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 |
|---|---|---|---|---|---|
| K811095 | Transcutaneous Electrical Nerve | Acutec Corporation, Inc. | GZJ | Class II | |
| K811092 | Sterile Packaging | Telectronics, Inc. | DTE | Class II | |
| K811063 | Laser-Cal | Diagnostic Technology, Inc. | KRX | Class II | |
| K811031 | Telesonic & Arcon | Telesonic, Inc. | ESD | Class I | |
| K803086 | Myowire-Atemporary Cardiac Pacing Wire | Craig & Craig, Inc. | LDF | Class II | |
| K811685 | i.v. Administration Set | Quest Medical, Inc | FPA | Class II | |
| K811636 | Norelco Electronic Blood Pressure Meter | North American Philips Corp. | DXN | Class II | |
| K811635 | Norelco Digital Blood Pressure Meter | North American Philips Corp. | DXN | Class II | |
| K811634 | Norelco Aneroid Blood Pressure Meter | North American Philips Corp. | DXQ | Class II | |
| K811512 | Teletrace Telephone EKG System | Medtronic, Inc. | DXH | Class II | |
| K811349 | Model 5866-24 Lead Adaptor Kit | Medtronic, Inc. | DTD | Class II | |
| K811276 | Occlusion Catheter | Bionomy, Inc. | DYG | Class II | |
| K811148 | Vita-Stat Model 9000-S | Viat-Stat | DSK | Class II | |
| K811147 | Vita-Stat Model 9000-a | Vita-Stat | DSK | Class II | |
| K811146 | Vita-Stat Model 8000-C | Vita-Stat | DSK | Class II | |
| K811121 | Central Station Monitoring Systems | Cambridge Instruments, Inc. | DPS | Class II | |
| K810761 | Alpha Micron-40 Filter | Alpha Therapeutic Corp. | CAK | Class II | |
| K810756 | Hemotology Quality Control Mixtures | Scientific Standards, Inc. | JPK | Class II | |
| K811198 | Ecco Generator | Philips North America LLC | IZO | Class I | |
| K811693 | Forder Retractor | Dacomed Corp. | KOA | Class I | |
| K811672 | Norelco Electronic Digital Thermometer | North American Philips Corp. | FLL | Class II | |
| K811659 | Creatinine Reagent | Gilford Diagnostics | CGX | Class II | |
| K811658 | Anis Lens Implant Forceps #2 | American V. Mueller | HNR | Class I | |
| K811639 | Ethix Feeding Tubes Polyurethane/radiop. | Ethox Corp. | KNT | Class II | |
| K811624 | Visio-Seal | Espe-Premier Sales Co. | EBC | Class II | |
| K811580 | Glassman-Dormia Gallstone Extractor Set | Porges Catheter Corp. | FFL | Class II | |
| K811561 | Lo-Vol i.v. Sets | Sea Medical Products, Inc. | FPA | Class II | |
| K811531 | Rionet Hearing Aid Hb-69 | Rion Acoustic Instruments, Inc. | ESD | Class I | |
| K811530 | Rionet Hearing Aid Hb 69 T | Rion Acoustic Instruments, Inc. | ESD | Class I | |
| K811529 | Rionet Hearing Aid Hb-69S | Rion Acoustic Instruments, Inc. | ESD | Class I | |
| K811522 | Re-Hp Series Hearing Aids | Radioear Corp. | ESD | Class I | |
| K811521 | Fuji Ionomer Type I & II | G-C Intl. Corp. | EMA | Class II | |
| K811519 | K-Flex | Sybron Corp. | |||
| K811447 | Shiley Disposable Cannula Trach. Tube | Shiley, Inc. | BTO | Class II | |
| K811434 | Sceptor Id Gram Negative Mic/id Panels | BD Becton Dickinson Vacutainer Systems Preanalytic | JSS | Class I | |
| K811396 | Sonus V | California Technics, Inc. | ELC | Class II | |
| K811288 | Spetzler Lumbar-Peritoneal System | American Heyer Schulte | JXG | Class II | |
| K811287 | Skin Scrub Tray | Associated Medical Products Co. | |||
| K811013 | Summar Non-Precious, Ceramic Alloy | Shofu Dental Corp. | EJH | Class II | |
| K810739 | Suction Wound Drainage Device | The Urology Group | KQT | Class II | |
| K811690 | Ankle-Foot Cast/splint | Surgical Appliance Industries, Inc. | IQI | Class I | |
| K811689 | Cylinder Knee Cast/splint | Surgical Appliance Industries, Inc. | ITQ | Class I | |
| K811675 | Surgical Instruments for Use W/zimmer | Zimmer GmbH | HRX | Class II | |
| K811673 | Total Protein Test | King Diagnostics, Inc. | CEK | Class II | |
| K811664 | Creatinine Test | King Diagnostics, Inc. | CGX | Class II | |
| K811662 | Albumin Test | King Diagnostics, Inc. | CIX | Class II | |
| K811661 | Potassium Test | King Diagnostics, Inc. | CEJ | Class II | |
| K811656 | Powered Wheelchair | The Oec Group | ITI | Class II | |
| K811622 | Emit-St Serum Phenobarbital Calibrator | Syva Co. | DLJ | Class II | |
| K811621 | Emit-St Serum Phenobarbital Assay | Syva Co. | DLZ | Class II |