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 |
|---|---|---|---|---|---|
| K801267 | Red Blood Cell Count & Hematocrit Cntl | Bioscientific | JPK | Class II | |
| K801265 | White Blood Cell Count Control Levels | Bioscientific | JPK | Class II | |
| K801239 | Sterile, Disp Dome, Individ. Pkg. | Pacific Domes, Inc. | DRS | Class II | |
| K801211 | Cobe Hemoflo Blood Tubing Sets | Cobe Laboratories, Inc. | FJK | Class II | |
| K801138 | Model P-380 Physiological Pressure Tran. | Gics Pharmaceuticals | DRS | Class II | |
| K800957 | Douche Unit-1500 Ml Disp. Container | The Healthcare Group Laboratories, Inc. | HED | Class I | |
| K800787 | Antibody to Varicella-Zoster Virus | Electro-Nucleonics Laboratories, Inc. | GGW | Class II | |
| K800627 | Ambulatory Infusion Pump, Code 2M9807 | Travenol Laboratories, S.A. | FRN | Class II | |
| K800624 | Low-Acetate Hemodialysis Bath Concentr. | Travenol Laboratories, S.A. | KPO | Class II | |
| K801515 | Abby II Patient Monitor or Vital Signs M | Abbott Medical Electronics Co. | DRT | Class II | |
| K801485 | Series 602 Ckg Recorder (Modified) | Cardio Kinetics, Inc. | DSF | Class I | |
| K801476 | Application of Emit Theophylline Assay | Syva Co. | KLS | Class II | |
| K801475 | Application of Emit AED Assays | Syva Co. | KLI | Class II | |
| K801434 | J.t. Baker Transferrin Nephelometric Ass | J.T. Baker Chemical Co. | DDG | Class II | |
| K801433 | Haptoglobin Nephelometric Assay | J.T. Baker Chemical Co. | DAD | Class II | |
| K801432 | Hemopexin Nephelometric Assay | J.T. Baker Chemical Co. | CZX | Class II | |
| K801430 | Control Syringe | Abco Dealers, Inc. | FMF | Class II | |
| K801422 | Sandare Lyophilized Glycohemoglobin Cls. | Sandare Chemical Co., Inc. | LCP | Class II | |
| K801413 | Amerlex Digoxin Ria Kit | Amersham Corp. | LCS | Class II | |
| K801384 | Myelostat Dorsal Cord Stimulator, Etc. | Medtronic, Inc. | GZB | Class II | |
| K801380 | Crown Delta Silicone Impression Material | Crown Delta Corp. | ELW | Class II | |
| K801356 | Bionics Bi-Flo Safe(double Lumen Cathet | Cordis US Corp. | KOC | Class II | |
| K801355 | Bionics Bi-Flo Stretch(double Lumen for | Cordis US Corp. | KOC | Class II | |
| K801354 | Bionics Arterial/venous Fistula Needle | Cordis US Corp. | KOC | Class II | |
| K801352 | Hemorrhoidal Ligation Instr. System | Depuy, Inc. | FHN | Class II | |
| K801345 | Kampner Hinged Toe Prosthesis | Biomedics | KWH | Class II | |
| K801342 | Disposable Articulator | Williams Gold Refining Co., Inc. | EJP | Class I | |
| K801335 | Unassayed Chemistry Serum Control(bovine | Warner-Lambert Co. | JJY | Class I | |
| K801300 | Dupont 'Aca' Conjugated Bilirubin(cbil) | E.I. Dupont de Nemours & Co., Inc. | JIW | Class II | |
| K801298 | Cobas Reagent for Triglycerides & Cobas | Roche Analytical Instruments, Inc. | CDT | Class I | |
| K801295 | Cobas Reagent for a-Amylase | Roche Analytical Instruments, Inc. | JFJ | Class II | |
| K801291 | Ec-4 Plethysmograph | D. E. Hokanson, Inc. | JOM | Class II | |
| K801286 | Porta-Neb(r) 310 | E.B.E. Research & Mfg., Inc. | BTI | Class II | |
| K801270 | Test for Ketone in Urine(acetoacetic Ac | Miles Laboratories, Inc. | JIN | Class I | |
| K801269 | Seralyzer Blood Urea Nitrogen(bun) | Miles Laboratories, Inc. | JGZ | Class II | |
| K801236 | Reigning Epoxy Resin Cement | Oki Shiks USA, Ltd. | EMA | Class II | |
| K801177 | Aso Quantum, Antistreptolysin O Test | Sclavo, Inc. | GTQ | Class I | |
| K801168 | Collimax X-Ray Collimator # R-182 | Ito X-Ray Corp. | IZX | Class II | |
| K801106 | Multicor (Gamma) Model 336 & Model 337 | Cordis US Corp. | DXY | Class III | |
| K801038 | Adaptaid Elema Lead Adapter Kit 365-17 | Intermedics, Inc. | DTD | Class II | |
| K801020 | Gamma Prolactin Radioimmunoassay Kit- | Travenol Laboratories, S.A. | CFT | Class I | |
| K801011 | Avl #980 Electrolyte Analyzer | Gauntlet Technology Corp. | JGS | Class II | |
| K800816 | Hippur-Ase Tubes | Microchemical Specialities, Co. | JTO | Class I | |
| K800803 | Nitrate Swab-Rapid Test | Remel Co. | JXB | Class I | |
| K800768 | Vasculab Bi-Directional Doppler, #D10 | Medasonics, Inc. | JAF | Class II | |
| K801405 | Disposable Perfusion Connectors | Texas Medical Products, Inc. | DTL | Class II | |
| K801404 | Disposable Parallel Y Connectors | Texas Medical Products, Inc. | DTL | Class II | |
| K801403 | Disposable Perfusion Set | Texas Medical Products, Inc. | DWF | Class II | |
| K801402 | Quickie Prime Cardiop. Bypass Perf. Intr | Texas Medical Products, Inc. | DTL | Class II | |
| K801401 | Cardiopulmonary Bypass Tubing | Texas Medical Products, Inc. | DWF | Class II |