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 974 of 3531

510(k) clearances, page 974 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K103134	Fukuda Denshi	Fukuda Denshi USA, Inc.	MHX	Class II	2011-03-11
K102919	Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous Hardshell Carsiotomy Reservoir, Neonatal Venous Hardshe	MAQUET CARDIOPULMONARY GmbH	DTN	Class II	2011-03-11
K102821	Discovred	Phoenix Dental, Inc.	LFC	Class II	2011-03-11
K102692	Sms Gowns (Reinforced and Reinforced with Guider), Spunlace Gowns (Regular, Regular with Guider), Spunlace Gowns (Reinfo	Hangzhou Jincheng Medical Supplier Manufacture Co.	FYA	Class II	2011-03-11
K102515	Np15	Weinmann Gerate Fur Medizin GmbH + Co. KG	BZD	Class II	2011-03-11
K102102	Computed Tomography X-Ray System	Vatech Co., Ltd.	JAK	Class II	2011-03-11
K101913	Anthofit Oi, Anthofit He, Ossfit and Axiom	Anthogyr SAS	DZE	Class II	2011-03-11
K101608	Biomet 3I Patient Specific Dental Abutments-Encode Abutments	ZimVie US Corp LLC	NHA	Class II	2011-03-11
K101607	Biomet 3I Patient Specific Dental Abutments - Encode Abutments	ZimVie US Corp LLC	NHA	Class II	2011-03-11
K101458	Lina Xcise Model Mor-1515	LiNA Medical Inc	HET	Class II	2011-03-11
K100569	Merit Embolectomy Catheter Model Asap100	Merit Medical Systems, Inc.	QEZ	Class II	2011-03-11
K110503	Airstrip Remote Patient Monitoring (Rpm)	AirStrip Technologies, Inc.	MWI	Class II	2011-03-10
K103709	Ceracell Dental	Curasan AG	LYC	Class II	2011-03-10
K103537	Et III Sa Ultra Wide System	Hiossen, Inc.	DZE	Class II	2011-03-10
K103479	Novel Tapered Hip Stem	Stryker Corp.	MEH	Class II	2011-03-10
K103123	Apex Pointer+; Measruing Cable, Hook, Lip Clip, Touch Probe (Accessories)	Micro-Mega Societe Anonyme	LQY	Unclassified	2011-03-10
K103053	Verify 270Fp Challenge Pack	STERIS Corporation	JOJ	Class II	2011-03-10
K102704	Easy Cuff	Joan Spiegel, MD	BSK	Class II	2011-03-10
K093736	Depuy Corail Hip System, Revision Stem	Depuy Orthopaedics Inc.	LZO	Class II	2011-03-10
K092433	Dysis	Forth Photonics Hellas SA	HEX	Class II	2011-03-10
K103649	Voluson S6, Voluson S8	GE Healthcare	IYN	Class II	2011-03-09
K103518	Trinity Acetabular System	Corin USA	LWJ	Class II	2011-03-09
K110361	Zoll R Series with 2010 Aha Guidelines Software Update	ZOLL Medical Corporation	MKJ	Class III	2011-03-08
K103191	Quadrox-I Pediatric Microporous Membrane Oxygenator with Integrated Arterial Filter with Softline / Bioline Coating	MAQUET CARDIOPULMONARY GmbH	DTZ	Class II	2011-03-08
K101901	Ipl Therapy System	Beijing Starlight Science & Technology Development Co., Ltd.	ONF	Class II	2011-03-08
K103480	Thoracic Vcar	GE Healthcare	LLZ	Class II	2011-03-07
K103400	Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube Clip	Stryker Corp.	OLO	Class II	2011-03-07
K103335	Gem Option for 1.5 MRI Systems	GE Healthcare	MOS	Class II	2011-03-07
K103169	Aleuttian	K2M, Inc	ODP	Class II	2011-03-07
K102964	EU-Ttg Iga and EU-Ttg Igg	Grifols USA, LLC.	MVM	Class II	2011-03-07
K102574	Palla M Spinal System	Korea Bone Bank Co., Ltd.	MNH	Class II	2011-03-07
K102064	Bd Facs Sample Prep Assistant III (Spa III)	Becton Dickinson & Co	GKZ	Class II	2011-03-07
K101985	Asahi Guide Wire Extension 165Cm	Asahi Intecc Co., Ltd.	DQX	Class II	2011-03-07
K101854	Advia Chemistry Glucose Hexokinase_3 (Gluh_3) Reagent, Models Ref 05001429	Siemens Healthcare Diagnostics Inc.	CFR	Class II	2011-03-07
K101790	Quantum Spinal System, Quantum Mis	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	NKB	Class II	2011-03-07
K101250	Given Pillcam Platform with Pillcam Sb Capsules	Given Imaging Ltd.	NEZ	Class II	2011-03-07
K100928	Micro Diary Spirometer	ZOLL Palm Springs	BZG	Class II	2011-03-07
K100370	Symmetric Total Knee Aguments	Whiteside Biomechanics, Inc.	JWH	Class II	2011-03-07
K110393	Ekf- Diagnostic Hemo_control Hemoglobin Measurement System; Ekf-Diagnostic Hemoglobin Microcuvettes (Modified Curvette W	Ekf Diagnostic GmbH	GKR	Class II	2011-03-04
K110354	4.5Mm Va-Lcp Curved Condylar Plate System	Synthes (USA) Products LLC	JDP	Class II	2011-03-04
K110322	Olecra Intramedullary Fixation System	Mylad Orthopedic Solutions, LLC	HSB	Class II	2011-03-04
K110145	Biomet Sports Medicine Juggerknot Soft Anchor	Zimmer GmbH	MBI	Class II	2011-03-04
K103792	Barco Mammo Tomosynthesis	Barco N.V.	LLZ	Class II	2011-03-04
K103687	Synapse 3D Cerebral Analysis	FUJIFILM Healthcare Americas Corporation	LLZ	Class II	2011-03-04
K103682	Parietex Progrip	Sofradim Production	FTL	Class II	2011-03-04
K103585	Bosworth Aegis Liner & Restorative Material W/acp	Harry J. Bosworth Co.	EMA	Class II	2011-03-04
K103497	Ceramic Femoral Head	United Orthopedic Corp.	MEH	Class II	2011-03-04
K103458	Viewpoint 6	GE Healthcare	LLZ	Class II	2011-03-04
K103292	Trio Trauma Spinal System	Stryker Corp.	NKB	Class II	2011-03-04
K103206	Raumedic- Icp-Monitoring System	Raumedic AG	GWM	Class II	2011-03-04