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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K252451 | EPORE® XO cup system | implantcast GmbH | OQI | Class II | |
| K252431 | Elecsys Calcitonin | Roche Diagnostics GmbH | JKR | Class II | |
| K252337 | EdgeFlow Gel Pad | Edgecare Inc. | MUI | Class II | |
| K252336 | Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay | Diazyme Laboratories, Inc. | |||
| K250349 | Vista CMS | Shanghai Draeger Medical Instrument Co., Ltd. | MHX | Class II | |
| K250242 | Compression Therapy Device (LGT-2202DVT) | Guangzhou Longest Medical Technology Co., Ltd. | JOW | Class II | |
| K250234 | SMARTeZ™ Elastomeric Infusion Pump (RS series) | Epic Medical Pte., Ltd. | MEB | Class II | |
| K261012 | OptiMap Catheter - 60mm (OPTI-CATH2-60) | Cortex, Inc. | MTD | Class II | |
| K260976 | NeuroBlate System | Monteris Medical Corp | ONO | Class II | |
| K260947 | 0.55T 12Ch Breast Coil | NeoCoil, LLC | MOS | Class II | |
| K260785 | DS Core CBCT Anatomy | Dentsply Sirona Inc | QIH | Class II | |
| K260320 | Lunit INSIGHT MMG (v1.1.10) | Lunit Inc. | QDQ | Class II | |
| K260195 | Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae | Medtronic, Inc. | DWF | Class II | |
| K260152 | Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) | Mmtech Projetos Tecnologicos Importacao e Exportacao Ltda. | EBF | Class II | |
| K254248 | Introducer Sheath Set | Cardiocycle Medical(suzhou) Co.,Ltd. | DYB | Class II | |
| K254237 | Cci Pacs Viewer (Pacs-US-001) | Clinicomp Intl., Inc. | LLZ | Class II | |
| K253752 | ARTIS genio floor; ARTIS icono.explore floor | Siemens Medical Solutions USA, Inc. | OWB | Class II | |
| K253589 | Liberant™ RX Aspiration Catheter | Medtronic Interventional Vascular, Inc. | QEZ | Class II | |
| K252815 | ProBeam 360 Proton Therapy System v3.0 | Varian Medical Systems, Inc. | LHN | Class II | |
| K252436 | Tula Tympanostomy Tube Delivery Device | Tusker Medical Inc. | ETD | Class II | |
| K252407 | OxyGo Portable Oxygen Concentrator (1400-7000) | Mv Life, LLC | CAW | Class II | |
| K252389 | Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) | Smwmed Inc. | DSH | Class II | |
| K252341 | Evis Exera III Bronchovideoscope (Olympus Bf-Q190); Evis Exera III Bronchovideoscope (Olympus Bf-H190 ); Evis Exera III Bronchovideoscope (Olympus Bf-1Th190) | Olympus Medical Systems Corp. | EOQ | Class II | |
| K260570 | corra™ cervical plating system | Carlsmed, Inc. | KWQ | Class II | |
| K260239 | Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862) | Jiangxi Aov Maternity & Baby Products Co., Ltd. | HGX | Class II | |
| K260237 | Mobility Scooter (X-12, X-14, X-17) | Wuyi Aichi Industry & Trade Co., Ltd. | INI | Class II | |
| K260150 | LED Facial Mask (Mj-66Db, Mk-99, Mk-99A, Mk-99M, Mj-66C) | Nooance | OHS | Class II | |
| K253765 | Vanish Pro | DDC Technologies, Inc. | GEX | Class II | |
| K253256 | myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) | Otto Bock Healthcare Products GmbH | GXY | Class II | |
| K253230 | ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe | ERBE Elektromedizin GmbH | GEH | Class II | |
| K253163 | Efai Ersuite CT Appendicitis Assessment System (Appen-CT-100) | Ever Fortune.Ai, Co., Ltd. | QAS | Class II | |
| K253077 | uOmnispace.MR | Shanghai United Imaging Healthcare Co., Ltd. | QIH | Class II | |
| K252306 | Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA™ Auto-Reader (Model: 1100) | Steritec Products, Inc. | QVB | Class II | |
| K260921 | Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line | Tigon Medical LLC | MBI | Class II | |
| K260573 | EvoEndo Single-Use Endoscopy System | Evoendo, Inc. | FDS | Class II | |
| K260518 | IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F) | Shenzhen Semlamp Intelligent Technology Co., Ltd | OHT | Class II | |
| K260447 | ETEST Gepotidacin (GEP) (0.016-256 µg/mL) | bioMerieux, Inc. | JWY | Class II | |
| K260216 | CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System | Medtronic Sofamor Danek USA Inc | NKB | Class II | |
| K254046 | BosCATH Support Catheter | Sonorous NV, Inc. | QJP | Class II | |
| K253982 | Korotkoff sound blood pressure monitor | Beijing Hanvon Health Technology Co., Ltd. | DXN | Class II | |
| K250793 | RhythmStar System (SL) | Rhythmedix | QYX | Class II | |
| K260212 | EnSite™ X EP System | Abbott Medical | DQK | Class II | |
| K260153 | Q-Switched Nd: YAG Laser System (Glamor Q) | Nanjing Bestview Laser S&T Co.,Ltd. | GEX | Class II | |
| K253806 | Power Wheelchair (N5919 series) | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | ITI | Class II | |
| K253638 | xStep (xStep) | Spinex, Inc. | SDO | Class II | |
| K253558 | Luminoah FLOW™ Enteral Nutrition System | Luminoah | LZH | Class II | |
| K253213 | SAGI Cervical Cage System | Zhejiang Decans Medical Devices Co.,Ltd. | OVE | Class II | |
| K253003 | Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025) | Hubei Xinxin Non-woven Co., Ltd | FYA | Class II | |
| K252718 | Lunar Astra | GE Healthcare | KGI | Class II | |
| K252332 | Folliscan | Mim Fertility | QIH | Class II |