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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
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	2,732

176,529 records, page 1538 of 3531

510(k) clearances, page 1538 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K021255	Y.e.s 10 Wheelchair	Movingpeople.Net	ITI	Class II	2002-05-02
K021120	Radial Artery Catherization Set with Integral Needle Protection,model Ra-04020-Sp	Arrow Intl., Inc.	DQY	Class II	2002-05-02
K021117	Tti Thermomed Model 1.8 Instrument	Thermosurgery Technologies, Inc.	GEI	Class II	2002-05-02
K021088	Joguide Cardiovascular Guiding C Atheter	Jomed Catheter, Inc.	DQY	Class II	2002-05-02
K021074	Visera Cystovideoscope Olympus Cyf Type V/va	OLYMPUS Corporation of the Americas	FAJ	Class II	2002-05-02
K020930	Menicon Progent Remover for Rigid Gas Permeable Contact Lenses	Menicon Co. Ltd.	MRC	Class II	2002-05-02
K020787	Verdict-II Propoxyphene	MEDTOX Diagnostics, Inc.	JXN	Class II	2002-05-02
K020758	Varelisa Cardiolipin Igm Antibodies, Models 15648 & 15696	Pharmacia Deutschland GmbH	MID	Class II	2002-05-02
K020757	Varelisa Cardiolipin Iga Antibodies, Models 15748 & 15796	Pharmacia Deutschland GmbH	MID	Class II	2002-05-02
K020752	Varelisa Cardiolipin Igg Antibodies, Models 15548 & 15596	Pharmacia Deutschland GmbH	MID	Class II	2002-05-02
K020751	Syntex Powder-Free Polymer-Coated Nitrile Examination Glove	Syntex Healthcare Products Co., Ltd.	LZA	Class I	2002-05-02
K020687	Diastat Anti-Thyroid Peroxidase Elisa Model #300	Axis-Shield Diagnostics, Ltd.	JZO	Class II	2002-05-02
K020623	Duopro Safety Syringe (Duopross)	MK Meditech	MEG	Class II	2002-05-02
K020567	Akuport M1	Vibrant Health	GZO	Class II	2002-05-02
K020471	Hivox Ear Thermometer, Ts Series	Hivox Biotek Inc.	FLL	Class II	2002-05-02
K020408	System 2000 Controller, System 5000 Controller, Footswitch, Power Cord, and Visage Wandsff	ArthroCare Corporation	GEI	Class II	2002-05-02
K020349	Abbott Axsym Anti-Thyroglobulin, Models 5F5b Comprising Standard/calibrators	Axis-Shield Diagnostics, Ltd.	JZO	Class II	2002-05-02
K020348	Abbott Axsym Anti-Thyroid-Peroxidase, Models5f57 Comprising Standards/calibrators	Axis-Shield Diagnostics, Ltd.	JZO	Class II	2002-05-02
K020344	Rpx Titanium Cemnt Restrictor	Zimmer Spine, Inc.	JDK	Class II	2002-05-02
K020341	Given Diagnostic System	Given Imaging Ltd.	NEZ	Class II	2002-05-02
K013484	Telstar Magnetic Navigation Systems [Mns}, Telstar Bi-Plane Digital Imaging System, Niobe Electrophysiology Mapping Cath	Stereotaxis Inc	DRF	Class II	2002-05-02
K011727	Transseptal Needle/trocar	Merit Medical Systems, Inc.	DRC	Class II	2002-05-02
K021217	Arox 53-Bp; Arox 60-Bp; Arox 45-Jbp; Arox 53-Jbp	BIOTRONIK AG	DTB	Class III	2002-05-01
K021204	Olympus Bf Type Um40	Olympus Optical Co., Ltd.	PSV	Class II	2002-05-01
K021073	Visera Rhinlaryngovideoscope Olympus Enf Type V	OLYMPUS Corporation of the Americas	EOB	Class II	2002-05-01
K020648	Gridlock 195 Adhesive	Allodex Systems	DYH	Class II	2002-05-01
K020576	Velogene Genomic Identificationassay for Vre	Id Biomedical Corp.	NIJ	Class II	2002-05-01
K020502	Solo Ortho 3	Sybron Dental Specialties, Inc.	DYH	Class II	2002-05-01
K020053	Safe Shield Poweder-Free Latex Examination Gloves	Safe Shield Co., Ltd.	LYY	Class I	2002-05-01
K013888	Fixation (Steinmann) Pins	Miltex, Inc.	HTY	Class II	2002-05-01
K013802	Frc Postec	Ivoclar Vivadent, Inc.	ELR	Class I	2002-05-01
K012614	Kendall, Sequential Compression Device; Huntleigh, Flowtron; Venaflow; Acufex; Alps; Sheepskin	Medical Instruments Technology, Inc.	JOW	Class II	2002-05-01
K011859	Klimamed Thermal Mat & Controller 95 and 55 Watts	Klimamed Technologie Medizingerate GmbH	DWJ	Class II	2002-05-01
K021359	Digi-Pro TENS Model Wl-2203 and Wl-2205	Well-Life Healthcare Limited	GZJ	Class II	2002-04-30
K020691	Microscan Microstrep Plus Panel New Antimicrobial - Cefaclor	Dade Microscan, Inc.	JWY	Class II	2002-04-30
K020686	Microscan Microstrep Plus Panel New Antimicrobial - Trimethoprim/sulfamethoxazole	Dade Microscan, Inc.	JWY	Class II	2002-04-30
K020568	Akuport M-2	Vibrant Health	GZO	Class II	2002-04-30
K020565	Eav Combi-2	Vibrant Health	GZO	Class II	2002-04-30
K020564	Eav Kindling 2000S Gsr Device	Virbrant Health	GZO	Class II	2002-04-30
K020366	Global ECG Management System (Gems)	Cardiocomm Solutions, Inc.	DPS	Class II	2002-04-30
K020350	Bci 3180 Pulse Oximeter	Bci, Inc.	DQA	Class II	2002-04-30
K020314	Digi-Pro TENS, Model Wl-2204 and Wl-2205	Well-Life Healthcare Limited	IPF	Class II	2002-04-30
K020210	Glucometer Dex Blood Glucose System (Modified)	Bayer Group Diagnostics	NBW	Class II	2002-04-30
K012279	Patton Tripol	Patton Medical Corp.	GEI	Class II	2002-04-30
K021155	Mas Ua Control, Dade Ua Control- Liquid Assayed Urinalysis Control	Medical Analysis Systems, Inc.	JJW	Class I	2002-04-29
K021055	Busse Umbilical Cord Clamp Cutter	Busse Hospital Disposables	HFW	Class II	2002-04-29
K020911	Mid Labs Autonomous Vit Enhancer (Ave)	Medical Instrument Development Laboratories, Inc.	HQE	Class II	2002-04-29
K020894	Calibrating Material, Cal-Pak, Buffers	Mission Diagnostics	JIT	Class II	2002-04-29
K020748	Etest Ertapenem	Ab Biodisk	JWY	Class II	2002-04-29
K020530	Evans Sub-Q, Model Mc4206	Evans Medical, Inc.	FPA	Class II	2002-04-29