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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K970098 | E100 Series Spo2 Sensors | Epic Medical Equipment Services, Inc. | DQA | Class II | |
| K981274 | Acromed Timx Plate Based Low Back System | Acromed Corp. | MNH | Class II | |
| K981255 | Sigma Diagnostics Accuclot Control III | Sigma Diagnostics, Inc. | GGN | Class II | |
| K981254 | Sigma Diagnostics Accuclot Control II | Sigma Diagnostics, Inc. | GGN | Class II | |
| K981248 | Sigma Diagnostics Accuclot Control I | Sigma Diagnostics, Inc. | GGN | Class II | |
| K981081 | Brightstar | Hill-Rom Inc. | FSY | Class II | |
| K981060 | Abbott Axsym 3Rd Generation Tsh Assay | Abbott Medical | JLW | Class II | |
| K980791 | Dumex Pak-Its Woven Ribbon Packing | Dumex Medical Surgical Products, Ltd. | EFQ | Unclassified | |
| K980784 | Suretouch | Sahar Technologies, Inc. | GEX | Class II | |
| K980776 | One Step Urine Drug of Abuse: Benzodiazepine Test | Tcpi, Inc. | JXM | Class II | |
| K980774 | Osteonics Gap-II Restoration Acetabular Shells | Osteonics Corp. | LZO | Class II | |
| K980681 | Innovasive Devices Meniscal Screw | Innovasive Devices, Inc. | HWC | Class II | |
| K980545 | The Nuffield Total Knee System | Corin USA | JWH | Class II | |
| K980491 | Innovasive Linx Tibial Ligament Fastener | Innovasive Devices, Inc. | MBI | Class II | |
| K980373 | Ultramind Biofeedback System with De-Stress Software | Ultramind International, Ltd. | HCC | Class II | |
| K980364 | Howmedica and Howmedica Leibinger Bone Screw Washers | Howmedica Corp. | HWC | Class II | |
| K980360 | Scimed Quest Floppy and Moderate Support Guide Wires | Scimed Life Systems, Inc. | DQX | Class II | |
| K974674 | Cynosure Photolight Flashlamp System | Cynosure, LLC | GEX | Class II | |
| K980848 | Hypoallergenic Latex Patient Exam Gloves-Prepowdered | P.T. Irama Dinamika Latex | LYY | Class I | |
| K980592 | Ntech Cystoscopes | N-Tech Endoscopy, Inc. | FAJ | Class II | |
| K980549 | Osseotite Dental Implant System | ZimVie US Corp LLC | DZE | Class II | |
| K980493 | i.v. Catheter System | Johnson & Johnson MEDICAL GmbH | FOZ | Class II | |
| K980350 | Video Camera/lightsource Combination Unit Model Vcl-150 | Cuda Products Co. | GCJ | Class II | |
| K980346 | Electrical Muscle Stimulator Device ( Pgs-4000) | Universal Technology Systems, Inc. | IPF | Class II | |
| K972996 | Easy ECG Pc Based Electrocardiograph | Ates Medical S.r.l. | DPS | Class II | |
| K970158 | Babypac | Pneupac, Ltd. | CBK | Class II | |
| K981289 | N-Assay L T-Bil | Crestat Diagnostics, Inc. | CIG | Class II | |
| K981178 | Thrombolytic Assessment System Low Range Heparin Management Test Controls | Cardiovascular Diagnostics, Inc. | GGN | Class II | |
| K981102 | Stratus Cs Myoglobin (Myo) Testpak | Siemens Healthcare Diagnostics Inc. | DDR | Class II | |
| K981098 | Stratus Cs Cardiac Troponin I Testpak | Siemens Healthcare Diagnostics Inc. | MMI | Class II | |
| K980944 | Synthes Schuhli Implant System | Synthes (USA) Products LLC | HTN | Class II | |
| K980772 | Hdl-Cholesterol Precipitating Reagent, Catalogue Number 205-51 | Sekisui Diagnostics P.E.I. Inc. | LBR | Class I | |
| K980660 | Biogold Plus Dental Alloy | European Dental Imports, Inc. | EJT | Class II | |
| K980583 | Extension Set with 0.2U Filter and Anti-Siphon Valve Cadd Administration Set with 0.2U Filter and Anti-Siphon Valve | Sims Deltec, Inc. | FPA | Class II | |
| K980436 | Class III Reverse Pull Facemask | Ortho Kinetics Corp. | DZB | Class II | |
| K980372 | Manan Vs Access Needle/set | Medical Device Technologies, Inc. | FGE | Class II | |
| K980334 | Innovasive 10Mm Linx Ht Ligament Fastener | Innovasive Devices, Inc. | MBI | Class II | |
| K980058 | Tokuso Mac Bond II | Tokuyama America Inc. | EBF | Class II | |
| K980054 | Palfique Estelite | Tokuyama America Inc. | EBF | Class II | |
| K974117 | Pelvx Donut, Pelvx Cube | Deschutes Medical Products, Inc. | HHW | Class II | |
| K974116 | Pelvx Incontinence Ring | Deschutes Medical Products, Inc. | HHW | Class II | |
| K974115 | Pelvx Ring, Pelvx Ring with Support | Deschutes Medical Products, Inc. | HHW | Class II | |
| K973237 | Css-Cardioplegia Safety System | Medtronic Bio-Medicus, Inc. | DWB | Class II | |
| K972894 | Autotransfusion Appartus (Autolog) | Medtronic Blood Management | CAC | Class II | |
| K972911 | Auto Suture*endostitch* II** Suture Applier | United States Surgical, A Division of Tyco Healthc | GAT | Class II | |
| K981436 | Document Ammonia/ethanol/lactate Calibrator, Pn: M-109 | Casco Standards | JIX | Class II | |
| K981281 | Elecsys Calcheck Ferritin | Roche Diagnostics GmbH | JJX | Class I | |
| K981222 | Direct Bilirubin (Dbil) | Abbott Medical | CIG | Class II | |
| K981123 | Urea | Trace Scientific, Ltd. | CDQ | Class II | |
| K980614 | Abbott Cell-Dyn 3000 Series Hematology Systems | Abbott Medical | GKZ | Class II |