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 1970 of 3531

510(k) clearances, page 1970 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K960398	Steri-Oss Apical Implant	Steri-Oss, Inc.	DZE	Class II	1996-08-01
K960293	Mrtoflm Computer Program	Northwest Medical Physics Equipment, Inc.	IYE	Class II	1996-08-01
K960257	N Antiserum to C1 Inhibitor	Behring Diagnostics, Inc.	DBA	Class II	1996-08-01
K960109	Quantitative Sentinel System	Quantitative Medicine, Inc.	HGM	Class II	1996-08-01
K955534	Seque Infusion Catheter (S-25,30,35,40,45,50,60)	International Innovations, Inc.	KRA	Class II	1996-08-01
K955514	Sharps Safe 1.5 & Sharps Safe 2.0	Dura-Vac Products	MMK	Class II	1996-08-01
K962489	Chromolize Tpa Assay Kit	Medical Diagnostic Technologies, Inc.	GGP	Class II	1996-07-31
K962387	Olympus Fg-45/46-1 Grasping Forceps(urology)	OLYMPUS Corporation of the Americas	FFL	Class II	1996-07-31
K962332	Tens/fes/nmes Electrodes	Uni-Patch, Inc.	GZJ	Class II	1996-07-31
K962273	Malleable Stylet 18 Cm Me1816st, 23 Cm Me1816nst	Marlo Surgical Technology	MFD	Class II	1996-07-31
K962166	Origen Analyzer	Igen, Inc.	JJQ	Class I	1996-07-31
K962079	Humidifier Adapter	Automatic Liquid Packaging, Inc.	BTT	Class II	1996-07-31
K961977	Kendall Sher-I-Bronch Endobrochial Tube	Kendall Healthcare Products Co. Div.Of Tyco Health	CBI	Class II	1996-07-31
K961871	Flourospot T.o.p.	Siemens Medical Solutions USA, Inc.	LLZ	Class II	1996-07-31
K961802	Preclude Synbloc Membrane	W. L. Gore & Associates, Inc.	GXO	Class II	1996-07-31
K961777	Accutrac Xt Intravascular Guide Wire (Floppy) Model 2403/(Flex) Model 2404	Cardio Metrics, Inc.	DQX	Class II	1996-07-31
K961735	Acta	Satelec	EBZ	Class II	1996-07-31
K961706	P1r Plasma Treatment Set for Use in Plasmapheresis with the Fresenius As104 Cell Separator	Fresenius USA, Inc.	LKN	Unclassified	1996-07-31
K961689	Infinet	Infimed, Inc.	LMD	Class I	1996-07-31
K961438	Ballon Dilatation Catheter	Boston Scientific Corporation	KNQ	Class II	1996-07-31
K961014	Quinton Model Q710 Exercise and Resting Electrocardiograph	Quinton, Inc.	LOS		1996-07-31
K960925	Northeast Monitoring Dr180	North East Monitoring, Inc.	DSH	Class II	1996-07-31
K960231	Sphincterotome	Lighthouse Medical, Inc.	KNS	Class II	1996-07-31
K960230	Snare	Lighthouse Medical, Inc.	FDI	Class II	1996-07-31
K960006	C.a.t.s. Continuous Autotransfusion System	Fresenius AG	CAC	Class II	1996-07-31
K955762	Packpd Peritoneal Dialysis Urea Kinetic Modeling Software Program	Fresenius USA, Inc.	KPF	Class II	1996-07-31
K952030	Loop/square Electrode	E & M Engineering, Inc.	HGI	Class II	1996-07-31
K962555	Olympus Fb Series Biopsy Forceps	OLYMPUS Corporation of the Americas	EOQ	Class II	1996-07-30
K962445	Arthrocare Dental Electrosurgery System	ArthroCare Corporation	EKZ	Class II	1996-07-30
K962194	Mli Soft Tissue Screw & Washer System	Medicinelodge, Inc.	MBI	Class II	1996-07-30
K962077	Bard Biopty-Cut Biopsy Needle/with Spacer	C.R. Bard Inc	KNW	Class II	1996-07-30
K961886	Drager Gemina Wall-Mounted Workplace	Alm Surgical Equipment, Inc.	FQO	Class I	1996-07-30
K961693	Dale Gastrostomy Tube Holder	Dale Medical Products, Inc.	PLI	Class II	1996-07-30
K961679	Transvenous, Permanent Tined Target Tip Pacing Leads/transvenous, Permanent Screw-in Pacing Leads	Medtronic, Inc.	DTB	Class III	1996-07-30
K961221	Pylori Igg Elisa Test System	Armkel, LLC	LYR	Class I	1996-07-30
K960980	Isolette Infant Incubator	Air-Shields, Inc.	FMZ	Class II	1996-07-30
K955143	Rpr Liquid Controls	Remel, L.P.	GMP	Class II	1996-07-30
K962736	Mill-Rose Laryngoscopic Injection Needle	Mill-Rose Laboratory	EOQ	Class II	1996-07-29
K962521	Factplus One Step Pregnancy Test	Direct Access Diagnostics	LCX	Class II	1996-07-29
K962407	N/t Protein Control Py	Behring Diagnostics, Inc.	GIL	Class II	1996-07-29
K962254	Nhmc Urethral Catheterization Tray	National Healthcare Mfg. Corp.	FCM	Class II	1996-07-29
K961931	Plain Gut & Chronic Gut Absorbable Surgical Sutures Usp	R. K. Medical L. L. C.	GAL	Class II	1996-07-29
K961925	Polyester Nonabsorbable Surgical Sutures Usp	R. K. Medical L. L. C.	GAT	Class II	1996-07-29
K961773	Protec Sterile Gauze Sponge	Derivadas Degasa S.A. de C.V.	EFQ	Unclassified	1996-07-29
K960247	Ultra Care Powder Free Hypoallergenic Patient Examination Glove	Tillotson Healthcare Corp.	LYY	Class I	1996-07-29
K960225	Powder Free Plus Hypoallergenic (with Labeled Protein Content) Patient Examination Gloves	Tillotson Healthcare Corp.	LYY	Class I	1996-07-29
K955136	Rpr Card Test Kit	Remel, L.P.	GMQ	Class II	1996-07-29
K951264	BIPAP Model S/t-D	Respironics, Inc.	MNT	Class II	1996-07-29
K943207	Nitelife Bi-Level CPAP	Airsep Corp.	BZD	Class II	1996-07-29
K962787	Taki Disposable Acupuncture Needle	Acupuncture Supplies Import Co.	MQX	Class II	1996-07-26