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 |
|---|---|---|---|---|---|
| K914221 | Kpe 220 Ts, Nonsterile | Ipax, Inc. | HQE | Class II | |
| K914172 | Kpe 230 Am | Ipax, Inc. | HQC | Class II | |
| K914163 | Scoptopic Sensitivity Test-1[Sst-1] | LKC Technologies, Inc. | HLX | Class II | |
| K914125 | Ferno Ille Hi-Lo Jr. Mobile Whirlpool, Model 403 | Ferno | ILJ | Class II | |
| K913646 | Ciba Corning Acs T3 Immunoassay | Ciba Corning Diagnostics Corp. | CDD | Class II | |
| K913590 | Microlite Ml 1000 Microtiter Plate Luminometer | Dynatech Laboratories, Inc. | JJQ | Class I | |
| K913466 | Abbott Quickstart Direct Bilirubin (Dbil) #5A20 | Em Diagnostic Systems, Inc. | CIG | Class II | |
| K913434 | Ventrex Coated Tube Intact Pth | Ventrex Laboratories, Inc. | CEW | Class II | |
| K913375 | Torque Tube Steerocath(tm) | Ep Technologies, Inc. | DRF | Class II | |
| K913372 | Ips Empress | Ivoclar North America, Inc. | EIH | Class II | |
| K913073 | Dobbhoff(r) Percutaneous Transhepat Biliary Stent | Biosearch Medical Products, Inc. | FGE | Class II | |
| K912178 | Bio TENS 601, 606 and 608 (3000) | Skylark Device Co., Ltd. | GZJ | Class II | |
| K911972 | Freeman-Samuelson Modular Total Knee Replacement | Intermedics Orthopedics | JWH | Class II | |
| K911354 | Sterile Plain Gut/chromic Gut Absorb Surg Sutures | Internacional Farmaceutica, S.A. de C.V. | GAL | Class II | |
| K904520 | Ray Sacral Fixation System | Danek Medical, Inc. | KWP | Class II | |
| K914434 | Polar Pads | Breg, Inc. | ILO | Class II | |
| K914344 | Multi-Reach II Wand Massager | Conair LLC. | IRO | Class I | |
| K913989 | 510 Dl Powered Wheelchairs | Am Scooters | INI | Class II | |
| K913759 | Duet Bicycle/wheelchair | Robert Hoening Mobility Systems, Inc. | IOR | Class I | |
| K913518 | Ta620 Treadmill Controller | Siemens Burdick, Inc. | IOL | Class I | |
| K912362 | Oes Thoracoscope System | Olympus Corp. | EWY | Class II | |
| K912058 | Gauntlet Stair Climber | Tri-Tech, Inc. | ISD | Class II | |
| K912057 | 4000 Pt Exercise System | Tri-Tech, Inc. | ISD | Class II | |
| K912056 | Gravitron Upper Body System Exerciser | Tri-Tech, Inc. | ISD | Class II | |
| K911756 | Posterior Nasal Epistaxis Instruments | Richard Wolf Medical Instruments Corp. | ECB | Class I | |
| K911584 | Diagnostic Ultrasound System Model Sc480 | Pie Medical Equipment B.V. | IYO | Class II | |
| K911562 | Editor Mp 800/Hf-850 X-Ray Control and Generator | Continental X-Ray Corp. | IZO | Class I | |
| K911307 | Crosslink Plate | Danek Medical, Inc. | KWP | Class II | |
| K914462 | Sri Progesterone Enzyme Immunoassay(mag Sold Phas) | Serono-Baker Diagnostics, Inc. | JLS | Class I | |
| K914439 | P.f.c.(tm) Unicondylar Knee Syst, Por Coat Femoral | Johnson & Johnson Orthopaedics, Inc. | HSX | Class II | |
| K914365 | Dexon Dissecting Sponge | Davis & Geck, Inc. | GAK | Class II | |
| K914322 | Baritone C2 & Baritone L3 | Confi-Dental Products Co. | EBC | Class II | |
| K914319 | Pit and Fissure Sealant Products | Confi-Dental Products Co. | EBC | Class II | |
| K914314 | Fortex(tm) Wound Dressing | Calgon Vestal Div. | KMF | Class I | |
| K914207 | Clearsite(r) Sterile Wound Care Dressing | Ndm Acquisition Corp. | NAE | Class I | |
| K914183 | Bivona Cuff Maintenance Device (Cmd) | Bivona Medical Technologies | JOH | Class II | |
| K914141 | Cordis Dual Lumen Pressure Monitoring Catheter | Cordis US Corp. | DQO | Class II | |
| K914088 | Bivona Aire-Cuf(r) Pediatric Tracheostomy Tube | Bivona Medical Technologies | JOH | Class II | |
| K914049 | Multiple Latex Patient Examination Gloves | London Rubber Co. (India), Ltd. | LYY | Class I | |
| K913964 | Marlow/reddick Laparoscopic Grasping Forceps | Marlo Surgical Technology | HTD | Class I | |
| K913962 | Anomaloscope Quadrant Test-6 | LKC Technologies, Inc. | HIW | Class I | |
| K913753 | Bodai Neo2 -Safe Airway Pressure Cap | B & B Medical Technologies, Inc. | CAI | Class I | |
| K913734 | Bair Hugger(r) Patient Warm Syst/baby Warm Cover | Augustine Medical, Inc. | DWJ | Class II | |
| K913630 | Multispect 2 Dual Detector Camera System | Siemens Gammasonics, Inc. | KPS | Class II | |
| K913587 | Jtech 50 Series Cutting Loop | J-Tech, Inc. | FJL | Class II | |
| K913525 | Mobile X-Ray System | Siemens Medical Solutions USA, Inc. | OXO | Class II | |
| K913471 | Cirrus Gamma Camera | Philips North America LLC | KPS | Class II | |
| K913353 | Vascular Guide Wire | Advanced Cardiovascular Systems, Inc. | DQX | Class II | |
| K913349 | Stambi-Ck | Intl. Immunoassay Laboratories, Inc. | JHW | Class II | |
| K913333 | i.v. Priming Set | Gainor Medical Europe, Ltd. | FPA | Class II |