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 |
|---|---|---|---|---|---|
| K840841 | Reneau Unit | Reneau, Inc. | CBF | Class II | |
| K842355 | Infusaid Infuse-a-Port | Infusaid Corp. | LJT | Class II | |
| K841968 | Deseret Disposable Pressure Transducer | Parke-Davis Co. | DRS | Class II | |
| K841633 | Neos Lp | Biotronik Sales, Inc. | DXY | Class III | |
| K843051 | Wrights Stain Solution | Reagent Laboratory, Inc. | |||
| K842956 | Nicolet Viking | Nicolet Biomedical Instruments | IKN | Class II | |
| K842941 | Multiple Planetamed;planeta Hydromass | Planeta Hausgeraete KG | ILJ | Class II | |
| K842872 | Indole Reagent | Irvine Diagnostic Services | JSF | Class I | |
| K842870 | Voges-Proskauer Reagent a | Irvine Diagnostic Services | JSF | Class I | |
| K842868 | Hippurate Test Disks | Irvine Diagnostic Services | JSF | Class I | |
| K842867 | Voges-Proskauer Reagent B | Irvine Diagnostic Services | JSF | Class I | |
| K842855 | Christensen's Urea Agar | Anarobe Systems | JSF | Class I | |
| K842853 | Lysine Iron Agar | Anarobe Systems | JSF | Class I | |
| K842852 | Brain Heart Infusion Broth | Anarobe Systems | JSC | Class I | |
| K842849 | Trypticase Soy Broth | Anarobe Systems | JSC | Class I | |
| K842780 | Medtronic 6210 Permanent Lead Introduc | Medtronic, Inc. | DYB | Class II | |
| K842732 | Zenkers Solution | E K Ind., Inc. | IFH | Class I | |
| K842730 | Gentian Violet | E K Ind., Inc. | ICF | Class I | |
| K842729 | Decolorizing Fluid | E K Ind., Inc. | PPM | Class I | |
| K842728 | Buf-Fix | E K Ind., Inc. | IFP | Class I | |
| K842727 | Supermount | E K Ind., Inc. | LED | Class I | |
| K842726 | Decalcifier Solution | E K Ind., Inc. | KDX | Class I | |
| K842725 | Saline, 0.85%W/preservative | E K Ind., Inc. | KIP | Class I | |
| K842724 | Saline 0.85% W/o Preservative | E K Ind., Inc. | KIP | Class I | |
| K842723 | Saline, 1.3% W/o Preservative | E K Ind., Inc. | KIP | Class I | |
| K842721 | Limonene | E K Ind., Inc. | KEM | Class I | |
| K842709 | Immustaph Latex Agglutination Kit | Immucell Corp. | LHJ | Class I | |
| K842581 | Cavi-Med | Cooper Lasersonics, Inc. | ELC | Class II | |
| K842328 | Amer. Histo-Id Sys Primary Lambda Chain | Bartels Immunodiagnostic Supplies, Inc. | DEH | Class II | |
| K842321 | Air Shields As461 Monitoring Sys | Air-Shields, Inc. | DRT | Class II | |
| K842141 | Solution Clarification Unit | Pall Biomedical Products Co. | KRJ | Class II | |
| K842138 | Cobe Emergency Power Source 43610-000 | Cobe Laboratories, Inc. | DTQ | Class II | |
| K842050 | Impact Model 316 | ZOLL Medical Corporation | JCX | Class II | |
| K842007 | Centrimed System 1 | Centrimed Corp. | KFM | Class II | |
| K842005 | Model 110-5 & 140-8 | Camino Laboratories, Inc. | DXO | Class II | |
| K841940 | Van-Tec Ureteral Dilation Balloon Cath | Van-Tec, Inc. | EZN | Class II | |
| K841938 | Cardioplegia Reservoir Cas-2000 | American Bentley | DTN | Class II | |
| K841885 | Fastpass Implantable Endocardial Pac | Pacesetter Systems | DTD | Class II | |
| K841739 | Model 866 Permathane Bipolar, Coaxial | Pacesetter Systems | DTD | Class II | |
| K841635 | Leptos | Biotronik Sales, Inc. | DXY | Class III | |
| K841521 | Scanlan Endarsector | Scanlan Intl., Inc. | DWX | Class II | |
| K841476 | Tubular Hollow Fiber Membrane | American Bentley | DTZ | Class II | |
| K841201 | Porous Hydroxyapatite Bg200 | Interpore Intl. | LYC | Class II | |
| K840748 | Lithium Pacemaker 811-811L & 811Xl | Omikron Scientific, Ltd. | DXY | Class III | |
| K840440 | Electrocardiograph E-340 | Burdick Corp. | DPS | Class II | |
| K840198 | Arterial Embolectomy Catheter | Shiley, Inc. | DXE | Class II | |
| K834382 | Pall Ec Plus Filter W/filter Sleeve | Pall Biomedical Products Co. | DTM | Class II | |
| K834380 | Pall Ec Plus Filter | Pall Biomedical Products Co. | DTM | Class II | |
| K842987 | Apollo Air Fluidized Bed | Apollo Fluid Dynamics | INX | Class II | |
| K842824 | Chermel Bone Chisels | Cher Mel Corp. | KDG | Class I |