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 |
|---|---|---|---|---|---|
| K080179 | Reflexion Hd High-Density Mapping Catheter | Abbott Medical | DRF | Class II | |
| K073618 | Verify Sirius Biological Indicator Challenge Pack | STERIS Corporation | FRC | Class II | |
| K071754 | Neo-Vagina Surgery Set and Accessories | Karl Storz Endoscopy-America, Inc. | HDX | Class II | |
| K083494 | Ultima Five | Pain Management Technologies | GZJ | Class II | |
| K082943 | Iroot Bp, Model Irbp 4609 | Innovative BioCeramix, Inc | KIF | Class II | |
| K082857 | Renegade Wheelchair | Alpha One | IQC | Class II | |
| K082750 | Entact Septal Stapler, Model 610-00100 | Entrigue Surgical, Inc. | OLL | Class II | |
| K081258 | Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02 | Biosense Webster Inc | DRF | Class II | |
| K082526 | Cardio Vue Quantitative Analysis (Cvq) | Mri Cardiac Services, Incorporated | LLZ | Class II | |
| K082473 | Bausch & Lomb Stellaris Microsurgical System | Bausch & Lomb Incorporated | HQC | Class II | |
| K081877 | Associate 2500 Dual and Compact Systems | Dutch Ophthalmic Research Center International BV | HQC | Class II | |
| K081816 | Vocalis and Vocalis Sm | Cytophil, Inc | MIX | Class II | |
| K081815 | Vocalis Gel | Cytophil, Inc | MIX | Class II | |
| K083646 | Micrus Microcoli System, Deltaplush, Models Cpl, Dpl | Micrus Endovascular Corporation | HCG | Class II | |
| K082983 | Resscan-Pro | ResMed Corp | BZD | Class II | |
| K082979 | S8 Advance | ResMed Corp | BZD | Class II | |
| K082968 | Apneicare Connection Center/internet Analysis | Apneicare, LLC | MNR | Class II | |
| K082712 | Theken Spine Vu Epod and Vu Lpod System | Theken Companies LLC | MAX | Class II | |
| K082396 | Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087 | C.R. Bard Inc | GDW | Class II | |
| K082351 | Neptune Hyperbaric Ventilator | Level-5, Inc. | CBK | Class II | |
| K082291 | A-Lap Set (a-Lap, Ezaxess, Trocar) | Ezsurgical | GCJ | Class II | |
| K083452 | Erbe Model Vio 300 D with Accessories | Erbe USA Inc | GEI | Class II | |
| K080740 | Clearview Endoscope Cover | Invotec International, Inc. | EOB | Class II | |
| K080455 | Rapidsense Drugs of Abuse Methamphetamine (Met) 1000 Device, Model 900-0050 | Quantrx Biomedical Corporation | LAF | Class II | |
| K083765 | Maxguard Advanced Luer Activated Device with Antimicrobial | Medegen Medical Manufacturing Services | FPA | Class II | |
| K083673 | Carestream Pacs, Model Carestream Pacs VII | Eastman Kodak Company | LLZ | Class II | |
| K083213 | Synthes 2.7 Mm/3.5 Mm Lcp Distal Fibula Plates | Synthes (USA) Products LLC | HRS | Class II | |
| K082999 | Arthrex Meniscal Dart, Arthrex Meniscal Dartstick, Arthrex Chondral Dart | Arthrex GmbH | MAI | Class II | |
| K082878 | Nevoni Classic, Model 6600-Po | Nsr Comercio E Representacoes Ltda | CAF | Class II | |
| K082652 | Bittar Zirconia Blocks | Bittar Zirconia Block, LLC | EIH | Class II | |
| K082613 | Merit Microcatheter | Merit Medical Systems, Inc. | KRA | Class II | |
| K082472 | Virocult, Model Mw950 | Medical Wire & Equipment Company (Bath), Ltd. | LIO | Class I | |
| K082435 | Amsco Evolution Medium Steam Sterilizer | STERIS Corporation | FLE | Class II | |
| K082203 | Numeris Coagulation System with Visitrax, Model(s) Csk-021;Csk-022; Csk-023; Csk-025 | Ncontact Surgical, Inc. | OCL | Class II | |
| K072964 | Nicolet Cortical Stimulator | Medtronic, Inc. | GYC | Class II | |
| K083591 | Ikoengelo, Version 2 | Ikoetech, LLC | KPQ | Class II | |
| K083542 | Fresenius Sterile Stay Safe Cap | Fresenius Medical Care Renal Therapies Group, LLC | KDJ | Class II | |
| K083355 | Wound Wash Saline, 210 Ml, Model B8552, Wound Wash Saline, 90 Ml, Model B8553 | Blairex Laboratories, Inc. | FRO | Unclassified | |
| K083210 | Corflo Anti IV Enteral Feeding Tube | Halyard Health | FPD | Class II | |
| K083050 | Evite Xl | Draeger Medical AG & Co. KG | CBK | Class II | |
| K083026 | Clydesdale Spinal System | Medtronic Sofamor Danek | MAX | Class II | |
| K082946 | Mortara Eli 350 Electrocardiograph | Mortara Instrument, Inc. | DPS | Class II | |
| K082892 | Rejuvenate Monolithic Hip System | Howmedica Osteonics Corp | MEH | Class II | |
| K082792 | Medacta Total Hip Prosthesis System - Quadra H and R Femoral Stems | Medacta International SA | JDI | Class II | |
| K082709 | Vicor Pd2i Analyzer, Version 2.1 | Vicor Technologies, Inc. | DPS | Class II | |
| K082010 | Stryker Disposable Cranial Perforator Bit | Stryker Ireland Ltd., Instruments Division | HBF | Class II | |
| K081962 | Lapex Bcs | Meridian AG | ILY | Class II | |
| K083657 | Conquest Pta Balloon Dilatation Catheter | C.R. Bard Inc | DQY | Class II | |
| K083572 | BD BACTEC Plus Aerobic/F Culture Vials | Becton Dickinson & Co | MDB | Class I | |
| K083347 | Impulse 7010 Defibrillator Selectable Loads | Fluke Biomedical | DRL | Class II |