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 2026-11-05, 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 1352 of 3531

510(k) clearances, page 1352 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K043056	Gore Seamguard Bioabsorbable Staple Line Reinforcement Material	W. L. Gore & Associates, Inc.	FTL	Class II	2004-12-22
K043038	Biotop Hooksafe Luer-Lock Safety Syringe, Models 3Cc/ml, 5Cc/ml and 10Cc/ml	Biotop Technology Co., Ltd.	MEG	Class II	2004-12-22
K042982	Quantex Myoglobin	Instrumentation Laboratory Co.	DDR	Class II	2004-12-22
K042959	Depuy C-Stem Amt Hip Prosthesis	Depuy Orthopaedics Inc.	JDI	Class II	2004-12-22
K042907	Needle Incapacitator (Needle Guard)	Pdmp, Inc.	FMI	Class II	2004-12-22
K042822	Tcm Endo V, Model 1534	Nouvag AG	EKX	Class I	2004-12-22
K042762	Pefakit Apc-R Factor V Leiden	Pentapharm AG	GGW	Class II	2004-12-22
K042760	Pefakit Apc-R Factor V Leiden Controls	Pentapharm AG	GGN	Class II	2004-12-22
K042732	Architect Ca 15-3 Assay	Fujirebio Diagnostics, Inc.	MOI	Class II	2004-12-22
K042631	Ear Thermometer, Model Wl-320X	Innovatech, Inc.	FLL	Class II	2004-12-22
K042603	Gynecare Prolene Fastener System	Ethicon, Inc	PBQ	Class II	2004-12-22
K040971	Genchem Ise Electrolyte Reference	Genchem, Inc.	JGS	Class II	2004-12-22
K033559	12-Lead Glove	Ineedmd	DRX	Class II	2004-12-22
K030400	Neosci Medical Endoluminal Brush	Neosci Medical, Inc.	LJS	Class II	2004-12-22
K043482	The Reliance Pi Process Indicator, Model D5116	STERIS Corporation	JOJ	Class II	2004-12-21
K043455	Sa8000 Se Diagnostic Ultrasound System	Medison Co., Ltd.	IYN	Class II	2004-12-21
K043452	Titan High Resolution Ultrasound System and Sonosite Ultrasound System	FUJIFILM SonoSite,Inc.	IYN	Class II	2004-12-21
K043291	Cardioblate Dispersive Electrode Adapter (Accessory), Model 60884	Medtronic, Inc.	GEI	Class II	2004-12-21
K043280	Mimix Mp Bone Void Filler	Zimmer GmbH	GXP	Class II	2004-12-21
K043232	Ucr Spinal System	Seaspine, Inc.	NKB	Class II	2004-12-21
K043229	Modification to Altius Oct System	Interpore Cross Intl.	KWP	Class II	2004-12-21
K043132	Universal Xacttrace	Medcare Flaga	MNR	Class II	2004-12-21
K043130	Modification to Pajunk Stimulong Plus Catheter Sets	Pajunk GmbH Medizintechnologie	CAZ	Class II	2004-12-21
K043128	Olympus Endoarm	Olympus Corp.	GWG	Class II	2004-12-21
K042979	Modification to: Plexalong Sets	Pajunk GmbH Medizintechnologie	BSP	Class II	2004-12-21
K042871	Trabecular Metal Acetabular Augments, Models 4894-Xxx-Yy, 02-212-105Xx3, 02-212-205Xx3, 02-212-305Xx3	Zimmer Trabecular	LPH	Class II	2004-12-21
K042841	M2a/c2a Acetabular System	Zimmer GmbH	JDL	Class III	2004-12-21
K042825	Accudrain External Csf Drainage System	Integra LifeSciences Corporation	JXG	Class II	2004-12-21
K042789	Vertex Reconstruction System	Medtronic Sofamor Danek	KWP	Class II	2004-12-21
K042666	Luth-All Sub-Q Needle Set	Luth-All Medical Products, LLC	FPA	Class II	2004-12-21
K042132	Novasys Transurethral RF System	Novasys Medical, Inc.	NVJ	Class II	2004-12-21
K042000	Modified Msq Family of Lovely Light/laser Systems	Msq (M2), Ltd.	GEX	Class II	2004-12-21
K041950	Apex K2 Hip System	VQ Orthocare	LPH	Class II	2004-12-21
K041850	Medallion Modular Hip System	Biomet Manufacturing Corp	LPH	Class II	2004-12-21
K041810	Serfas Energy System	Stryker Corp.	GEI	Class II	2004-12-21
K041038	Churchill Medical Dual Chamber Empty Container	Vygon Mfg	KPE	Class II	2004-12-21
K040487	Trabecular Metal Knee System Augments	Implex Corp.	MBH	Class II	2004-12-21
K033044	Dream Cleanse S Scaler, Dream Compact S Scaler	American Green Dent. Mfg, Inc.	ELC	Class II	2004-12-21
K043412	Modification to: Viewstation	Elekta Limited	LLZ	Class II	2004-12-20
K043244	Fresenius Optiflux F20nr, Ff18nr, F16nr	Fresenius Medical Care Renal Therapies Group, LLC	KDI	Class II	2004-12-20
K043221	Willi Geller Creation Cp Porcelain	Jensen Industries, Inc.	EIH	Class II	2004-12-20
K043159	Powder Free Clear Synthetic Vinyl Examination Gloves, Small, Medium, Large, X-Large	Shijaizhuang Brilliant Ocean Plastic Co., Ltd.	LYZ	Class I	2004-12-20
K043085	Modification to: Pneuton Ventilator	Airon Corporation	CBK	Class II	2004-12-20
K042846	Systemp.link	Ivoclar Vivadent, Inc.	EMA	Class II	2004-12-20
K042079	Oss/(scarf)- and Osw-Screw	O.M.T. Oberflachen-Und Materialtechnologie GmbH	HWC	Class II	2004-12-20
K041658	Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex 2200	Bio-Rad Laboratories Inc.	LKJ	Class II	2004-12-20
K043366	Permacol Surgical Implant	Tissue Science Laboratories, PLC	FTL	Class II	2004-12-17
K043355	Sintea Biotech Posterior Lumbar System with Polyaxial and Recovery Screws, Model Pls.01.t5.x	Sintea Biotech, Inc.	KWP	Class II	2004-12-17
K043320	Modification to Roche Elecsys Folate II Calcheck II	Roche Diagnostics GmbH	JJX	Class I	2004-12-17
K043319	Clareon and Solarus Pulsed Light Devices and Accessories	Novalis Medical, LLC	GEX	Class II	2004-12-17