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 |
|---|---|---|---|---|---|
| K812502 | Implantaid Lead Introducer #319-10 & 12 | Intermedics, Inc. | DYB | Class II | |
| K812461 | Tandem Qualitative Hcg Kit | Hybritech, Inc. | JHI | Class II | |
| K812446 | Sunlamp | The Richmond Light Co. | FTC | Class II | |
| K812393 | 4001 CT Scanner | Omnimedical | JAK | Class II | |
| K812304 | Dorros-Spring Pressurizer | Cardiovascular Diagnostic Services | MAV | Class II | |
| K812281 | Touchless Home-Cath | Diamed Division Ill. Tool Works, Inc. | KOD | Class II | |
| K812218 | Kalos-03 | Biotronik Sales, Inc. | DXY | Class III | |
| K812206 | Laparoscope | Reznik Instruments | HET | Class II | |
| K812204 | Uterine Manipulators | Reznik Instruments | KOH | Class I | |
| K812203 | Electrosurgical Unit | Reznik Instruments | GEI | Class II | |
| K812199 | Trocar & Trocar Sleeves | Reznik Instruments | HET | Class II | |
| K811593 | Atrial Endocardial Electrode Lead of J | Telectronics, Inc. | DTB | Class III | |
| K812836 | Ldh Reagent Set | Anco Medical Reagents & Assoc. | CFH | Class II | |
| K812835 | Total Calcium Reagent Set | Anco Medical Reagents & Assoc. | CIC | Class II | |
| K812560 | Mdm Arterial Blood Gas Syringe | Martell Medical Products, Inc. | FMF | Class II | |
| K812697 | Hema 20 Micron Transfusion Blood Filter | Abbott Medical | CAK | Class II | |
| K812684 | Adult Flexfloat | Pharmaquest Corp. | FOH | Class I | |
| K812682 | Flexfloat Heater | Pharmaquest Corp. | FOH | Class I | |
| K812681 | Adult Flex Float W/heater | Pharmaquest Corp. | FOH | Class I | |
| K812672 | Self-Centering Hip | Depuy, Inc. | KWY | Class II | |
| K812656 | Dotrich Electronic Air Cleaner #C500am | Leedal, Inc. | FRF | Class II | |
| K812629 | Aca Fibrinogen Test Pack | E.I. Dupont de Nemours & Co., Inc. | KQJ | Class II | |
| K812627 | Aca Antithrombin III Test Pack | E.I. Dupont de Nemours & Co., Inc. | JBQ | Class II | |
| K812619 | Isolated Voltage/frequency Converter | Bio-Feedback Systems, Inc. | HCC | Class II | |
| K812579 | Suntanning Home Unit | Tannhut | FTC | Class II | |
| K812543 | Tanarama | Marketing Consultants of America | FTC | Class II | |
| K812426 | Uterine Aspiration Curettes(rigid&flex) | Medi-Spec | HHK | Class II | |
| K812155 | Medtronic Dual Channel Spinal Cord Stim | Medtronic, Inc. | GZB | Class II | |
| K812719 | Prosana Belt | Bandwagon, Inc. | IQE | Class I | |
| K812699 | Amylase | Horiba Instruments Incorporated | KHM | Class II | |
| K812698 | Gc Disk | Remel Co. | JTR | Class I | |
| K812690 | C-Peptide Control Pack | Mallinckrodt Critical Care | JJX | Class I | |
| K812689 | Ria Quant C-Peptide Kit | Mallinckrodt Critical Care | JKD | Class I | |
| K812680 | G-C Impression Syringe | G-C Intl. Corp. | EID | Class I | |
| K812679 | G-C Fit-Checker Impression Material | G-C Intl. Corp. | ELW | Class II | |
| K812587 | Mono 2 Oxygen Monitor | Kantron Cardiovascular, Inc. | CCL | Class II | |
| K812571 | Mezlocillin 75 Mcg. Sensi-Disc | BD Becton Dickinson Vacutainer Systems Preanalytic | JTN | Class II | |
| K812441 | Di-Crown | Coburn Optical Ind., Inc. | HQG | Class I | |
| K812406 | Exaflex Impression Material | G-C Intl. Corp. | ELW | Class II | |
| K812245 | Intermedics Poly Flex Endocardial Atrial | Intermedics, Inc. | DTB | Class III | |
| K812221 | Intermedics Poly Flex Epicardial Suture | Intermedics, Inc. | DTB | Class III | |
| K812073 | Deseret Catheter Dressing | Warner-Lambert Co. | KGX | Class I | |
| K812052 | Myocath Catolog No. Mck-a | Sorensen Research | |||
| K812176 | Koriclean | Trans World Agency, Inc. | |||
| K812688 | Qi 1150-1T Infusion T | Quinton, Inc. | FPA | Class II | |
| K812687 | Brigham II Total Hip System | Hexcel Medical | JDG | Class II | |
| K812677 | Unitest-Potassium | Biodynamics Corp. | CEJ | Class II | |
| K812671 | Embritrol Ck-Mb Controls | Intl. Immunoassay Laboratories, Inc. | JJT | Class I | |
| K812670 | Sandare Fast 340 Phosphorus Procedure | Sandare Chemical Co., Inc. | CED | Class I | |
| K812669 | Seattle II Total Hip System | Hexcel Medical | JDG | Class II |