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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 773 of 3530

510(k) clearances, page 773 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K141091	Raysert Plus Injector	Rayner Intraocular Lenses Limited	MSS	Class I	2014-05-28
K140707	Lifeborne Infant Resuscitator	International Biomedical, Ltd.	BTL	Class II	2014-05-28
K140509	Biomet Side Access Distal Femoral Expandable	Biomet Manufacturing Corp	KRO	Class II	2014-05-28
K140334	Xgeo Gc80	Samsung Electronics Co., Ltd.	KPR	Class II	2014-05-28
K140332	Xgeo Gu60a	Samsung Electronics Co., Ltd.	KPR	Class II	2014-05-28
K140139	Clearviewhd	Clearview Diagnostics, Inc.	LLZ	Class II	2014-05-28
K140127	Ferrofibre Stainless Steel Suture with Crimp	Pontis Orthopaedics, LLC	GAQ	Class II	2014-05-28
K133956	Nitrile Powder Free Examination Glove with Colloidal Oatmeal Usp Skin Protectant Drug - White / Dawn Blue / Lemon Green	Hartalega Sdn Bhd	LZA	Class I	2014-05-28
K133953	Latex Powder Free Examination Gloves with Colloidal Oatmeal Usp Skin Protectant Drug with Protein Labeling Claim of 50 M	Hartalega Sdn Bhd	LYY	Class I	2014-05-28
K133776	A-Dec/w&h Electric Handpiece Motor	A-dec, Inc.	EBW	Class I	2014-05-28
K133481	Sjm Confirm Implantable Cardiac Monitor (Icm)	Abbott Medical	MXC	Class II	2014-05-28
K133316	Spirol Block (19 Ga. Open End Models), (20 Ga. Open End Models), (19 Ga. Closed End Models), (20 Ga. Closed End Models)	Epimed International, Inc.	BSO	Class II	2014-05-28
K133071	Elastic Impression Material	Rizhao Huge Dental Industry Co., Ltd.	ELW	Class II	2014-05-28
K132801	Immulite 2000 Systems 3Gallergy Specific Ige Assay	Siemens Healthcare Diagnostics Inc.	DHB	Class II	2014-05-28
K132416	Rehastim 2, Erigopro (Fes)	Hasomed GmbH	GZI	Class II	2014-05-28
K131781	Clearview Total	Clinical Innovations, LLC	LKF	Class II	2014-05-28
K130017	Valentine Steel Wheelchair	Valentine Intl. Ltd.	IOR	Class I	2014-05-28
K140709	Skyhawk Interbody Fusion System	Orthofix SRL	MAX	Class II	2014-05-27
K140423	Itotal Cruciate Retaining (Cr) Knee Replacement System	ConforMIS, Inc.	JWH	Class II	2014-05-27
K140038	Digimatch Orthodoc Robodoc Encore Surgical System	Curexo Technology Corporation	OJP	Class II	2014-05-27
K132744	Acessa Guidance System	Halt Medical, Inc.	HFG	Class II	2014-05-27
K141131	Tightrail Mini	Spectranetics Corp.	DRE	Class II	2014-05-23
K141067	Vivid T8/vivid T8 Pro	GE Healthcare	IYN	Class II	2014-05-23
K140729	Aplio Artida, V3.2	Toshiba America Medical Systems, In.C	IYN	Class II	2014-05-23
K140630	Wallflex Biliary Rx Stent System	Boston Scientific Corporation	FGE	Class II	2014-05-23
K140548	Corcam Heart Monitor	Corcam Technologia, SA	DSI	Class II	2014-05-23
K140384	Fmwand Handpiece Se	Omni-Guide Holdings, Inc.	GEI	Class II	2014-05-23
K133694	Sherpa Pak Transporter	Paragonix Technologies Inc.	KDN	Class II	2014-05-23
K133405	Minnie	Elettronica Valseriana SRL	GEI	Class II	2014-05-23
K133173	Rusch Tracflex Plus Pediatric Tracheostomy Tube Set	Teleflexmedical, Inc.	JOH	Class II	2014-05-23
K133057	Vibralung Acoustical Percussor	Westmed Inc	SDT	Class II	2014-05-23
K132838	Nutra Light Blue	Nutra Luxe MD, LLC	OLP	Class II	2014-05-23
K132788	Myspine Pedicle Screw Placement Guides	Medacta International SA	MNI	Class II	2014-05-23
K132684	Medws Software (Variants Medview, Meddiag, Medmammo)	Medecom SARL	LLZ	Class II	2014-05-23
K123099	Best-AV2 Pro-Sport(tm)	Avazzia, Inc	GZJ	Class II	2014-05-23
K141220	Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument with Sds Software	Thermo Fisher Scientific (Life Technologies Holdin	NSU	Class II	2014-05-22
K140792	Salvation 3Di Plating System	Wrightmedicaltechnologyinc	HRS	Class II	2014-05-22
K140529	Everest Spinal System	K2M, Inc	NKB	Class II	2014-05-22
K140522	Randox Immunoassay Premium Plus Control Levels 1,2 and Level 3 and Immunoassay Premium Plus Tri-Level Control	Randox Laboratories, Limited	JJY	Class I	2014-05-22
K140455	Captia Measles Igm	Trinity Biotech USA	PCL	Class I	2014-05-22
K140454	Navigated Cd Horizon Solera Screwdriver/taps	Medtronic Sofamor Danek USA Inc	OLO	Class II	2014-05-22
K140426	Anthracis Real-Time PCR Assay	Centers for Disease Control and Prevention (CDC)	NHT	Class II	2014-05-22
K140412	Ans1 Software	LD Technology LLC	DXN	Class II	2014-05-22
K140373	Ise Indirect Na, K, C1 for Gen 2	Roche Diagnostics GmbH	JGS	Class II	2014-05-22
K140192	Carpentier Bi-Caval Femoral Cannula	Medtronic, Inc.	DWF	Class II	2014-05-22
K140027	Zimmer Patient Specific Instruments/ System/planner	Materialise N.V.	JWH	Class II	2014-05-22
K133790	Ihealth Align Mini Gluco-Monitoring System	Andon Health Co., Ltd	NBW	Class II	2014-05-22
K133351	Nexus Nis-6P Luer Activated Device	Nexus Medical, LLC	FPA	Class II	2014-05-22
K133269	Zoll X Series	ZOLL Medical Corporation	MKJ	Class III	2014-05-22
K133121	Chito-Sam 100,4In X4in,chito-Sam, 3In X6ft, Chito-Sam 100,3In X10ft, Chito-Sam Active, 4Inx4in,chito-Sam Active, 3Inx6ft	Sam Medical Products	QSY	Unclassified	2014-05-22