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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K180943 | BioWaveGO | Biowave Corporation | GZJ | Class II | |
| K180775 | Watch-PAT300 | Itamar Medical | MNR | Class II | |
| K180574 | Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor | J & J Solutions, Inc. D/B/A/ Corvida Medical | ONB | Class II | |
| K173918 | VersaPAP Positive Airway Pressure (PAP) Device | Trudell Medical International | BWF | Class II | |
| K173773 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT | Medrad, Inc. | DXT | Class II | |
| K173761 | Penumbra System Reperfusion Catheter JET 7 | Penumbra Inc. | NRY | Class II | |
| K173663 | Electronic Stethoscope DS3011A | Imediplus, Inc. | DQD | Class II | |
| K173638 | Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus | Bionime Corporation | NBW | Class II | |
| K173608 | Forest Dental Unit | Forest Dental Products, Inc. | EIA | Class I | |
| K173575 | OsteoReady Dental Implant System | Osteoready, LLC | DZE | Class II | |
| K173516 | NuBorne Infant Warmer | International Biomedical, Ltd. | FMT | Class II | |
| K173509 | Biodegradable Nitrile Powder Free Examination Glove (Blue) | Hartalega Sdn Bhd | LZA | Class I | |
| K173257 | BTI Dental Implant System UnicCa | B.T.I. Biotechnology Institute, S.L. | DZE | Class II | |
| K172492 | Optical Topography System ETG-4100 | FUJIFILM Healthcare Americas Corporation | DQA | Class II | |
| DEN170078 | Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System | Brainways, Ltd. | QCI | Class II | |
| K181909 | Luminelle DTx Hysteroscopy System | Uvision360, Inc. | FAJ | Class II | |
| K181206 | GentleCath Glide Intermittent Urinary Catheter | ConvaTec Limited | GBM | Class II | |
| K181020 | Cytosponge Cell Collection Device | Medtronic, Inc. | EOX | Class II | |
| K180619 | Bongo | Innomed Healthscience, Inc. | OHP | Class II | |
| K180522 | IGTFusion | Igi Technologies | LLZ | Class II | |
| K180077 | NeuroQ 3.8 | Syntermed, Inc. | KPS | Class II | |
| K173454 | Multi-parameter Patient Monitor, models C30 | Shenzhen Comen Medical Instruments Co., Ltd. | MHX | Class II | |
| K181711 | BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel | Microbiologics, Inc. | PMN | Class II | |
| K181676 | Mini Ridge Filter and auxiliary functions for PROBEAT-V | Hitachi Ltd. Healthcare Hitachi Works | LHN | Class II | |
| K181592 | RAIN Sheath Transradial | Cordis US Corp. | DYB | Class II | |
| K181500 | BRILLIANT Crios | Coltene /Whaledent AG | EBF | Class II | |
| K181407 | Artis zee/zeego & Artis Q/Q.zen | Siemens Medical Solution USA, Inc. | OWB | Class II | |
| K181359 | InterActive SMARTBase Abutments | Implant Direct Sybron Manufacturing LLC | NHA | Class II | |
| K181347 | Aries® Lumbar Interbodies | Osseus Fusion Systems LLC | MAX | Class II | |
| K181308 | SuperGrow 272, Ultimate 272 | Super Grow Lasers | OAP | Class II | |
| K181289 | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System | Cepheid | OCC | Class II | |
| K180428 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | JGS | Class II | |
| K173703 | Sonata Sonography-Guided Transcervical Fibroid Ablation System | Gynesonics, Inc. | KNF | Class II | |
| K182067 | PleuraFlow System with FlowGlide Extra Drainage Length | Clearflow, Inc | OTK | Class II | |
| K181977 | WiScope Digital Endoscope System | OTU Medical Inc | FGB | Class II | |
| K181792 | Duo™ Lumbar Interbody Fusion Device | Spineology, Inc. | MAX | Class II | |
| K181414 | uCT 530, uCT 550 | Shanghai United Imaging Healthcare Co., Ltd. | JAK | Class II | |
| K180131 | Vicks RapidRead Digital Thermometer | Kaz USA, Inc., A Helen of Troy Company | FLL | Class II | |
| K173620 | Mag Vita TMS Therapy System w/Theta Burst Stimulation | Tonica Elektronik a/S | OBP | Class II | |
| K181978 | Zenius™, Iliad™ and Kora™ Spinal Fixation Systems | Medyssey USA | NKB | Class II | |
| K181593 | Vantage Galan 3T, MRT-3020/A7, V5.0 | Canon Medical Systems Corporation | LNH | Class II | |
| K181318 | Onis-Pacs | Digitalcore Co., Ltd. | LLZ | Class II | |
| K180990 | TirboLOX-L Lumbar IBFD | CAPTIVA SPINE, Inc. | MAX | Class II | |
| K180962 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | JEY | Class II | |
| K180539 | Deformity Analysis and Correction Software (DACS) and Instrumentation | Arrowhead Medical Device Technologies, LLC | OSN | Class II | |
| K173549 | Biafine | Valeant Pharmaceuticals | FRO | Unclassified | |
| K173498 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | DiaSorin Molecular LLC | OZZ | Class II | |
| K173123 | Pulse Oximeter | Shenzhen Imdk Medical Technology Co., Ltd. | DQA | Class II | |
| K173248 | Cardioskin | Bioserenity SAS | DXH | Class II | |
| K181891 | Portable X-ray System (Model: MiniX-V, Mini X-S) | Digimed Co., Ltd | EHD | Class II |