Paragon 28, Inc. | HTY | II | Orthopedic | Primal K-Wire (P99-193-1410) | |
| 2026-08-28 | Roche Molecular Systems, Inc. | PGX | II | Microbiology | cobas Strep A Nucleic acid test for use on the cobas Liat System (0734 | |
| 2026-08-28 | Roche Molecular Systems, Inc. | reinforce | OZN | II | Microbiology | cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (074 |
| 2026-08-27 | Prismatik Dentalcraft, Inc. | reinforce | EBI | II | Dental | Glidewell Denture Base Resin |
| 2026-08-27 | Riverpoint Medical | reinforce | MBI | II | Orthopedic | Iconix Knotless T |
| 2026-08-26 | Boston Scientific Corporation | reinforce | FGB | II | Gastroenterology, Urology | LithoVue Elite Digital Flexible Ureteroscope System |
| 2026-08-26 | SurGenTec, LLC | reinforce | FMF | II | General Hospital | GraftGun Universal Graft Delivery System (GDS®) |
| 2026-08-24 | SurGenTec, LLC | reinforce | OUR | II | Orthopedic | TiLink-L SI Joint Fusion System |
| 2026-08-21 | Boston Scientific | reinforce | DQK | II | Cardiovascular | AVVIGO+ Multi-Modality Guidance System |
| 2026-08-21 | Medtronic, Inc. | reinforce | DQK | II | Cardiovascular | Affera Integrated Mapping System |
| 2026-08-21 | Dentsply Sirona | reinforce | QIH | II | Radiology | DS Core CBCT Anatomy |
| 2026-08-21 | Inari Medical, Inc. | reinforce | QEW | II | Cardiovascular | Artix MT;Artix Thin-Walled Sheath |
| 2026-08-19 | Roche Diagnostics | reinforce | SET | II | Immunology | Elecsys Phospho-Tau (217P) Plasma |
| 2026-08-13 | GE Medical Systems | reinforce | LNH | II | Radiology | AIR Recon DL |
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 | LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | Clinical Chemistry | 0.0× | 0 | 23 |
| 2 | OCX | Endoscopic Irrigation/Suction System | Gastroenterology, Urology | 0.0× | 0 | 23 |
| 3 | LYY | Latex Patient Examination Glove | General Hospital | 0.0× | 0 | 22 |
| 4 | FLL | Continuous Measurement Thermometer | General Hospital | 0.15× | 2 | 68 |
| 5 | FRC | Indicator, Biological Sterilization Process | General Hospital | 0.19× | 1 | 27 |
| 6 | FXX | Mask, Surgical | General, Plastic Surgery | 0.21× | 8 | 187 |
| 7 | ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | General, Plastic Surgery | 0.24× | 1 | 21 |
| 8 | LZA | Polymer Patient Examination Glove | General Hospital | 0.24× | 16 | 339 |
| 9 | JSM | Culture Media, Non-Propagating Transport | Microbiology | 0.25× | 1 | 20 |
| 10 | JOJ | Indicator, Physical/Chemical Sterilization Process | General Hospital | 0.32× | 2 | 31 |
| 11 | MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | Radiology | 0.32× | 4 | 63 |
| 12 | FRN | Pump, Infusion | General Hospital | 0.33× | 2 | 30 |
| 13 | LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | Microbiology | 0.34× | 2 | 29 |
| 14 | KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | 0.36× | 2 | 28 |
| 15 | KGO | Surgeon'S Gloves | General, Plastic Surgery | 0.36× | 2 | 28 |
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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