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 |
|---|---|---|---|---|---|
| K001931 | Wako Autokit Lp(a) & Lp(a) Calibrator/aeroset | FUJIFILM Healthcare Americas Corporation | DFC | Class II | |
| K001929 | Wako Autokit Lp(a) and Lp(a) Calibrator/cobas Fara | FUJIFILM Healthcare Americas Corporation | DFC | Class II | |
| K001890 | Sherpa/kodiak Cub Mobility System (Manual Wheelchair) | Otto Bock Orthopaedische Industrie, KG. | IOR | Class I | |
| K001777 | Model Cgs Tilt Seating System for Power Wheelchairs | Invacare GmbH | ITI | Class II | |
| K001558 | Sensititre 18-24 Hours Susceptibility Plates (Quinupristin/dalfopristin) | Trek Diagnostic Systems, Ltd. | JWY | Class II | |
| K001407 | Surgitron Iec II | Ellman Intl., Inc. | GEI | Class II | |
| K001391 | Bonus Mechanical Wheelchair | Bonus Ent. Corp. | IOR | Class I | |
| K001032 | Rlp-Cholesterol Immunoseparation Assay | Otsuka Pharmaceutical Co., Ltd. | CHH | Class I | |
| K000580 | Zurich Pediatric Maxillary Distractor, Models 51-550-15 and 51-551-15 | KLS-Martin L.P. | MQN | Class II | |
| K001921 | Wako Autokit Lp(a)/express 550 | FUJIFILM Healthcare Americas Corporation | DFC | Class II | |
| K001920 | Wako Autokit Lp(a)/ Ra,500/1000, | FUJIFILM Healthcare Americas Corporation | DFC | Class II | |
| K001919 | Wako Autokit Lp(a)/dade Demension | FUJIFILM Healthcare Americas Corporation | DFC | Class II | |
| K994141 | Catheter, Intravascular Occluding, Temporary, Model Sol 3510; Wire, Guide, Catheter, Model Qsw1000 | Medtronic, Inc. | MJN | Class II | |
| K992414 | Proton Beam Therapy System (Pbts) | Optivus Technology, Inc. | LHN | Class II | |
| K002046 | Modification to Automated Non-Invasive Blood Pressure Monitor, Model Bpm-100 | Vsm Technology, Inc. | DXN | Class II | |
| K001876 | Take 1 Bite | Sybron Dental Specialties, Inc. | ELW | Class II | |
| K001750 | Medis 5Mp1h Quad-Head Medicial Diagnostic Display System | Barco NV Display Systems | LLZ | Class II | |
| K001541 | Minicam | Video Dental Concepts, Inc. | EIA | Class I | |
| K001530 | The Bioplate Bioclip Craniotomy Fixation System | Bioplate Inc | JEY | Class II | |
| K001446 | Light-Cured Orthodontic Band Cement | Scientific Pharmaceuticals, Inc. | DYH | Class II | |
| K001426 | Kawasumi Laboratories IV Administration Set with Filter | Kawasumi Laboratories America, Inc. | FPA | Class II | |
| K001424 | Kawasumi Laboratories IV Administration Set, Standard | Kawasumi Laboratories America, Inc. | FPA | Class II | |
| K001423 | Kawasumi Laboratories IV Administration Set, Primary | Kawasumi Laboratories America, Inc. | FPA | Class II | |
| K001390 | Biosense Webster Patient Cable and Leadwires | Biosense Webster Inc | DSA | Class II | |
| K001317 | Aria | Del Mar Medical Systems, LLC | MWJ | Class II | |
| K001050 | Calciject | Centrix, Inc. | EJK | Class II | |
| K000610 | Resolution Cholesterol Monitor | Lifestream Technologies, Inc. | CHH | Class I | |
| K993205 | Booker Box, Model Pad 5010 | TZ Medical Inc. | LDD | Class II | |
| K991279 | Medi-Cult Universal Ivf-Medium | Medicult A/S | MQL | Class II | |
| K002126 | Abbott Acclaim Encore Standard Tubing Pump | Abbott Medical | FRN | Class II | |
| K001966 | Rebar Micro Catheter: Rebar-18 [2.3F], 110 Cm, 130 Cm, 153 Cm, Single Marker Band and 153 Cm, Dual Marker Band | Medtronic, Inc. | KRA | Class II | |
| K001932 | Tornier Cement Restrictor | TORNIER Inc. | JDI | Class II | |
| K001930 | Model 8500, Hand Held Pulse Oximeter, Model 8500 | Nonin Medical, Inc | DQA | Class II | |
| K001885 | Vitros Chemistry Products Bun/urea Slides and Vitros Chemistry Products Calibrator Kit 1 | Ortho-Clinical Diagnostics, Inc. | CDN | Class II | |
| K001864 | Synthes Cervifix System | Synthes GmbH | KWQ | Class II | |
| K001376 | Ti-Max Protrusio Cage | Zimmer GmbH | JDI | Class II | |
| K001357 | Modification to Omega 21 System | Ebi, LLC | KWQ | Class II | |
| K001318 | CPAP System, Model 102001 | Abbott Medical | BYE | Class II | |
| K001306 | Stethos, Model Stxxyyzz or 001 Xxx, Stethos Link, Model Slxxyyzz or 002 Xxx | Andromed, Inc. | DQD | Class II | |
| K001288 | Dr180-II | North East Monitoring, Inc. | MWJ | Class II | |
| K001087 | Pta Balloon Catheter | Cook Inc. | LIT | Class II | |
| K994214 | Gem Knee System | Kinamed Inc | JWH | Class II | |
| K993909 | Nanma Vacuum Pump | Nanma Mfg Co., Ltd. | LKY | Class II | |
| K993684 | Spinal Pad | Bioscan, Inc. | ILY | Class II | |
| K993420 | Control Solutions Inc, Model Cs3101 | Control Solutions, Inc. | IPF | Class II | |
| K002084 | Microvasive Lithotriptor Flexprobe II | Boston Scientific Corporation | FFK | Class II | |
| K001936 | Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord | ArthroCare Corporation | GEI | Class II | |
| K001844 | Modification to Centaur Spinal System | Howmedica Osteonics Corp | KWQ | Class II | |
| K001754 | Medis 5Mp1h Dual-Head Medical Diagnostic Display System | Barco NV Display Systems | LLZ | Class II | |
| K001752 | Medis 55Mp1h Single-Head Medical Diagnostic Display System | Barco NV Display Systems | LLZ | Class II |