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 |
|---|---|---|---|---|---|
| K812159 | Intravascular Catheter | Pioneer Viggo, Inc. | FOZ | Class II | |
| K812153 | Medtronic Spectrax | Medtronic, Inc. | DXY | Class III | |
| K812149 | Cardio-Data System, #Mark III | Cardio Data | DSI | Class II | |
| K812135 | Barnes-Hind Weekly Cleaner | Barnes-Hind, Inc. | HPX | Unclassified | |
| K812119 | Nimetic-Dispers | Espe-Premier Sales Co. | EBF | Class II | |
| K812118 | Nimetic Polishing Paste | Espe-Premier Sales Co. | EJR | Class I | |
| K812117 | Permagum Adhesive | Espe-Premier Sales Co. | KLE | Class II | |
| K812116 | Permagum | Espe-Premier Sales Co. | KLE | Class II | |
| K812115 | Ketac-Chem | Espe-Premier Sales Co. | EMA | Class II | |
| K812102 | O.n.a.t. | Latex Medical Devices, Inc. | KNT | Class II | |
| K812095 | Enxymatic Creatinine Test | Boehringer Mannheim Corp. | JFY | Class II | |
| K812089 | Polaroid Radiographic Film Cassette | Polaroid Corp. | |||
| K812088 | Polaroid Radiographic Film Processor | Polaroid Corp. | IXW | Class II | |
| K812071 | Rk IV Surgical Blades | Santa Barbara Medco, Inc. | GES | Class I | |
| K812069 | Bores* Depth Gauge | Santa Barbara Medco, Inc. | FTY | Class I | |
| K812026 | K-Med Silicone Sump Drain | K-Med, Inc. | |||
| K812025 | K-Med Silicone Sump Drain W/ Sheath | K-Med, Inc. | |||
| K811999 | Bo Med Bia | Bomed Medical Mfr., Ltd. | DSB | Class II | |
| K811986 | The Amp 80/2 Pediatric Cycler System | American Medical Products LLC | FKX | Class II | |
| K811944 | Gambro Lundia Plate High Flux Dialyzer | Gambro, Inc. | KDI | Class II | |
| K811851 | S-610 Shunt Adaptor Set | Dravon Medical, Inc. | KNR | Class II | |
| K811805 | Trypin (125I) Ria Kit | BD Becton Dickinson Vacutainer Systems Preanalytic | JNO | Class I | |
| K811698 | Carl Zeiss Inn Myringotomy Tube Line | James L. Geraci & Associates, Inc. | ETD | Class II | |
| K810890 | Neoloops | Medical Marketing Systems | DWS | Class I | |
| K812279 | Enter-A1 Enteric Feeding Tube | Medi-Tech, Inc. | KNT | Class II | |
| K812273 | Resuscitation Circuit | Vital Signs, Inc. | BTM | Class II | |
| K812260 | Dyna Trak Endodontic Prep. Instrument | Inventive Technology Int'L., Inc. | EKS | Class I | |
| K812244 | Interface Pre Bypass Prime Filter #90 | Medical, Inc. | KRJ | Class II | |
| K812243 | Interface Cardiotomy Blood Filter #51 | Medical, Inc. | JOD | Class II | |
| K812240 | Interface Pre Bypass Prime Filter | Medical, Inc. | KRJ | Class II | |
| K812233 | Rateminder | Anatros Corp. | LDR | Class II | |
| K812232 | Obstetrical Pad(steam Sterilized) | Paper-Pak Products, Inc. | HHD | Class I | |
| K812208 | Nasal Oxygen Cannula Oxygen Mask | Kamei Intl. Corp. | BYG | Class I | |
| K812189 | Coccidioides Latex Agglutination | American Scientific Products | GMG | Class II | |
| K812186 | Candida Immunodiffusion System | American Scientific Products | LHK | Class II | |
| K812185 | Fungal Immunodiffusion System | American Scientific Products | GMI | Class II | |
| K812181 | Staphylococcal Protein a Insoluble | Oxoid U.S.A., Inc. | LHJ | Class I | |
| K812179 | Life-Tech #1753 Biofeedback Trainer | Life-Tech Instruments, Inc. | HCC | Class II | |
| K812151 | Mj Neonatal Percussor | Cussionair Therapy Products, Inc. | BYI | Class II | |
| K812148 | Electronic Stethoscope #S-50 | Syphgmostat | DQD | Class II | |
| K812141 | Lic Obstetrical Table | Lada Intl., Inc. | KNC | Class II | |
| K812127 | King Diagnostics Hemoglobin Test | King Diagnostics, Inc. | GKR | Class II | |
| K811968 | Vivonex Tungsten Tip | Norwich Eaton Pharmaceuticals, Inc. | KNT | Class II | |
| K811965 | Visitec Needle Range (Gasterurology) | Visitec Co. | FHR | Class I | |
| K811902 | Century Birthing Chair | Century Manufacturing Co. | KNC | Class II | |
| K811885 | 30-30-2 700 Syringe Extension Set | Y | FPA | Class II | |
| K811843 | Biopsy Transducer | Siemens Gammasonics, Inc. | ITX | Class II | |
| K811791 | Phosphate Buffered Saline (1X) | Dutchland Laboratories, Inc. | JCC | Class I | |
| K811482 | Incontinent Pad | Fred Sammons, Inc. | KNO | Class I | |
| K810400 | Glycerine Dehydration Unit | Xytex Corp. |