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 1027 of 3531

510(k) clearances, page 1027 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K092472	Non Sterile Powder-Free, Natural or Aqua Lano-E Nitrile Examination Gloves, with or without Citrus/ Peppermint Scent	Ascend Eagle, Inc.	LZA	Class I	2010-04-15
K092198	Cormet Cementless Resurfacing Femoral Head	Corin USA	KXA	Class II	2010-04-15
K090744	Claro	Clrs Technology Corporation	OLP	Class II	2010-04-15
K100881	Synapse Obliquus Mip/mpr/fusion	FUJIFILM Healthcare Americas Corporation	LLZ	Class II	2010-04-14
K100747	Contrex Plus Low Control Solution	Apex Biotechnology Corp.	JJX	Class I	2010-04-14
K100362	Cambridge Heart Oem	Cambridge Heart, Inc.	DQK	Class II	2010-04-14
K100272	Intellivue Clinical Information Portfolio	Philips North America LLC	DXJ	Class II	2010-04-14
K100108	Amedica Drug Test Thc, Coc, Opi, Amp, Met, Pcp, Bar, Bzo, Mdma, Oxy, Tca	Amedica Biotech, Inc.	NGL	Class II	2010-04-14
K100104	Hybernite Rainout Control System	Plastiflex Group NV	BZE	Class II	2010-04-14
K093907	Welch Allyn Non Invasive Blood Pressure (Nibp) Device	Welch Allyn Inc	DXN	Class II	2010-04-14
K093904	Glenveigh Vaginal Tamponade Balloon Catheter	Glenveigh Surgical, LLC	KNA	Class II	2010-04-14
K093746	Verilast Wear Claims for the Legion Primary Knee System	Smith & Nephew, Inc.	JWH	Class II	2010-04-14
K093361	Synthes Air Pen Drive (Apd) System	Synthes (USA) Products LLC	HBB	Class II	2010-04-14
K090301	Binaxnow Pbp2a Test, Model 890-000	Binax, Inc.	MYI	Class II	2010-04-14
K100392	Powder-Free Vinyl Patient Examination Gloves	Tangshan Jiaxing Plastic Products Co., LT	LYZ	Class I	2010-04-13
K100145	A&e Zirconia Blanks Model Ezbuct02, Ezbuct04, Ezbuct25, Ezbuct31, Ezbust07, Ezbust08, Ezbutt05, Ezbutt06	A&E Bioceramic Co., Ltd.	EIH	Class II	2010-04-13
K093697	Vashe Wound Therapy Solution	Puricore, Inc.	FRO	Unclassified	2010-04-13
K093695	Peak Plasmablade 3.Os Tissue Dissection Device	Peak Surgical, Inc.	GEI	Class II	2010-04-13
K093554	Retroflex Dilator Kit	Edwards Lifesciences LLC	DRE	Class II	2010-04-13
K092521	Zuma-C	Seaspine, Inc.	OVE	Class II	2010-04-13
K100892	Renegade Hi-Flo Fathom Kit Model M001182xxx	Boston Scientific Corporation	KRA	Class II	2010-04-12
K100737	Modification to: Trio+spinal Fixation System	Howmedica Osteonics Corp	NKB	Class II	2010-04-12
K100384	Fiberlase C02 Laser Waveguide	Lumenis Ltd	GEX	Class II	2010-04-12
K100111	Ncb Periprosthetic Femur Polyaxial Locking Plate System	Zimmer GmbH	HRS	Class II	2010-04-12
K100084	Multi Frame Wheelchair	R82 a/S	IOR	Class I	2010-04-12
K100081	Enteroscopy Overtube, Model 00712140	United States Endoscopy Group, Inc.	FED	Class II	2010-04-12
K092066	Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01), Phaser Waste Collection Kit (Was-01), Phaser Cannulae	Andrew Technologies, LLC	QPB	Class II	2010-04-12
K091022	Modification to Resert Xl Hld High Level Disinfectant	STERIS Corporation	MED	Class II	2010-04-12
K090975	Deroyal Non-Locking Bone Fixation System	DeRoyal Industries, Inc.	HRS	Class II	2010-04-12
K100683	Neurolink Ip Model: Pk1117	Natus Medical Incorporated	GWQ	Class II	2010-04-09
K100284	Liquiband Ultima, Lut 003	Medlogic Global Limited	MPN	Class II	2010-04-09
K100264	T-Form Extremity Immobilizer, Model Rt-6060	Bionix Development Corp.	IYE	Class II	2010-04-09
K100252	Master-Vu a-Scan, Mv4500	Sonomed, Inc.	IYO	Class II	2010-04-09
K093932	Ethicon Physiomesh, Flexible Composite Mesh	Ethicon, Inc	FTL	Class II	2010-04-09
K093802	Ultraview Dm3 Monitor	Zoe Medical, Inc.	DXN	Class II	2010-04-09
K092335	Peak Expiratory Flow Meter, Kn-9710	K-Jump Health Co., Ltd.	BZH	Class II	2010-04-09
K091720	Sklarlite Rigid Sterilization Container System	Sklar Corp.	KCT	Class II	2010-04-09
K100701	Smartest Persona Blood Glucose Test Sytem Model: 6277	Biotest Medical Corp.	NBW	Class II	2010-04-08
K100676	Synthes Tomofix(tm) Meial High Tibia Plate, Small	Synthes (USA) Products LLC	HRS	Class II	2010-04-08
K100417	Xknife 5	Integra Radionics, Inc.	MUJ	Class II	2010-04-08
K100335	Ors Visual	Object Research Systems, Inc.	LLZ	Class II	2010-04-08
K100250	Xceram	Xceramusa	EIH	Class II	2010-04-08
K100046	M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000	Guangdong Biolight Meditech Co., Ltd	MHX	Class II	2010-04-08
K094007	Unicem	3M Espe AG Dental Products	EMA	Class II	2010-04-08
K093806	Myknee Cutting Blocks	Medacta International SA	JWH	Class II	2010-04-08
K093680	Diazyme Cystatin C Assay	Diazyme Laboratories, Inc.	NDY	Class II	2010-04-08
K093394	Bc-3200 Auto Hematology Analyzer,m-30D Diluent, M-30R Rinse, M-30Cfl Lyse, M-30E-Z Cleanser, M-30Probe Cleanser, Bc-3D C	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	GKZ	Class II	2010-04-08
K093288	Cardionet Ambulatory ECG Monitor with Arrhythmia Detection	Cardionet, LLC	QYX	Class II	2010-04-08
K093229	Catheter Connections Dualcap	Catheter Connections, Inc.	QBP	Class II	2010-04-08
K092351	Poly Fit + Absorbing and High Absorbing Antimicrobial Dressings	Polyremedy, Inc.	FRO	Unclassified	2010-04-08