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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K851345 | Purple Broth | Micro Media Laboratories | JSH | Class I | |
| K851343 | Brom Cresol Purple Starch | Micro Media Laboratories | JSH | Class I | |
| K851277 | Microspiro-Sds | Medical Equipment Designs, Inc. | BZG | Class II | |
| K851248 | Amendment Lifepak 100, Npn 045 | Physio Control, Inc. | DRO | Class II | |
| K851247 | Amendment Lifepak 200, Npn 046 | Physio Control, Inc. | DRO | Class II | |
| K851246 | Numed Balloon Pacing Catheter | Numed Inc | LDF | Class II | |
| K851145 | Pacesetter Systems Inc. Endocardial Finned Lead | Pacesetter Systems | DTD | Class II | |
| K851078 | Hdc Silcath Subclavian Catheter Percutaneous Inser | Hdc Corp. | DYB | Class II | |
| K850886 | Compression Hip Screw System | Pfizer Inc | KIT | Class I | |
| K850770 | Intermedics Bone Screw | Intermedics Orthopedics | HWC | Class II | |
| K850623 | Oscor Medical Implantable Pacing Lead, Retractable | Oscor Medical Corp. | DTB | Class III | |
| K850618 | Fc-700 Defibrillator | Fukuda Denshi USA, Inc. | LDD | Class II | |
| K850444 | Mec Butress Plate | Pfizer Inc | HRS | Class II | |
| K850442 | Mec Broad Bone Plate | Pfizer Inc | HRS | Class II | |
| K850441 | Mec Intramedullary Rod | Pfizer Inc | HSB | Class II | |
| K850401 | Letournel Acetabular Plate | Pfizer Inc | HRS | Class II | |
| K850160 | Fisher Diagnostics Latest-Crp Test Kit | Fisher Diagnostics | DCK | Class II | |
| K850080 | Digital Image Processor Fp-2C | Eigen Video | LLZ | Class II | |
| K850067 | Medical, Disposable Bedding | East Texas Lighthouse for the Blind | KME | Class I | |
| K845025 | Austin-Moore Modular Hip Prosthesis | Zimmer GmbH | KWL | Class II | |
| K844787 | Biometric Total Hip System | Biomedics | JDI | Class II | |
| K844485 | Ceryx6, 611, Ceryx 3 311 & Ceryx 1 111 | Vitatron Medical BV | KRG | Class III | |
| K844483 | Tp 1 | Vitatron Medical BV | KRG | Class III | |
| K841434 | Varicella-Zoster(igg) Ifa Test | Zeus Scientific LLC | GQW | Class II | |
| K851255 | Sun Beds | Tannhut | FTC | Class II | |
| K850794 | Patient Monitor Model Rm-300 | Honeywell, Inc. | DTR | Class II | |
| K850678 | Aim N' Shoot - Automatic Exposure Control | Fairchild Medical Systems, Inc. | IZL | Class II | |
| K850407 | Neonatal Monitor 309 | Rigel Medical Electronics, Inc. | DRT | Class II | |
| K850343 | Display Monitor (Vd-711Ra-Vd-712Ra) | Nihon Kohden America Inc | DXJ | Class II | |
| K850318 | Unisonic Electronic Digital Bp Monitor Emb-4050 | Nihon Seimitsu Sokki Co., Ltd. | DXN | Class II | |
| K850290 | Ultrasound Gel | Litton Datamedix | IYO | Class II | |
| K850166 | Telemanometer | R.J. Ash, Medical Monitoring, Inc. | DRG | Class II | |
| K844842 | Neos-Lp Pulse Generator | Biotronik Sales, Inc. | DXY | Class III | |
| K844841 | Kalos-04 Pulse Generator | Biotronik Sales, Inc. | DXY | Class III | |
| K844835 | Nd2100 Spine Scanner | Nuclear Data, Inc. | KGI | Class II | |
| K844812 | Neos - Pulse Generator | Biotronik Sales, Inc. | DXY | Class III | |
| K844795 | Neos-M Pulse Generator | Biotronik Sales, Inc. | DXY | Class III | |
| K844794 | Leptos Pulse Generator | Biotronik Sales, Inc. | DXY | Class III | |
| K844397 | Pollenex Digital Sphygmomanometer Bp-4000 | Associated Mills, Inc. | DSK | Class II | |
| K844396 | Pollenex Digital Sphygmomanometer Bp-2000 | Associated Mills, Inc. | DSK | Class II | |
| K844310 | Blood-Pressure ECG Transmitter | Instromedix, Inc. | DXN | Class II | |
| K844299 | Corneomap 4500 | Radionics Medical, Inc. | IYO | Class II | |
| K844285 | Copal Digital Sphygmomamometer Ua-550 | Takeda Medical, Inc. | DXN | Class II | |
| K843994 | Ausonics 357 | Ausonics Pty, Ltd. | IYO | Class II | |
| K843971 | Ausonics 150 | Ausonics Pty, Ltd. | IYO | Class II | |
| K851308 | Analytes Albumin, Total Bilirubin, Ast, Alt Gen2 S | Technicon Instruments Corp. | CIX | Class II | |
| K851278 | Acetazyme, Stanbio Acetaminophen Proc/test 0870 | Stanbio Laboratory | LDP | Class II | |
| K851022 | Single Leg Mayfield Table | Ohio Medical Instrument Co., Inc. | |||
| K850947 | V-Mueller Inverted Linear Anastomosis Instruments | American V. Mueller | GAG | Class II | |
| K850904 | Alba Dry Burn Dressing | Alba Health Care | NAD | Class I |