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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K780865 | Magnetic Drape - Instrument Holder | Devon Industries, Inc. | KKX | Class II | |
| K780863 | Model 65 High & Low Pressure Alarm | The John Bunn Co. | CAP | Class II | |
| K780548 | Disposa-Loops | Medi-Spec | KKX | Class II | |
| K781293 | Restorative System Profile | The S. S. White Co. | EBF | Class II | |
| K781110 | Bandage, Compression, Fistulaid | Medical Device Laboratories | DJC | Class II | |
| K781088 | Ostomy Appliance Belt | E. R. Squibb & Sons, Inc. | EXB | Class I | |
| K781047 | Drape, Surgical-Spartan Limb Sheet | Spartan Healthcare Products Co. | KKX | Class II | |
| K781046 | Impervious Stockinet | Spartan Healthcare Products Co. | KKX | Class II | |
| K781334 | Disposable Syringe Fill Tube | Mallinckrodt Group, Inc. | DXT | Class II | |
| K781331 | A-V Fistula Needle | BD Becton Dickinson Vacutainer Systems Preanalytic | DJC | Class II | |
| K781322 | Sterile Wet Dressing Pack | W.G. Whitney Corp. | EFQ | Unclassified | |
| K781240 | Enzymatic Triglycerides Reagent Kit | J.T. Baker Chemical Co. | CDT | Class I | |
| K781134 | Catheter, Thermal Dilution Fiberoptic | Oximetrix, Inc. | DQE | Class II | |
| K781011 | K-Z Concentrate | K-Zyme Labs, Inc. | EXB | Class I | |
| K780992 | Millard Mouth Gag | Nestor Engineering Associates, Inc. | KBN | Class I | |
| K781339 | Endotracheal Tube | Life-Line Products, Inc. | BTR | Class II | |
| K781302 | Neurostat, Lloyd | Spembly Medical, Ltd. | GXH | Class II | |
| K781365 | Sparta Bronchial Brush | Sparta Instrument Corp. | KTI | Class II | |
| K781363 | Cast Shoe | Cutler Biomedical | IPG | Class I | |
| K781304 | Transport Media | BD Becton Dickinson Vacutainer Systems Preanalytic | JSN | Class I | |
| K781294 | Prosthesis, Knee, Total | Zimmer GmbH | JWH | Class II | |
| K781285 | Insulin Ria Kit | Serono Laboratories, Inc. | CFP | Class I | |
| K781283 | Reader, Inoculum, Stdized. | Analytical Products, Inc. | |||
| K781268 | Chair, Vestibular, Rotary, Comput. | Contraves | LXV | Unclassified | |
| K781260 | Ventilation Tube Silicone Paparella Type | Xomed, Inc. | ETD | Class II | |
| K781259 | Ventilation Tube Teflon Shepard Type | Xomed, Inc. | ETD | Class II | |
| K781258 | Ventilation Tube. Sili. Donaldson Type | Xomed, Inc. | ETD | Class II | |
| K781257 | Ventilation Tube Sili. Sheppard Type | Xomed, Inc. | ETD | Class II | |
| K781241 | Unistat Bilirubinometer | American Optical Corp. | JJQ | Class I | |
| K781235 | IV Vitro Gammadab T4 Ria Kit | Clinical Assays, Inc. | CDX | Class II | |
| K781233 | IV Armboards | Fibre Formations, Inc. | BTX | Class I | |
| K781212 | Hearing Aid, Model 783Du | Danavox, Inc. | ESD | Class I | |
| K781209 | Monitor, Oxygen, Model 3000A | Oxyair Engineering, Inc. | CCL | Class II | |
| K781182 | Micro Thyroxine Reagent System | BD Becton Dickinson Vacutainer Systems Preanalytic | CDX | Class II | |
| K781181 | Cliniria Total T-4 (Ria) Test | Miles Laboratories, Inc. | CDX | Class II | |
| K781180 | Cliniria T-3 Uptake Test | Miles Laboratories, Inc. | KHQ | Class II | |
| K781170 | Quantimune Htsh Irma Human Thyroid | Bio-Rad | JLW | Class II | |
| K781149 | Cpk-L Tube | BD Becton Dickinson Vacutainer Systems Preanalytic | CGS | Class II | |
| K781143 | Immunofluorescence Test Kit | Microbiological Assoc. | |||
| K781138 | Spectrophotometer | Bausch & Lomb Incorporated | JJQ | Class I | |
| K781135 | Ingrown Toenail Appliance, or | Barmore, Barbara | |||
| K781133 | Pc-Calibrator | Streck Laboratories, Inc. | KRY | Class II | |
| K781121 | Hemolyse | Electrophoresis Corp. of America | GGK | Class I | |
| K781119 | Eca Heme Buffer | Electrophoresis Corp. of America | JBD | Class II | |
| K781114 | Ultramate 990 | Litton Dental Products | EIA | Class I | |
| K781100 | Delta Test Amylase/lipase Conts. i,ii | BD Becton Dickinson Vacutainer Systems Preanalytic | JJT | Class I | |
| K781099 | Surgical Gowns and Drapes | Convertors | FYA | Class II | |
| K781097 | Inoculum Stdizing Sys., Inocupac | 3M Company | |||
| K781093 | Hdl Centrifikit | Beckman Instruments, Inc. | LBR | Class I | |
| K781086 | Insulin Autopak | Micromedic Systems | CFP | Class I |