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 |
|---|---|---|---|---|---|
| K192518 | Reusable Monopolar Active Cord | Us Endoscopy | GEI | Class II | |
| K192360 | IntellaMap Orion High Resolution Mapping Catheter | Boston Scientific Corporation | DRF | Class II | |
| K191874 | F5 Corpus VS | Permobil, AB | IPL | Class II | |
| K191807 | ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device | Alpco | NXO | Class II | |
| K191563 | FILTRAY 2G Disposable Water Filters | Aqua-Tools | NHV | Class II | |
| K191470 | C-CAT Anaesthesia Catheter kit | Cimpax a/S | BSO | Class II | |
| K191085 | Maverick RNP Assay and Maverick Diagnostic System | Genalyte, Inc. | LKO | Class II | |
| K191007 | Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems | Supersonic Imagine | IYN | Class II | |
| K190847 | REDAPT Blade Augments | Smith & Nephew, Inc. | LPH | Class II | |
| K190221 | IOB Warming Blankets | Iob Medical, Inc. | DWJ | Class II | |
| K190181 | Instruments for LINK MEGASYSTEM-C Family | LinkBio Corp. | KRO | Class II | |
| K192728 | Agnes | Agnes Medical Co.,Ltd | GEI | Class II | |
| K192722 | Padlock Clip defect closure system, Padlock Pro-Select defect closure device | STERIS Corporation | PKL | Class II | |
| K192690 | Upgrade Kit MR GUI PRO, MrJ 3300 Plus | ASG Superconductors S.p.A. | LNH | Class II | |
| K192686 | Revolution Maxima, Revolution Ace | GE Hangwei Medical Systems, Co. Ltd | JAK | Class II | |
| K192678 | Genesys Spine Binary® Lumbar Plate System | Genesys Spine | KWQ | Class II | |
| K191944 | MU2net | Dosisoft | IYE | Class II | |
| K191812 | ADI Cervical Interbody Fusion Device | Additive Device, Inc. (Adi) D/B/A Restor3D | ODP | Class II | |
| K191358 | Trident II Acetabular System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | LPH | Class II | |
| K190632 | Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein | Lenora Glove Pvt, Ltd. | KGO | Class I | |
| K190556 | Zimmer Biomet Universal Navigation System | Highridge Medical, LLC | OLO | Class II | |
| K190426 | ALTA Anterior Cervical Corpectomy System | Astura Medical | PLR | Class II | |
| K190349 | MediExpand TL Expandable VBR System | CMF Medicon Surgical Inc | MQP | Class II | |
| K190210 | Tear Pool Dissolvable Punctum Plugs | Alphamed, Inc. | LZU | Unclassified | |
| K190037 | Cronus HP PTA Balloon Catheter | Nipro Medical Corporation | LIT | Class II | |
| K181660 | Acapella Choice Blue Vibratory PEP Device | Abbott Medical | BWF | Class II | |
| K192314 | RESONATE Anterior Cervical Plate System | Globus Medical, Inc. | KWQ | Class II | |
| K191814 | Alliance Glenoid | Zimmer GmbH | KWS | Class II | |
| K191258 | Intraosseous infusion device | Einstein Works, LLC | FMI | Class II | |
| K190157 | Diana ChemoClave Transfer Set | Abbott Medical | ONB | Class II | |
| K183562 | Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs | Encompass Industries Sdn. Bhd. | LZC | Class I | |
| K182743 | Patient-Specific Airway Stent | New Cos, Inc. | NWA | Class II | |
| K192835 | ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K192737 | Rct800 | Ray Co., Ltd. | OAS | Class II | |
| K192623 | LipiFlow Thermal Pulsation System | TearScience, Inc. | ORZ | Class II | |
| K192268 | Europa Pedicle Screw System | Mirus, LLC | NKB | Class II | |
| K192084 | Madison Total Knee System | Implanet | JWH | Class II | |
| K192001 | Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device | Sterilucent, Inc. | FRC | Class II | |
| K191979 | DORO QR3 XTom Headholder System | Black Forest Medical GmbH | HBL | Class II | |
| K191973 | Lumpipulse G CA19-9-N | Fujirebio Dianostics, Inc. | NIG | Class II | |
| K191584 | FORTICO Anterior Cervical Fixation System | Camber Spine Technologies | KWQ | Class II | |
| K191373 | VICRYL Mesh | Ethicon, Inc | FTL | Class II | |
| K191073 | Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter | Vein 360, LLC | NUJ | Class II | |
| K190890 | Exactech Alteon Modular Dual Mobility (MDM) System | Exactech, Inc. | LZO | Class II | |
| K190539 | TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile | Monumedical, LLC | FMG | Class II | |
| K183661 | ClearEdge Balance System | Quadrant Biosciences | LXV | Unclassified | |
| K183309 | stentfix OTSC System Set | Ovesco Endoscopy AG | PKL | Class II | |
| K192659 | Omnipod Insulin Management System, Omnipod DASH Insulin Management System | Insulet Corporation | LZG | Class II | |
| K192616 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ) | Boston Scientific Corporation | FTM | Class II | |
| K192280 | PENTAX Medical ED-3490TK Video Duodenoscope | PENTAX of America, Inc. | FDT | Class II |