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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K813324 | Bodai Swivel Y | Sontek Industries, Inc. | BSY | Class I | |
| K813323 | Thigh Cuff: X-Large Cuff | Abco Dealers, Inc. | DXQ | Class II | |
| K813308 | Double Seal Tubeguaze Sterile Bandage | Scholl, Inc. | NAB | Class I | |
| K813296 | Convertors Sterile Disp. Lap Sponge II | American Convertors Div., American Pharmaseal | EFQ | Unclassified | |
| K813284 | Venous Cannula Tray | Cunningham Woodland, Inc. | DWS | Class I | |
| K813271 | Temperature Probes | Webster Laboratories, Inc. | KRI | Class I | |
| K813245 | O'connor Hook Punch Forcep | Shutt Instruments | GEN | Class I | |
| K813230 | Afterloading Gynecological Applicator | Esi | IWJ | Class I | |
| K813222 | Model 4200 Ellestad Stress Test Analyzer | Del Mar Avionics | DXG | Class II | |
| K813217 | Digital Flurographic Imaging System | Diasonics, Inc. | JAA | Class II | |
| K813196 | Image Analysis Center | Technicare Corp. | JAK | Class II | |
| K813195 | Medifix Graduated Scale | Burron Medical Products, Inc. | KRK | Class II | |
| K813176 | Gel Electrode | Dyn-A-Med Products | DRX | Class II | |
| K813163 | Suction Catheter | Northern Medical Industries | BSY | Class I | |
| K813081 | Histocan Biopsy Needle | Burron Medical Products, Inc. | |||
| K813064 | Telemetry Transmitter & Receiver | Honeywell, Inc. | DRG | Class II | |
| K812971 | Cardiointegram | Ocg Technology, Inc. | DXG | Class II | |
| K812955 | East Water Unit Mark 3 | Cairco, Ltd. | DWJ | Class II | |
| K812914 | Micro-Preprocessor Unit | General Electric Co. | DSI | Class II | |
| K812851 | Sbp-16 Clinic Muscle Stimulator | Southwestern Bio-Physical Corp. | IPF | Class II | |
| K812739 | Vitalog Pms-8 Monitor | Vitalog Corp. | DQK | Class II | |
| K812586 | Kantron 504 Heartstation | Kantron Cardiovascular, Inc. | LDD | Class II | |
| K813484 | Progesterone Kit by Ria | Immuchem Corp. | JLS | Class I | |
| K813478 | Triglyceride Calibrators | Gilford Diagnostics | JIS | Class II | |
| K813426 | Multiwash | Flow Laboratories, Inc. | JQW | Class I | |
| K813406 | Cpk(ck) in Vitro Diag. Reagent Set | Horiba Instruments Incorporated | JHS | Class II | |
| K813405 | Ast(sgot) in Vitro Diag. Reagent Set | Horiba Instruments Incorporated | CIT | Class II | |
| K813401 | Coat-a-Count Testosterone Ria Kit | Siemens Healthcare Diagnostics Inc. | CDZ | Class I | |
| K813400 | Inorganic Phosphorus Reagent Set | Anco Medical Reagents & Assoc. | CEO | Class I | |
| K813392 | Radioimmunoassay for Human Thyroid | Leeco Diagnostics, Inc. | JLW | Class II | |
| K813373 | Vygon Endotracheal Tubes | Exco, Inc. | BTR | Class II | |
| K813370 | Electrolyte Gel | Hi Chem, Inc. | CGA | Class II | |
| K813369 | Gram Stain Reagents and Kit | BD Becton Dickinson Vacutainer Systems Preanalytic | JTS | Class I | |
| K813366 | Ammonia Test | Wako Pure Chemical Industries, Ltd. | JID | Class I | |
| K813349 | Bi-Level Acetaminophen-Salicylate Cnrl | Stanbio Laboratory | DIF | Class I | |
| K813326 | Trocki Body Ventrilator | L.T.D. 3 Co. | BYT | Class II | |
| K813213 | Sharia-Lh Ria Kit for Quantitation Hormo | Intl. Immunoassay Laboratories, Inc. | CEP | Class I | |
| K812987 | Agglutex Methaqualone Test Kit | Hoffmann-La Roche, Inc. | KXS | Class II | |
| K813440 | Philly Bolt | Philadelphia Medical Specialties | GWM | Class II | |
| K813435 | Baxa Adli Seal | Baxa Corp., Sub. of Cook Group, Inc. | KPE | Class II | |
| K813424 | Thermometers | Abco Dealers, Inc. | FLK | Class II | |
| K813423 | Thermometer Sheaths | Abco Dealers, Inc. | FLK | Class II | |
| K813421 | Non-Adher Pads | Abco Dealers, Inc. | KGX | Class I | |
| K813411 | Document Linearity Test Standards | North American Standards | JIX | Class II | |
| K813409 | Model 2100 Dual-Display Tele-Thermometer | Yellow Springs Instrument Co., Inc. | FLL | Class II | |
| K813391 | Tobramycin Reagent Test Kit | Beckman Instruments, Inc. | LKB | Unclassified | |
| K813341 | Wound-Evac | Heritage Medical Products, Inc | GCY | Class I | |
| K813339 | Direct Fa Conjugate for Legionella Sp | Springwood Microbiologicals | LHL | Class II | |
| K813336 | Lazarus-Nelson Peritoneal Lavage Tray | American Pharmaseal Div. Ahsc | FKO | Class II | |
| K813278 | Vpi Ureteral Dilatation Ballon Catheter | Vance Products, Inc. | EZN | Class II |