510(k) clearances
Premarket notifications cleared by FDA, newest decision first.
Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.
Data as of , the FDA export date. FDA 510(k) database
Clearances by decision year
Last 15 yearsShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 3,135 |
| 2013 | 3,052 |
| 2014 | 3,202 |
| 2015 | 3,020 |
| 2016 | 2,956 |
| 2017 | 3,200 |
| 2018 | 3,062 |
| 2019 | 2,918 |
| 2020 | 2,923 |
| 2021 | 3,023 |
| 2022 | 3,209 |
| 2023 | 3,346 |
| 2024 | 3,129 |
| 2025 | 3,225 |
| 2026 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K002691 | Com-Med o.r. Towel - Non-Sterile, Blue, Green, White | Com-Med International, Inc. | KKX | Class II | |
| K002614 | Advent Implant System | Core-Vent Corp. | DZE | Class II | |
| K002403 | Novofine 31 Disposable Needle | Novo Norodisk Pharmaceuticals, Inc. | FMI | Class II | |
| K001895 | Auto Suture Premium Plus Ceea Disposable Stapler | United States Surgical, A Division of Tyco Healthc | GDW | Class II | |
| K001669 | Hanger Cranial Band | Hanger Orthopedic Group, Inc. | MVA | Class II | |
| K000594 | Locking Screw Mandibular Reconstruction Plate | Stryker Leibinger | JEY | Class II | |
| K003452 | Polaris X Catheters, Model 7000D,7001d,7003d,7004d,7005d,7006d | Ep Technologies, Inc. | DRF | Class II | |
| K003450 | Intrastent Doublestrut Paramount Biliary Endoprosthesis | Intratherapeutics, Inc. | FGE | Class II | |
| K003448 | Dextran Serum Supplement (Dss), Model 9301 | FUJIFILM Biosciences Inc. | MQL | Class II | |
| K002481 | Zynergy Featherpace Transvenous Bipolar Catheter, Model 04-X-02-3-10-3 | Zcv,Inc. | LDF | Class II | |
| K001866 | Tcm400 | Radiometer Medical ApS | LPP | Class II | |
| K003483 | Modified Hydrophilic Coated Guidewire (Stainless Steel Core) | Lake Region Mfg., Inc. | DQX | Class II | |
| K003469 | Eecp Therapy System, Model Ts3 | Vasomedical, Inc. | DRN | Class II | |
| K003455 | Modification to Chad Therapeutics Oxymatic Model 401 | Chad Therapeutics, Inc. | NFB | Class II | |
| K002798 | Codman Craniosorb Absorbable Fixation System Drill Bits | Cerenovus, Inc. | JEY | Class II | |
| K002795 | Model Hybrid 3200 Monoplace, Hyperbaric Therapy Systems | Hypertec, Inc. | CBF | Class II | |
| K002794 | Model 5000 Multiplace Hyperbaric Therapy | Hypertec, Inc. | CBF | Class II | |
| K002232 | Aedefibrillator | Medical Research Laboratories, Inc. | MKJ | Class III | |
| K002135 | Sleepstrip Disposable Apnea Screener | Influent, Ltd. | MNR | Class II | |
| K001976 | Stc Barbiturates Intercept Micro-Plate Eia, Model 1108I | OraSure Technologies, Inc. | DIS | Class II | |
| K001621 | Dardik Carotid Shunt | Vascutech, Inc. | MJN | Class II | |
| K003582 | Fluidsense Fluid Delivery System Model Fs-01 | Fluidsense Corp. | FRN | Class II | |
| K003327 | Albumin | JAS Diagnostics/Drew Scientific | CIX | Class II | |
| K003291 | Bayer Diagnostics Acs:180 and Advia Centaur Anti-Tpo Assay | Bayer Diagnostics Corp. | JZO | Class II | |
| K003209 | Urine Opiates (Opi) Screen Flex Reagent Cartridge, Catalog No. Df93a | Siemens Healthcare Diagnostics Inc. | DJG | Class II | |
| K003141 | Ubm Plus, Model P45 | Paradigm Medical Industries, Inc. | IYO | Class II | |
| K003039 | Gold Core II | Jeneric/Pentron, Inc. | EJH | Class II | |
| K003037 | Jewel Cast III | Jeneric/Pentron, Inc. | EJH | Class II | |
| K002894 | Mediprime | Algotec Systems, Ltd. | LLZ | Class II | |
| K002783 | Fixion Interlocking Nail (Fixion Il Nail) | Disco-O-Tech Medical Technologies, Ltd. | HSB | Class II | |
| K002782 | Hermes Hd Aq Acquisition Station and Hermes Workstation | Nuclear Diagnostics, Inc. | LLZ | Class II | |
| K002775 | Distal Volar Radius Fracture Repair System | Hand Innovations, Inc. | HRS | Class II | |
| K002768 | Acapella | Dhd Healthcare Corp. | BWF | Class II | |
| K002128 | Active Inhibin-a Elisa, Model Dsl-10-28100 | Diagnostic Systems Laboratories, Inc. | NDR | Class I | |
| K002105 | Siemens Infinity Sc 6002Xl Enhanced with St Segment Analysis | Siemens Medical Solutions USA, Inc. | MLD | Class II | |
| K001465 | Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set | Nipro Medical Corporation | FIB | Class II | |
| K000582 | Freestyle Blood Glucose Monitoring System, Cat No 11001 | Abbott Medical | LFR | Class II | |
| K994078 | U1 Hip System | United Orthopedic Corp. | LPH | Class II | |
| K003587 | Clearglide Precision Bipolar Device | Ethicon, Inc | GEI | Class II | |
| K003377 | Fermit N Plus | Ivoclar North America, Inc. | EBG | Class II | |
| K003374 | Fermit Plus | Ivoclar North America, Inc. | EBG | Class II | |
| K003245 | Heparin Lock Flush Syring 10 Usp Units/ml, Heparin Lock Flush Syringe, 100 Usp Units/ml | Baxter Healthcare Corporation | FOZ | Class II | |
| K003029 | Infusomat P | B.Braun Medical, Inc. | FRN | Class II | |
| K002987 | Redtronic Xomed Monopolar Energized Blade | Xomed, Inc. | GEI | Class II | |
| K002941 | Acetabular Plates | Encore Orthopedics, Inc. | LWJ | Class II | |
| K002893 | Fluorolab Plus | Z-Kat, Inc. | HAW | Class II | |
| K002884 | Paradigm-Fotona Yaplase Nd:yap Laser System and Accessories | Fotona D.D. | GEX | Class II | |
| K002853 | Sciton Image Hair Removal Laser | Sciton, Inc. | GEX | Class II | |
| K002761 | Fresnius Hemoflow F7nr, F50nr, F70nr Hemodialyzers | Fresenius Medical Care Renal Therapies Group, LLC | FJI | Class II | |
| K002755 | Non-Absorbing Sternatomy Monofilament Suture | T. Korossurgical Instruments Corp. | LRN | Class II |