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 |
|---|---|---|---|---|---|
| K220383 | LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9) | Okami Medical Inc. | KRD | Class II | |
| K220338 | ExacTrac Dynamic | Brainlab, Inc. | IYE | Class II | |
| K220295 | Arietta 50 | Fujifilm Healthcare Corporation | IYN | Class II | |
| K220271 | Hand Diagnostic Radiography Imaging System | Nanoray Biotech Co., Ltd. | KPR | Class II | |
| K220189 | LISA Laser Surgical Fibers | Omni-Guide Holdings, Inc. | GEX | Class II | |
| K220038 | Camber Spine Navigation System | Camber Spine Technologies | OLO | Class II | |
| K214045 | FreedomEdge Syringe Infusion System | Repro-Medical System, Inc., dba Koru Medical Systems | FRN | Class II | |
| K213649 | BodyTom 64 | Samsung HME America, Inc. | JAK | Class II | |
| K213482 | TIA Tip, Cariosity, Transillumination Accessory Tip | D4D Technologies | NTK | Class II | |
| K213334 | Monarch Platform, Urology | Auris Health, Inc | FGB | Class II | |
| K212711 | SteriTite Container System with MediTray Products | Case Medical, Inc. | KCT | Class II | |
| K212514 | Safety Pen Needle for Single Use, Insulin Pen Needles | Berpu Medical Technology Co., Ltd. | FMI | Class II | |
| K212430 | BONREE Nelaton Catheter | Bonree Medical Co., Ltd | EZD | Class II | |
| K212422 | Disposable Surgical Isolation Gown | Crown Name Disposable Hygiene Products Fty. Ltd. | FYC | Class II | |
| K211350 | Bindex BI-2 | Bone Index Finland Ltd. | MUA | Class II | |
| K202977 | Alinity m STI Assay | Abbott Molecular, Inc. | QEP | Class II | |
| K201956 | Zeus IFA ANA HEp-2 Test System, Zeus dIFine | Zeus Scientific LLC | DHN | Class II | |
| DEN200066 | BioFire Joint Infection (JI) Panel | BioFire Diagnostics, LLC | QSN | Class II | |
| K220536 | Digital flat panel detector | Iray Technology Taicang, Ltd. | MQB | Class II | |
| K220264 | EFAI RTSuite CT HN-Segmentation System | Ever Fortune.Ai, Co., Ltd. | QKB | Class II | |
| K220244 | DVR® Crosslock Wrist Spanning Plate (131849181) | Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech | HRS | Class II | |
| K213921 | Microthin Natural Rubber Latex Condom | Suretex, Ltd. | HIS | Class II | |
| K213607 | Geistlich Wound Matrix PLUS | Geistlich Pharma AG | KGN | Unclassified | |
| K213278 | Planmed Verity | Planmed Oy | OAS | Class II | |
| K212512 | G7® Vivacit-E® Freedom® Constrained Liner | Zimmer GmbH | PBI | Class II | |
| K212477 | EARP Interbody System | Nvision Biomedical Technologies, Inc | MAX | Class II | |
| K211715 | RetinAI Discovery | Retinai Medical AG | NFJ | Class II | |
| K211713 | AngioCloud Service | Angiocloud, LLC | LLZ | Class II | |
| K202691 | Ortholock Anchorage Devices | Craniofacial Technologies, Inc. | OAT | Class II | |
| K220898 | NOxBOXi Nitric Oxide Delivery System | Linde Gas & Equipment Inc. | MRN | Class II | |
| K220893 | Strados Remote Electronic Stethoscope Platform (RESP) | Strados Labs Inc. | DSH | Class II | |
| K220892 | ExsoMed INnate NanoTM Lag Screw System | Exsomed Corp. | HWC | Class II | |
| K220645 | Hand-held IPL device (JOVS Hair Removal Device) | Shenzhen Qianyu Technology Co., Ltd. | OHT | Class II | |
| K220604 | EXTesia Introducer Sheath Set | Curatia Medical Co. | DYB | Class II | |
| K220592 | Venus BlissMAX | Venus Concept USA Inc. | PBX | Class II | |
| K220568 | Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series | Cardiovascualr Systems, Inc. | MCW | Class II | |
| K220231 | GyroStim | Ultrathera Technologies, Inc. | LXV | Unclassified | |
| K213265 | Tomey Cornea/Anterior Segment OCT CASIA2 | Tomey Corporation | OBO | Class II | |
| K213236 | ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel | Genmark Diagnostics, Incorporated | PEN | Class II | |
| K213077 | Automatically Retractable Safety Syringe | Zhejiang Lingyang Medical Apparatus Co., Ltd. | MEG | Class II | |
| K213040 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs,Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs | Guangdong Kingfa Sci.&tech.co.,Ltd. | LZA | Class I | |
| K212441 | Philips Incisive CT | Philips Healthcare (Suzhou) Co., Ltd. | JAK | Class II | |
| K220896 | Legion Inserts with JRNY Lock | Smith & Nephew, Inc. | JWH | Class II | |
| K220570 | M.U.S.T. MINI Posterior Cervical Screws System Extension | Medacta International SA | NKG | Class II | |
| K220487 | Disposable Medical Face Mask | Hubei Mediunion Medical Products Co., Ltd. | FXX | Class II | |
| K220222 | IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4 | Shenzhen Yuwei Electronic Technology Co., Ltd. | OHT | Class II | |
| K220219 | PERMALOOP Suture, PERMATAPE Suture | Medos International SARL | GAT | Class II | |
| K213886 | BriefCase | Aidoc Medical Ltd. | QAS | Class II | |
| K213483 | SnapLoc Wire Lock | Wilson-Cook Medical Inc. | ODC | Class II | |
| K212662 | AliveCor QT Service | AliveCor | DQK | Class II |