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 |
|---|---|---|---|---|---|
| K833641 | Image Intensifier Tube W/housing & | Varian Assoc., Inc. | JAA | Class II | |
| K833407 | Selecto-Disc Novobiocin 5Ug | Lab Ability, Inc. | JTO | Class I | |
| K833232 | Laser Protective Eyeshield | Stefanovsky & Assoc. | HQF | Class II | |
| K833083 | Derma Strip-Tm Skin Closures | Howmedica Corp. | FPX | Class I | |
| K832965 | Stratus Theophylline Assay | American Dade | KLS | Class II | |
| K831936 | Pre-Rolled Tubular Stockinette | Ormed Mfg., Inc. | |||
| K834306 | Phasix-High Frequency Generator | Cgr Medical Corp. | ITY | Class I | |
| K834288 | Digitilt Ls-30 Remote Control | Elscint, Inc. | IZF | Class II | |
| K834281 | Rad II Simulator | Haynes Radiation Ltd., Inc. | KPQ | Class II | |
| K834279 | Acuray 071A Dental Intraoral X-Ray | Belmont Equipment Corp. | EAP | Class II | |
| K834168 | Fibrinogen Uptake Sys -Various Models | Canberra Industries, Inc. | JZD | Class I | |
| K834144 | Unscented Menstrual Pad | Procter & Gamble Mfg. Co. | HHD | Class I | |
| K834131 | Scented Menstrual Pad | Procter & Gamble Mfg. Co. | HHL | Class II | |
| K834128 | Globe Res-Q-Flo | Globe Safety Equipment, Inc. | |||
| K834089 | Comfit | Ackrad Laboratories | JAY | Class I | |
| K833958 | Flo-Gard 8100 Infusion Pump | Travenol Laboratories, S.A. | FRN | Class II | |
| K833953 | Electronic Gravity 300Vc | Ivent Corp. | LDR | Class II | |
| K833941 | Orion | Cgr Medical Corp. | IYE | Class II | |
| K833932 | Syva Advance Cortisol Assay | Syva Co. | JFT | Class II | |
| K833776 | Qea Sodium/potassium Analyzer | BD Becton Dickinson Vacutainer Systems Preanalytic | CEM | Class II | |
| K833768 | C. Pth Radioimmunoassay Kit-Cpthk | Sorin Biomedica, Fiat, USA, Inc. | CEW | Class II | |
| K833736 | Gold-Palladium-Silver Based Cast/alloy | Jeneric Ind. | EIS | Class I | |
| K833724 | Enzymatic CO2 | American Monitor Corp. | CIL | Class II | |
| K833718 | Etching Gel | Johnson & Johnson Professionals, Inc. | KLE | Class II | |
| K833714 | Respiratory Assessment System | Thoratec Laboratories Corp. | BZL | Class II | |
| K833713 | Serum Thyrotropin Assay Kit, Tipsep- | Nuclear Diagnostics, Inc. | JLW | Class II | |
| K833704 | Amer. V. Mueller Surgicalstaples-Cartr | American Heyer Schulte | GDW | Class II | |
| K833673 | Accurate Measurement Device Ez-Amd | Sorensen Research | GCX | Class II | |
| K833662 | Cardioplegia System Ccs-Xxx Series | Gish Biomedical, Inc. | DTR | Class II | |
| K833655 | Gillette Sabre Syringe | Intermedics, Inc. | FRN | Class II | |
| K833643 | Crystar Porcelain | Shofu Dental Corp. | EIH | Class II | |
| K833598 | Leblond Diamond Dental Bur | A & M Instruments, Inc. | EJL | Class I | |
| K833596 | Gdc 1448 Development Name | Deringer-Ney, Inc. | EJS | Class II | |
| K833536 | Partial Pressure Electrode Measurement | Shaban Mfg. Co. | CHL | Class II | |
| K833535 | Potassium Sodium Analysis Products | Shaban Mfg. Co. | JJO | Class I | |
| K833534 | Partial Pressure Electrode Measurement | Shaban Mfg. Co. | CHL | Class II | |
| K833518 | Blood Oxygenator Heat Exhanger Coating | American Bentley | DTZ | Class II | |
| K833484 | Computed Tomography Oriented Rotary Arc | A. Patil, M.D. | HAW | Class II | |
| K833457 | Ethylene Oxide Gas Steriliza Sys II | Ben Venue Laboratories, Inc. | FLF | Class II | |
| K833434 | Ceramco * High Fusing Foil Solder | Johnson & Johnson Professionals, Inc. | EJS | Class II | |
| K833433 | Physio-Probe-High Permeability Cath. | Research Industries Corp. | DQY | Class II | |
| K833289 | C & B 61 Pentron C & B61 | Genesis Industries, Inc. | EIS | Class I | |
| K833278 | C & B 45 | Genesis Industries, Inc. | EIS | Class I | |
| K833266 | Acra-Cut | Acra Cut, Inc. | HBF | Class II | |
| K833120 | One Time Compound Benzoin Tincture- | Acme United Corp. | KGX | Class I | |
| K833079 | Centracath #130,135 & 137-Hemocath # | Exco, Inc. | FOZ | Class II | |
| K833029 | Flow-Pac Ggt Reagent Set | American Research Products Co. | JQB | Class I | |
| K832802 | Use of Tween 80 as a Wetting Agent on | American Bentley | DTN | Class II | |
| K832284 | Solution Admin. Set 2C9096 W/10 PVC | Travenol Laboratories, S.A. | FPA | Class II | |
| K832005 | Jp-2 Respiratory Monitoring System | Morgan Associates, Inc. | CCK | Class II |