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 |
|---|---|---|---|---|---|
| K910770 | 504Us Pulse Oximeter | Criticare Systems, Inc. | DQA | Class II | |
| K910629 | Ap-860Pa Nibp Module | Nihon Kohden America Inc | DQA | Class II | |
| K910601 | Pathfinder | Nurion Industries | HPG | Class I | |
| K910142 | Spark Kit(r), Modification | Lyphomed, Inc. | FPA | Class II | |
| K905397 | Pb3200 Intra-Arterial Blood Gas Monitoring System | Medtronic, Inc. | CCE | Class II | |
| K904889 | TENS Conductive Media Pad | Creative Design Systems, Inc. | GYB | Class II | |
| K902607 | Dantec Magnetic Stimulator Mag 2 (Mag 2) | Dantec Medical, Inc. | GWF | Class II | |
| K911921 | Disposable Isolation Gown | Liaoning-Usa Corp. | FYB | Class II | |
| K911913 | Precision Glide - Enhanced Surgical Blade | BD Becton Dickinson Vacutainer Systems Preanalytic | GES | Class I | |
| K911369 | Qualtex Light Handle and Light Handle Cover | DeRoyal Industries, Inc. | MDM | Class I | |
| K911108 | Ophta Sil (R), Punctal Plugs and Inserters | G.W.B. Intl., Ltd. | LZU | Unclassified | |
| K911039 | Invotec Ear Drape | Invotec International, Inc. | KKX | Class II | |
| K910907 | Pump Vac Plus | Marlo Surgical Technology | HET | Class II | |
| K910662 | Ps Omnifit Normalized Hip Stem Series | Osteonics Corp. | JDI | Class II | |
| K910637 | Mentor(r) Sur-E-Trol(r) | Mentor O & O, Inc. | FRN | Class II | |
| K910587 | Miniscope | Citation Medical Corp. | HRX | Class II | |
| K910281 | Intravascular Imaging System/modified | Intertherapy, Inc. | JOP | Class II | |
| K910194 | Companion 318 Nasal CPAP Diagnostics System | Medtronic, Inc. | BZD | Class II | |
| K905404 | Medtronic Sullivan Nasal CPAP System | Medtronic, Inc. | BZD | Class II | |
| K904430 | Mens Freedom Micro | Monad Corp. | GZJ | Class II | |
| K904288 | Mens-O-Matic 1Xs and Mens-O-Matic 2Xs | Monad Corp. | GZJ | Class II | |
| K904260 | Mens-O-Matic 3000 | Monad Corp. | GZJ | Class II | |
| K904258 | Micro Derm | Monad Corp. | GZJ | Class II | |
| K904235 | Mens-O-Matic 2000 | Monad Corp. | GZJ | Class II | |
| K904234 | Mens-O-Matic I | Monad Corp. | GZJ | Class II | |
| K900576 | Modified Aerochamber with Mask | Monaghan Medical Corp. | CCQ | Class I | |
| K911145 | Borrelia Burgdorferi Polyval Igg/igm Antibody Test | Medical Diagnostic Technologies, Inc. | LSR | Class II | |
| K910671 | Model Gs-4700 Common Duct Stone Removing Kit | Solos Endoscopy, Inc. | FGE | Class II | |
| K910646 | Superserum Reagent (Ssr) | Accriva Diagnostics, Inc. | JKA | Class II | |
| K910440 | Document Reflectance II Linearity Test Set | Casco Standards | JJY | Class I | |
| K910181 | Hitt by Hemochron(r) | Accriva Diagnostics, Inc. | KFF | Class II | |
| K910180 | Bacti-Swab | Remel Inc | JSM | Class I | |
| K905590 | Ucez - Sterile Lens Fog Reduction Device | Inman Liebelt Corp. | OCT | Class II | |
| K911900 | Raichem Spia C3 Reagent | Reagents Applications, Inc. | CZW | Class II | |
| K911899 | Raichem Spia C4 Reagent | Reagents Applications, Inc. | DBI | Class II | |
| K911633 | Perry(r) Encore Chemotherapy Glove | Smith & Nephew Perry | LYY | Class I | |
| K911387 | CT Sytec 4000 | GE Healthcare | JAK | Class II | |
| K911275 | Posicam System Model 6.5 Posicam-Hz System | Positron | KPS | Class II | |
| K911182 | Nnhs 2050 Series (2055W-2054Pp) Hearing Aids | Magnatone Hearing Aid Corp. | ESD | Class I | |
| K911174 | Nhs 2009Sp Hearing Aid | Magnatone Hearing Aid Corp. | ESD | Class I | |
| K910941 | Lifeliner Surgical Glove | Depuy-Raynham | FYE | Class I | |
| K910802 | Power Scan 1000 | Webb Research, Inc. | LNH | Class II | |
| K910788 | Cmi Tender Touch Ve #303Tt and 404Tt | Challenge Mfg., Inc. | HIS | Class II | |
| K910663 | Bovie Model X-10, X-10I, Electrosurgical Generator | Mdt Corp., Inc. | GEI | Class II | |
| K910577 | Edwards-Wallace Bourne Hall Catheter | Marlo Surgical Technology | MFD | Class II | |
| K910518 | Glove-N-Gel Amniotomy Kit | Epcom Medical Systems, Inc. | HGE | Class I | |
| K910200 | Laser-35 | Endo Technic Corp. | GEX | Class II | |
| K905471 | Trocar Access Sheath | Cook Ob/Gyn | HET | Class II | |
| K904264 | Model Sw-103 Solitans Stimulator | Medical Consultants Intl., Ltd. | GZJ | Class II | |
| K904237 | Rapid Immobilization Device or R.i.d. System | Innovative Medical Technologies, Inc | FPP | Class I |