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 |
|---|---|---|---|---|---|
| K913694 | Palco Labs Loadmatic | Palco Laboratories, Inc. | FMF | Class II | |
| K913645 | Specialty Controls Interface | Everest & Jennings, Inc. | ITI | Class II | |
| K913641 | Sophy Nxt | Sopha Medical Systems, Inc. | KPS | Class II | |
| K913384 | Columnmate(tm) Beta-Thal Cat. No. 4515 | Helena Laboratories, Corp. | JPD | Class II | |
| K913351 | Influenza Mab Test/influenza a Test | Gull Laboratories, Inc. | GNW | Class I | |
| K912902 | Phacoemulsification System for Ophthalmic Use | Site Microsurgical Systems, Inc. | HQC | Class II | |
| K912856 | Mede-Flo i.v. Extension Set | Medevice, Inc. | FPA | Class II | |
| K912398 | Endopath Surg Disp Trocar(shield/unshielded),modif | Ethicon, Inc | HET | Class II | |
| K912140 | Stairmaster Model 6000 Ergometer | Tri-Tech, Inc. | ISD | Class II | |
| K911733 | Intelect, Model 245 | Chattanooga Group, Inc. | IMG | Class II | |
| K911117 | Interson Endocavity Probe for Atl Ultrasound Syst | Interson Corp. | ITX | Class II | |
| K911115 | Interson Transrectal Probe/atl Ultrasound System | Interson Corp. | ITX | Class II | |
| K911113 | Interson Transrectal Probe/kontron Ultrasound Syst | Interson Corp. | ITX | Class II | |
| K905552 | Laparolith | Baxter Healthcare Corporation | LQC | Class II | |
| K915200 | Precise Tm Hcg for Use in the Physicians Office La | Becton Dickinson Advanced Diagnostics | JHI | Class II | |
| K914740 | Asl Model #103 | Adaptive Switch Laboratories, Inc. | ITI | Class II | |
| K914739 | Asl Model #102 | Adaptive Switch Laboratories, Inc. | ITI | Class II | |
| K914239 | Frames (Spectacles) | Jane Fui Optical Co., Ltd. | HQZ | Class I | |
| K914230 | Axiom Total Knee System, All Poly Tibial Tray | Orthomet, Inc. | JWH | Class II | |
| K914003 | Midas Bracket | Gold'N Braces, Inc. | EJF | Class I | |
| K913980 | Heliolux | Ivoclar North America, Inc. | EBZ | Class II | |
| K913857 | Rocatec(r) -Plus | Espe GmbH (US) | EJH | Class II | |
| K913678 | Trocar Catheter | Medovations, Inc. | KGY | Class I | |
| K913634 | Apr II Hip System | Intermedics Orthopedics | JDI | Class II | |
| K913484 | Zoll D-900 Defibrillator | Zmi Corp. | LDD | Class II | |
| K912514 | Tandem Scanning Microscope | Tandem Scanning Corp. | HJO | Class II | |
| K914917 | Du Pont Total Protein/albumin Calibrator | E.I. Dupont de Nemours & Co., Inc. | JIX | Class II | |
| K914361 | Creatine Kinase Mb Test Item Number 5A46 | Em Diagnostic Systems, Inc. | CGS | Class II | |
| K914252 | Ascentec Mediczal Systems Laparoscopic Electrode | Ascentec Medical Systems | GEI | Class II | |
| K914157 | Dressing/cvp Dressing Change/hyperaliment Trays | Cml, Inc. | LYY | Class I | |
| K914149 | Femoral Artery Pressure Pad/disk | Disco, Inc. | DXC | Class II | |
| K914138 | Ontrac | Lake Region Mfg., Inc. | DQX | Class II | |
| K913963 | Immuchem Neonatal Tsh-Mp Elisa | Icn Biomedicals, Inc. | JLW | Class II | |
| K913907 | Vivus Ps (Programming Software) | Halyard Health | FRN | Class II | |
| K913885 | Rinn E-Z Capper | Rinn Corp. | FMI | Class II | |
| K913214 | Influenza Mab Test/influenza B Test | Gull Laboratories, Inc. | GNW | Class I | |
| K913026 | Ttu-100Thermal Therapy Unit | Danninger Medical Technology, Inc. | ILO | Class II | |
| K912919 | Mentor Infusion Line | Mentor | KNY | Class II | |
| K912908 | Air-Shields Micro-Lite Phototherapy System | Air-Shields Vickers, Inc. | LBI | Class II | |
| K912103 | Lifeshield Extension Set | Abbott Medical | FPK | Class II | |
| K913636 | Orbis-Sigma Valve System for Ventricular Shunting | Cordis US Corp. | JXG | Class II | |
| K912446 | Modif. Laserflo Blood Perfusion Monitor Model Bpm2 | Vasamedics, LLC | DPW | Class II | |
| K913316 | Devilbiss Model 7427D | Devilbiss Health Care, Inc. | CAF | Class II | |
| K913082 | Bi-Temp Temperature Monitor,model Tm-300D | Respiratory Support Products, Inc. | FLL | Class II | |
| K912532 | Itc Hieshima Taper Select(tm) Percutaneous Cath | Interventional Therapeutics Corp. | DQO | Class II | |
| K912165 | Landmark Dual-Lumen Midline Catheter System | Menlo Care, Inc. | FOZ | Class II | |
| K911192 | Dp 100 | Ferguson Medical | CAF | Class II | |
| K914841 | Chromatography Clinical Use 75Jqr | EMD Millipore Corporation | KIE | Class I | |
| K914533 | Micro Eia for Cocaine Metabolites | Microdiagnostics, Inc. | DIO | Class II | |
| K914391 | Albumin Test Rid Kit | The Binding Site | DCF | Class II |