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 |
|---|---|---|---|---|---|
| K910603 | Loop Retriever | Annex Medical, Inc. | FFL | Class II | |
| K910484 | Antimicrobial Susceptibility Test Panel | Alamar | JWY | Class II | |
| K910431 | Hemocard Control | Isolab, Inc. | JCM | Class II | |
| K910147 | Creatinine Reagent(creat), Cat.# Re0015/modified | Olympus Corp. | CGX | Class II | |
| K910085 | Abuscreen Online Cannabinoids Calibrators | Roche Diagnostic Systems, Inc. | DKB | Class II | |
| K905775 | Siemens Etco2 Cartridge | Siemens Medical Electronics | CCK | Class II | |
| K905683 | Biotrol Lactate Dehydrogenase (L-P) | Biotrol, USA, Inc. | CFJ | Class II | |
| K905596 | Neuromed Octrode Model Mnr-88B/88c Neurostim Syst | Neuromed, Inc. | GZB | Class II | |
| K905543 | Lares Apollo Cs/cp/c | Lares Research | EBZ | Class II | |
| K905542 | Lares Apollo Cs and S Handpiece Lighting Systems | Lares Research | EFB | Class I | |
| K905496 | Woven and Knitted Minicrimp Carotid Patch Fabrics | Meadox Medicals, Div. Boston Scientific Corp. | DXZ | Class II | |
| K905402 | Antigenz Chlamydia | Northumbria Biologicals, Ltd. | GZB | Class II | |
| K905227 | Glucose (Hk) Reagent, Universal | Enzyme Technology, Inc. | CFR | Class II | |
| K904031 | Chema Chol Cholesterol System | Texas Intl. Laboratories, Inc. | CHH | Class I | |
| K910471 | Medid-Vac Clear Nonconductive Connecting Tube | Baxter Healthcare Corporation | GAZ | Class II | |
| K910417 | Evidence Biological Indicator | Skyland Scientific Services, Inc. | FRC | Class II | |
| K910303 | Sysnpar Porcelain | Jeneric/Pentron, Inc. | ELL | Class II | |
| K910028 | Post Auricular Hearing Aid Model Pico Sc-H | Phonak, Inc. | ESD | Class I | |
| K905755 | Non-Sterile Patient Examination Gloves | Superior Healthcare Group, Inc. | LYY | Class I | |
| K905696 | Stratofuse Pca Infuser | Strato Medical Corp. | FRN | Class II | |
| K905680 | 543 Series Bte | Hearing Tech, Inc. | ESD | Class I | |
| K905603 | Philips Gyroview-Hr Imaging Workstation | Philips North America LLC | LNH | Class II | |
| K905557 | Ccc Crown-Core-Cut-Needle | Uni-Quatro Industries Canada, Inc. | KNW | Class II | |
| K905556 | High Speed Core Cut Biopsy Gun | Uni-Quatro Industries Canada, Inc. | FCG | Class II | |
| K904697 | Patient Examination Gloves | Shamrock Marketing Co., Inc. | LYY | Class I | |
| K901975 | Ipazyme(tm) Chlamydia True Igm(tm) | Savyon Diagnostics Ltd. | LKH | Class I | |
| K910820 | Vpw 2877E6 X-Ray Power Supply | Varian Canada, Inc. | IZO | Class I | |
| K910819 | Companion Speech Aid, Model 160 | Companion Products Intl. | ILQ | Class II | |
| K910796 | Companion Speech Aid, Model 432 | Companion Products Intl. | ILQ | Class II | |
| K910775 | Jm Gloves Sterile Vinyl Examination | Jm Gloves Co., Ltd. | LYZ | Class I | |
| K910774 | Am Gloves Sterile Vinyl Examination | Am Gloves Co., Ltd. | LYZ | Class I | |
| K910660 | Boston(r) Brand Latex Exam Gloves/hypoallergenic | Boston Medical Corp. | LYY | Class I | |
| K910631 | Suntex Sterile Exam Gloves | P.T. Latexindo Prautama | LYY | Class I | |
| K910586 | Auto Suture(r) Polymer Skin Graft Stapler* | United States Surgical, A Division of Tyco Healthc | GDT | Class I | |
| K905748 | Mamex Dc Ami Sl12/mg15 | Soredex, Inc. | IZH | Class II | |
| K905739 | Zimmer Ceramic Femoral Heads | Zimmer GmbH | LZO | Class II | |
| K905631 | Comprinet, Comtesse and Bellavar Stockings | Jobst Institute, Inc. | DWL | Class II | |
| K905541 | Lares 757 Workhorse Highspeed Handpiece | Lares Research | EFB | Class I | |
| K905512 | Anterior Neck Contour Coil | Magnetic Research, Inc. | LNH | Class II | |
| K904970 | Body Composition Analyzer | Body Composition Analog, Inc. | DSB | Class II | |
| K904878 | Sensi Rads Lead Latex Radiation Prot. Glove, Ster. | Hpi, Inc. | IWP | Class I | |
| K903648 | Vygon Lifevac Picc | Vygon Corp. | LJS | Class II | |
| K902588 | Bsm/21&22 Sc Blood Safe Mod & V.p.m. Ven Press Mod | Gambro-Hospal, Inc. | KOC | Class II | |
| K901883 | Stereotactic One Medical Application Software | Stereotactic Image Systems, Inc. | HAW | Class II | |
| K901146 | Joslyn Eo Sterilizer/ Eo Modernization Kit | Joslyn Valve Corp. | FLF | Class II | |
| K910842 | Di2000/hs-45-150 X-Ray Tube Insert | Comet Ltd. C/O Radiology Resources, Inc. | ITY | Class I | |
| K910554 | Clinak(tm) Ise Subsystem | Baxter Healthcare Corporation | JGS | Class II | |
| K910343 | Ciba Corning Acs Vitamin B12 Immunoassay | Ciba Corning Diagnostics Corp. | CDD | Class II | |
| K910328 | Key Comfort Grips | Key Surgical, LLC | FSM | Class I | |
| K910276 | X-Ray Tube Housing Assembly Soredex Dc/cir 51 | Inmark Corp. | ITY | Class I |