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 2026-10-29, 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 929 of 3530

510(k) clearances, page 929 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K111908	Biomet Microfixation Sternal Closure System	Biomet Microfixation	HWC	Class II	2011-11-29
K111272	Rhausler Plage Anterior Cervical Fusion System	Rhausler, Inc.	OVE	Class II	2011-11-29
K111087	Foundation	Olympus Terumo Biomaterials Corporation	LYC	Class II	2011-11-29
K102756	Surecore Biopsy Device	Chest Innovations, Inc.	KNW	Class II	2011-11-29
K113241	Bd Emerald Single Use, Hypodermic Syringe	Becton Dickinson & Co	FMF	Class II	2011-11-28
K113198	Nmi Control Syringe, 7 Ml Nmi Control Syringe, 8 Ml	Boston Scientific Corporation	DXT	Class II	2011-11-28
K113153	Dp-20 and Dp-30 Digital Ultrasonic Diagnostic Imaging System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYO	Class II	2011-11-28
K111891	Synthes Brainlab Trauma Compatible Instruments	Synthes (USA) Products LLC	HSB	Class II	2011-11-28
K110170	Raptor Facet Fixation System	Alphatec Spine, Inc.	MRW	Unclassified	2011-11-28
K112636	Cytoguard(tm) Closed Luer Connector	B.Braun Medical, Inc.	FPA	Class II	2011-11-26
K111342	Light Guide Cable	Schott North America	HBI	Class II	2011-11-25
K113280	Carotid Coil Ge 1.5T	Tursiop Technologies, LLC	MOS	Class II	2011-11-23
K113163	Penumbra System Max	Penumbra Inc.	NRY	Class II	2011-11-23
K112751	Sdx-4343Cs	Samsung Mobile Display Co., Ltd.	MQB	Class II	2011-11-23
K112564	Quixie Nebulizer	Odyssey Medical Technologies, LLC	CAF	Class II	2011-11-23
K112488	Hotdog Patient Warming System	Augustine Biomedical & Design, LLC	DWJ	Class II	2011-11-23
K112150	Profemur Gladiator Ha Hip Stem	Wrightmedicaltechnologyinc	KWA	Class III	2011-11-23
K111748	Recovery+ Model Ps 511, Dvtherapy Model Ps 511A	Joy Long	JOW	Class II	2011-11-23
K111242	Magnetom Aera and Magnetom Skyra	Siemens Medical Solutions USA, Inc.	LNH	Class II	2011-11-23
K111119	Trabecular Metal (Tm) Fusion Device	Zimmer Spine, Inc.	ODP	Class II	2011-11-23
K110619	Architect 25-Oh Vitamin D 100T, Vitamin D 500T, Vitamin D Calibrators, Vitamin D Controls	Biokit, S.A.	MRG	Class II	2011-11-23
K110605	Rom Plus	Clinical Innovations, LLC	NQM	Class I	2011-11-23
K110525	Vitalograph Model 7100 - Vitalojak	Vitalograph Ireland Ltd.	DSH	Class II	2011-11-23
K103803	Hamilton-G5	Hamilton Medical AG	CBK	Class II	2011-11-23
K103483	Ingenuity Tf Pet/mr	Philips Healthcare (Cleveland)	OUO	Class II	2011-11-23
K102644	Advia 2120 with Autoslide System, and Advia 2120I	Siemens Healthcare Diagnostics Inc.	GKZ	Class II	2011-11-23
K113139	Lzi Cocaine Metabolite Homogeneous Enzyme Immunoassay,calibrators,controls	Lin-Zhi International Inc	DIO	Class II	2011-11-22
K113052	Infinix-Cci	Toshiba America Medical Systems, In.C	MQB	Class II	2011-11-22
K113027	Syngo Aortic Valveguide Software	Siemens Medical Solutions USA, Inc.	OWB	Class II	2011-11-22
K112999	Dimension Clinical Chemistry System	Siemens Healthcare Diagnostics Inc.	JJE	Class I	2011-11-22
K112963	Td-4257 Blood Glucose Monitoring Systems,td 4257 Multi Blood Glucose Monitoring Systems	Taidoc Technology Corporation	NBW	Class II	2011-11-22
K112784	Renasys Ab Abominal Dressing Kit	Smith & Nephew, Inc.	FTL	Class II	2011-11-22
K112760	Amsco V-Pro Max Low Temperature Sterilization System	STERIS Corporation	MLR	Class II	2011-11-22
K112687	Connex(r) Vital Signs Monitor 6000 Series	Welch Allyn Inc	MWI	Class II	2011-11-22
K112647	Bestshape Blood Pressure Monitoring System	Wistron Corporation	DXN	Class II	2011-11-22
K112544	Unimed Blood Pressure Cuff	Unimed Medical Supplies Inc	DXQ	Class II	2011-11-22
K112484	Zavation Spinal System	Zavation	MNI	Class II	2011-11-22
K112380	Clearvision	Midmark Corp	MUH	Class II	2011-11-22
K112273	Accumed Upper Arm Automatic Blood Pressure Monitor	Accumed Healthcare (Shanghai), Inc.	DXN	Class II	2011-11-22
K112270	Accumed Wrist Automatic Blood Pressure Monitor	Accumed Healthcare (Shanghai), Inc.	DXN	Class II	2011-11-22
K112220	Devilbiss Intellipap / Sleepcube Auto Bilevel	Sunrise Medical, Inc.	BZD	Class II	2011-11-22
K112210	Fraxion	3C-Medical Intelligence GmbH	IYE	Class II	2011-11-22
K112134	Truclear Operative Hysteroscope	Smith & Nephew, Inc.	HIH	Class II	2011-11-22
K112015	Premier Hb9210 Hba1c Analyzer	Trinity Biotech (Primus Corporation dba Trinity Biotech)	LCP	Class II	2011-11-22
K111944	Nb3d Bone Void Filler	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	MQV	Class II	2011-11-22
K111690	Devine Spinal System	Changzhou Orthmed Medical Instrument Co., Ltd.	MNH	Class II	2011-11-22
K111066	Migra Tab, Quicksplint Migraine	Migratherapy, LLC	MQC	Unclassified	2011-11-22
K110955	Anyridge Internal Implant System	Megagen Co., Ltd.	DZE	Class II	2011-11-22
K110893	Vtrust Finger Type Pulse Oximeter	Taidoc Technology Corporation	DQA	Class II	2011-11-22
K110427	Femtec Laser System for Capsulotomy	Technolas Perfect Vision GmbH	OOE	Class II	2011-11-22