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 |
|---|---|---|---|---|---|
| K223854 | Unistik® ShieldLock, Unistik VacuFlip | Owen Mumford Limited | JKA | Class II | |
| K223694 | Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) | Duearity AB | KLW | Class II | |
| K223374 | Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co.,Ltd | DXN | Class II | |
| K223135 | AblatePal Radiofrequency Ablation System | Compal Electronics, Inc | GEI | Class II | |
| K222466 | AirTom | Bilab | QEB | Class II | |
| K221294 | preCARDIA Occlusion System | Abiomed, Inc. | MJN | Class II | |
| K213253 | Pixyl.Neuro | Pixyl SA | LLZ | Class II | |
| K212409 | Ulspira TS Nitric Oxide Therapy System | Airgas Therapeutics LLC | MRN | Class II | |
| K231691 | Phantom XL Insulated Dilators | Tedan Surgical Innovations, Inc. | GXZ | Class II | |
| K231647 | XENOVIEW 3.0T Chest Coil | Polarean, Inc. | MOS | Class II | |
| K231553 | OverStitch NXT Endoscopic Suturing System | Apollo Endosurgery, Inc. | OCW | Class II | |
| K231549 | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System | Boston Scientific Corporation | OTN | Class II | |
| K231101 | Flume Catheter | The Flume Catheter Company Ltd | EZL | Class II | |
| K230866 | HotDog Warming Mattress + Return Electrode | Augustine Temperature Management, LLC | DWJ | Class II | |
| K230595 | OsteoCentric ACL Fixation System | OsteoCentric Technologies,Inc | HWC | Class II | |
| K230374 | Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®) | Dongguan TT Medical, Inc. | LOX | Class II | |
| K230337 | EarliPoint | Earlitec Diagnostics | QPF | Class II | |
| K230176 | Upper Arm Blood Pressure Monitor | Shenzhen Yolanda Technology Co., Ltd. | DXN | Class II | |
| K223596 | SQ.line KERRISON | Aesculap Inc | HAE | Class II | |
| K223047 | NeuroSwift Pro | Neurobit Technologies Co., Ltd. | GWN | Class II | |
| K222933 | Myah | VISIA imaging S.r.l. | MXK | Class II | |
| K221436 | F&P 950 Accessory Breathing Circuit Kits | Fisher & Paykel Healthcare, Inc. | BZD | Class II | |
| DEN200052 | KidneyIntelX.dkd | Renalytix Ai, Inc. | QWZ | Class II | |
| K231232 | Curiteva Laminoplasty System | Curiteva, Inc. | NQW | Class II | |
| K230859 | Aneroid Sphygmomanometer | Wenzhou Kangshun Medical Devices Co.,Ltd. | DXQ | Class II | |
| K230075 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K | Microlife Intellectual Property GmbH | DXN | Class II | |
| K223722 | MIO Blood Glucose Monitoring System | Mio Labs Inc. | NBW | Class II | |
| K220198 | Medi Lift PLUS | YA-Man Ltd. | NFO | Class II | |
| K213652 | Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) | Cresilon Inc | QSY | Unclassified | |
| K210924 | e-Celsius Medical System | Bodycap | FLL | Class II | |
| K231636 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. | L&K Biomed Co.,Ltd. | NKB | Class II | |
| K231219 | NobelZygoma PureSet™ Tray | Nobel Biocare Services AG | KCT | Class II | |
| K231124 | Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G) | Owen Mumford Limited | FMK | Class II | |
| K230876 | RI.KNEE Adjustable Tibia Cut Guide | Enztec Limited | OLO | Class II | |
| K230861 | VADER® Pedicle System Navigated Instruments | Icotec AG | OLO | Class II | |
| K230706 | EMBOLD™ Soft Detachable Coil System | Boston Scientific Corporation | KRD | Class II | |
| K223100 | Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) | MEDLINE INDUSTRIES, LP - Northfield | CAF | Class II | |
| K222492 | Hope&Her Vaginal Dilators | Lujena, Inc. | HDX | Class II | |
| K213046 | AceConnex Pre-Sutured Fascia | Allosource | GAT | Class II | |
| K231215 | IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S | Zhongshan Qizhe Technology Co., Ltd. | OHT | Class II | |
| K230914 | ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146) | ArthroCare Corporation | GEI | Class II | |
| K230867 | Bone Bolt System | University of Utah, Department of Orthopaedics | HWC | Class II | |
| K230492 | Avitus® Precision Autograft Delivery System | Avitus Orthopaedics, Inc | FMF | Class II | |
| K223143 | SAGICO Spinal System | Sagico VA USA, LLC | OVE | Class II | |
| K223138 | AB1 Electrosurgical Instrument, Creo Electrosurgical System | Creo Medical Ltd | NEY | Class II | |
| K222378 | VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL) | bioMerieux, Inc. | LON | Class II | |
| K221488 | Z7 Zirconia Implant System | Z7 LLC | DZE | Class II | |
| K222142 | BR SLA Type Implant System | Biotem Co., Ltd. | DZE | Class II | |
| K231532 | ActiGraph LEAP activity monitor (ActiGraph LEAP) | ActiGraph L.L.C. | LEL | Class II | |
| K231505 | GORE® ACUSEAL Vascular Graft | W. L. Gore & Associates, Inc. | DSY | Class II |