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 |
|---|---|---|---|---|---|
| K951283 | R&d Batteries, Inc. Part Numbers 5075-B, 5076, 5122 and 5123 | R & D Batteries, Inc. | FLL | Class II | |
| K951282 | R&d Batteries, Inc. Part Numbers 5039, 5052, 5056 and 5061 | R & D Batteries, Inc. | FLL | Class II | |
| K951281 | R&d Batteris, Inc. Part Number 5024, 5027, 5033 and 5035 | R & D Batteries, Inc. | FLL | Class II | |
| K951280 | R&d Batteries, Inc. Part Numbers 5003, 5006, 5008 and 5012 | R & D Batteries, Inc. | FLL | Class II | |
| K951279 | R&d Batteeries, Inc. Part Numbers 5173, 5178, 5197 and 5199 | R & D Batteries, Inc. | FLL | Class II | |
| K951278 | R&d Batteries, Inc. Part Numbers 5213, 5222, 5268 and 5284 | R & D Batteries, Inc. | FLL | Class II | |
| K951277 | R&d Batteries, Inc. Part Numbers 5295, 5334, 5344 and 5410 | R & D Batteries, Inc. | FLL | Class II | |
| K951276 | R&d Batteries, Inc. Part Numbers 5412, 5420, 5436 and 5438 | R & D Batteries, Inc. | FLL | Class II | |
| K951275 | R&d Batteries, Inc. Part Numbers 5453, 5474, 5513 and 5595 | R & D Batteries, Inc. | FLL | Class II | |
| K951274 | R&d Battries, Inc. Part Numbers 5601, 5602, 5624 and 5626 | R & D Batteries, Inc. | FLL | Class II | |
| K950395 | Thermocool System | Zimmer GmbH | ILO | Class II | |
| K950293 | Tec-2110 Green Laser Model Mt-Hng | Medtec LLC | IWE | Class I | |
| K950012 | Dispomedic Disposable Syringes and Needles | International Regulatory Consultants | FMI | Class II | |
| K950009 | Powergrip(tm) Compression Fixation Device | Synvasive Technology, Inc. | JDW | Class II | |
| K945873 | Hypex(tm) Jet Injector | Equidyne Systems, Inc. | KZE | Class II | |
| K945505 | Acrylic Dipped Latex Surgical Gloves - Sterile | Ganz Industries Sdn. Bhd. | KGO | Class I | |
| K945504 | Acrylic Dipped Latex Examination Gloves - Sterile | Ganz Industries Sdn. Bhd. | LYY | Class I | |
| K936292 | Packaging and Manufacturing Methods Change/knee Components | Howmedica Corp. | LPH | Class II | |
| K934060 | Howmedica(r) Acetabular Comp Pack/manuf Meth Change | Howmedica Corp. | LPH | Class II | |
| K952741 | Triglycerides (Glycerol Blanking) Reagent System | Medical Diagnostic Technologies, Inc. | CDT | Class I | |
| K952345 | Medi-Tech Platform Guide Catheter | Medi-Tech, Inc. | DQY | Class II | |
| K952316 | Nellcor Symphony N-3000 Pulse Oximeter | Nellcor, Inc. | DQA | Class II | |
| K952180 | Cx Lipase Reagent & Calibrator for Synchron Cx Systems | Beckman Instruments, Inc. | CHI | Class I | |
| K952096 | One Step Urine Drug of Abuse Opiate Test (Opium/heroin/morphine) | Tcpi, Inc. | DJG | Class II | |
| K951892 | One Step Urine Drug of Abuse Cocaine Test | Tcpi, Inc. | DIO | Class II | |
| K950882 | Braun Selective Angiographic Catheter | B.Braun Medical, Inc. | DQO | Class II | |
| K950020 | Holter Pacercorder(r) | Del Mar Avionics | DSH | Class II | |
| K945972 | Digital Averaging Tonometer | Opti-Med Electronics | HKX | Class II | |
| K945693 | Cvd Periflow(tm) (Small Vessel) Balloon Dilatation Catheter | Cardiovascular Dynamics, Inc. | LIT | Class II | |
| K953509 | Bipolar Coagulating Forceps | Karl Storz Endoscopy-America, Inc. | GCJ | Class II | |
| K953481 | Nezhat-Dorsey Hydro-Dissection Universal Bagsqueezer | American Hydro-Surgical Instruments, Inc. | GCJ | Class II | |
| K952948 | Saline Dressing | Busse Hospital Disposables | FRO | Unclassified | |
| K952331 | Aoi Lc-40 Phacoemulsifier | Tenex Health | HQC | Class II | |
| K952313 | Varis Images, Including Ximatron Digital Imaging Option | Varian Assoc., Inc. | LLZ | Class II | |
| K951855 | Ultrathin Ureteroscopes | OLYMPUS Corporation of the Americas | FGB | Class II | |
| K950684 | Cynosure Photogenica T10 Tattoo Removal Laser | Cynosure, LLC | GEX | Class II | |
| K950112 | Centralite(r)-Dll Series | Diacor, Inc. | IWE | Class I | |
| K950061 | Hercules Radiation Therapy Couch | Precision Therapy Intl., Inc. | IYE | Class II | |
| K953261 | Chromalex Rheumatoid Factor Latex Test System | Shared Systems, Inc. | DHR | Class II | |
| K953223 | Piperacilin Tazobactam 4 Ug | Ab Biodisk | JWY | Class II | |
| K953107 | Anesthesia/respiratory Face Mask | Medical Marketing Concepts | BSJ | Class I | |
| K953054 | Am 260 Ohm | Electone, Inc. | ESD | Class I | |
| K953053 | Am 260 Pp | Electone, Inc. | ESD | Class I | |
| K953052 | Am 260 K-Amp | Electone, Inc. | ESD | Class I | |
| K953051 | Z35 | Electone, Inc. | ESD | Class I | |
| K953049 | Z24 | Electone, Inc. | ESD | Class I | |
| K953048 | Z22 | Electone, Inc. | ESD | Class I | |
| K953014 | Alastat Microplate Latex-Specific Ige Allergen | Siemens Healthcare Diagnostics Inc. | DHB | Class II | |
| K952649 | Warm-Scale | Olympic Medical Corp. | FRW | Class I | |
| K952396 | Redi Nurse System (Rns) Sterile 0.9% Sodium Chloride Solution | Contour Fabricators of Florida, Inc. | BSY | Class I |