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 2026-11-02, 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 1028 of 3531

510(k) clearances, page 1028 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K092348	Poly Fit High Hydrating Antimicrobial Dressings	Polyremedy, Inc.	FRO	Unclassified	2010-04-08
K091772	Powder-Free Vinyl Exam Gloves	Shijiazhuang Huijingyuan Plastic Co, Ltd.	LYZ	Class I	2010-04-08
K100662	Femvue Cornual Balloon Catheter	Femasys Inc.	LKF	Class II	2010-04-07
K100597	Harmonic Focus Shears	Ethicon Endo-Surgery Inc	LFL	Unclassified	2010-04-07
K100224	Estech Cobra Bipolsr II	Endoscopic Technologies, Inc. D/B/A Estech	GEI	Class II	2010-04-07
K100215	Archimed Remedy Cervical Plate	Archimed, Inc.	KWQ	Class II	2010-04-07
K094041	Alpha Orthopaedics At3 System	Alpha Orthopaedics	GEI	Class II	2010-04-07
K093845	Ethicon Securestrap 5Mm Absorbable Strap Fixation Device, Model Strap25	Ethicon, Inc	GDW	Class II	2010-04-07
K093441	Dimension Vista Loci Digoxin Flex Reagent Cartridge (Digxn), Model K6435	Siemens Healthcare Diagnostics Inc.	KXT	Class II	2010-04-07
K093279	Navix Access Device	Xlumena, Inc.	GCJ	Class II	2010-04-07
K093243	Coagusense Self-Test Prothrombin Time/inr Monitoring System	Coagusense Inc	GJS	Class II	2010-04-07
K092984	Panpac Uterine Inector, Model Ui-4.0, Ui-2.0	Panpac Medical Corporation	LKF	Class II	2010-04-07
K092765	Lanx Anterior Plating System	Lanx, Inc.	KWQ	Class II	2010-04-07
K091791	Provant System, Model 4201	Regenesis Biomedical Inc	ILX	Class II	2010-04-07
K090845	Apex Arc Hip Stem	Omni Life Science, Inc.	LZO	Class II	2010-04-07
K100692	Digital Spot Mammography System	Hologic, Inc.	IZH	Class II	2010-04-06
K100673	Easylyte Na/k/cl/li Analyzer, Model 2020	Medica Corp.	JGS	Class II	2010-04-06
K100419	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Tangshan Yongkang Glove Co., Ltd.	LYZ	Class I	2010-04-06
K093913	Mercury Medical T-Piece Resuscitator	Mercury Medical	BTL	Class II	2010-04-06
K093176	Med-Lok	Sta-Med, LLC	MEG	Class II	2010-04-06
K091770	Vinyl Patient Exam Gloves Pre-Powered, Clear	Shijiazhuang Huijingyuan Plastic Co, Ltd.	LYZ	Class I	2010-04-06
K100670	S-Scan, Model 9800020010	Esaote S.p.A.	MOS	Class II	2010-04-05
K100599	Cas Fixation Pin 3.2 Dia X 180 Mm Str, Cas Fixaton Pin 3.2 Dia X 80 Mm Str, Cas Fixaton Pin 3.2 Dia X 150 Mm	Orthosoft, Inc.	OLO	Class II	2010-04-05
K100164	Mr Inspire with Extended Kit	Paramed S.r.l.	LNH	Class II	2010-04-05
K100023	Profile-V Medtoxscan Drugs of Abuse Test System and 12 Drugs Test System	MEDTOX Diagnostics, Inc.	DJG	Class II	2010-04-05
K093935	Smith & Nephew Footprint Rcx Pk Suture Anchor	Smith & Nephew, Inc.	MBI	Class II	2010-04-05
K093790	Simondr Drp	Simondr, Inc.	MQB	Class II	2010-04-05
K093632	Infinity Acute Care System Workstation Neonatal Care	Drager Medical AG & Co. KGaA	CBK	Class II	2010-04-05
K093371	Model Dgh 6000 Scanmate a	DGH Technology, Inc.	IYO	Class II	2010-04-05
K093341	Century Model 105C	Sybron Dental Specialties, Inc.	EFB	Class I	2010-04-05
K092578	Lifeglobal Protein Supplement	<Genx> Intl., Inc.	MQL	Class II	2010-04-05
K092387	Medivators Dsd Edge Endoscope Reprocessing System	Medivators Inc	FEB	Class II	2010-04-05
K090036	System 1.5 Sterile Processing System	STERIS Corporation	MED	Class II	2010-04-05
K083312	Minihip Stem	Corin USA	LZO	Class II	2010-04-05
K100230	Smoothshapes System, 11318-120V, 11319-230V	Eleme Medical, Inc.	NUV	Class II	2010-04-02
K100120	Alexis Orthopaedic Wound Retractor	Applied Medical Resources Corp	KGW	Class II	2010-04-02
K093858	Psa Cable, Models 4160 and 4161 and Psa Cable Adapter, Model 4053A	St. Jude Medical, Cardiac Rhythm Management Divisi	DSA	Class II	2010-04-02
K093706	Proxiscan Model 101	Hybridyne Imaging Technologies, Inc.	IYX	Class I	2010-04-02
K093555	Cobas U411 Test System	Roche Diagnostics GmbH	KQO	Class I	2010-04-02
K093333	Primus Steam Sterilizer Pss8-Aa (16X16x26 Multi Functional Sterilizer), Lab/lo Sterilizer,primus Steam Sterilizer Pss8	PRIMUS Sterilizer Company LLC	FLE	Class II	2010-04-02
K093321	Biohorizons Laser-Lok 3.0 Implant System	BioHorizons Implant Systems Inc	DZE	Class II	2010-04-02
K093305	Enhanced Ultra Vit Probe	Alcon Laboratories	MLZ	Class II	2010-04-02
K093135	Venner Pneux P.y. (Tm) Tracheostomy Tube and Endo Tracheal Tube	Venner Medical (Singapore) Pte Ltd	BTR	Class II	2010-04-02
K092785	Combined Vasomedical-Biox Ambulatory ECG & Blood Pressure Recorder & Analysis Software, 2301	Vasomedical, Inc.	DSH	Class II	2010-04-02
K092579	Intrauterine Insemination (Iui) Catheter	Fertiligent, Ltd.	MQF	Class II	2010-04-02
K092530	Sprytie, Models St001, St002 and St003	Russell B. Walther	DZK	Class II	2010-04-02
K092484	Heliox Low Flow Sentry Blender	Cardinal Health 207, Inc.	BZR	Class II	2010-04-02
K092481	Hemodialysis Carbon Exchange, Dual Bed Deionizer Exchange, Mixed Bed Deionizer Exchange, Model .60Maw,1.2maw,3.6maw, 1.2	New Aqua, LLC (dba Aqua Systems)	FIP	Class II	2010-04-02
K092076	Aegis & Aegis II Spinal System	Corentec Co., Ltd.	MNI	Class II	2010-04-02
K091955	Stryker Sonicpin System	Howmedica Osteonics Corp	HTY	Class II	2010-04-02