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 1986 of 3531

510(k) clearances, page 1986 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K960737	Model 555 010 Xy Conversion(55010)	Systems Supply Services, Inc.	KPQ	Class II	1996-05-22
K960728	One Step Connect Leads (Quattrode, Octrode, Cervitrode)	Neuromed, Inc.	GZB	Class II	1996-05-22
K960446	Model 5471 & 5471L Sterile Disposable Patient Cable Assemblies	Medtronic, Inc.	DSA	Class II	1996-05-22
K955736	Stim-8	Bmr, Ltd.	IPF	Class II	1996-05-22
K955072	Laminaria	Cti Corp., Ltd.	HDY	Class II	1996-05-22
K954847	Disco Uterine Contraction Transducer & Accessories	Ocg Systems, Inc.	HFM	Class II	1996-05-22
K954818	Consensus Posterior Stabilized Knee	U.S. Medical Products, Inc.	JWH	Class II	1996-05-22
K954402	Et-Tube Placement Detector (with Colibri Indicator)	Icor AB	CCK	Class II	1996-05-22
K952417	Quest Exercise Stress System	Burdick Corp.	DSI	Class II	1996-05-22
K951461	Nci-H292 Cell Culture	Viromed Laboratories, Inc.	KIR	Class I	1996-05-22
K951440	Llc-Mk2 (Monkey Kidney, Macaca Mulata) Cell Culture	Viromed Laboratories, Inc.	KIR	Class I	1996-05-22
K931220	Spermicidal Lubricated Condom	Monsys USA, Inc.	LTZ	Class II	1996-05-22
K961428	Soft-55 Daily Wear Contact Lens	Lombart Lenses, Ltd.	LPL	Class II	1996-05-21
K961085	Deroyal Wound Care Multidex Plus Gel Wound Dressing	Debusk Knitting Mills, Div. Deroyal Industries	MGQ	Unclassified	1996-05-21
K960718	Lrm	Lake Region Mfg., Inc.	DQX	Class II	1996-05-21
K960705	Guglielmi Detachable Coil	Target Therapeutics	HCG	Class II	1996-05-21
K960631	Medtronic Model 3550 Accessory Kit (Contents) 3550-Ox	Medtronic, Inc.	GZF	Class II	1996-05-21
K960433	Vst-10, Vst-10/2	Vcare Intl., Inc.	IPF	Class II	1996-05-21
K955248	u.s. Endoscopy Pull Peg Kit & u.s. Endoscopy Guidewire Peg Kit	United States Endoscopy Group, Inc.	KNT	Class II	1996-05-21
K953940	Terumo Retractable Needle (Rn) Syringe	Terumo Medical Corp.	FMF	Class II	1996-05-21
K953686	Helisal Rapid Blood Test	Cortecs, Ltd.	LYR	Class I	1996-05-21
K946268	Bactec(r) 9000Tb System	Becton Dickinson Diagnostic Instrument Systems	MDB	Class I	1996-05-21
K961559	Sas Shigella Dysenteriae Type 9 Antiserum	SA Scientific, Ltd	GNB	Class II	1996-05-20
K961558	Sas Shigella Flexneri Type 3 Antiserum	SA Scientific, Ltd	GNB	Class II	1996-05-20
K961556	Sas Shigella Flexneri Type 1 Antiserum	SA Scientific, Ltd	GNB	Class II	1996-05-20
K961554	Sas Shigella Boydii Type 10 Antiserum	SA Scientific, Ltd	GNB	Class II	1996-05-20
K961553	Sas Shigella Dysenteriae Type 1 Antiserum	SA Scientific, Ltd	GNB	Class II	1996-05-20
K961551	Sas Shigella Dysenteriae Type 2 Antiserum	SA Scientific, Ltd	GNB	Class II	1996-05-20
K961549	Sas Shigella Flexneri Type 2 Antiserum	SA Scientific, Ltd	GNB	Class II	1996-05-20
K961548	Sas Shigella Boydii Type 15 Antiserum	SA Scientific, Ltd	GNB	Class II	1996-05-20
K961547	Sas Shigella Boydii Type 14 Antiserum	SA Scientific, Ltd	GNB	Class II	1996-05-20
K961546	Sas Shigella Boydii Group C1/c1 (8-10) Antiserum	SA Scientific, Ltd	GNB	Class II	1996-05-20
K961543	Sas Shigella Boydii Type 9 Antiserum	SA Scientific, Ltd	GNB	Class II	1996-05-20
K961542	Sas Shigella Flexneri Type 4 Antiserum	SA Scientific, Ltd	GNB	Class II	1996-05-20
K961541	Sas Shigella Boydii Type 8 Antiserum	SA Scientific, Ltd	GNB	Class II	1996-05-20
K961540	Sas Shigella Sonnei Group D Antiserum	SA Scientific, Ltd	GNB	Class II	1996-05-20
K961539	Sas Shigella Dysenteriae Type 10 Antiserum	SA Scientific, Ltd	GNB	Class II	1996-05-20
K961538	Sas Shigella Dysenteriae Type 8 Antiserum	SA Scientific, Ltd	GNB	Class II	1996-05-20
K961535	Sas Shigella Dysenteriae Group A1 (8-10) Antiserum	SA Scientific, Ltd	GNB	Class II	1996-05-20
K961534	Sas Shigella Sonnei Form I Antiserum (3/100/1000Ml)	SA Scientific, Ltd	GNB	Class II	1996-05-20
K961533	Sas Shigella Flexneri Type 6 Antiserum	SA Scientific, Ltd	GNB	Class II	1996-05-20
K961532	Sas Shigella Flexneri Type 5 Antiserum	SA Scientific, Ltd	GNB	Class II	1996-05-20
K961531	Sas Shigella Boydii Type 13 Antiserum	SA Scientific, Ltd	GNB	Class II	1996-05-20
K961529	Sas Shigella Boydii Type 12 Antiserum	SA Scientific, Ltd	GNB	Class II	1996-05-20
K961528	Sas Shigella Boydii Type 11 Antiserum (3/100/1000Ml)	SA Scientific, Ltd	GNB	Class II	1996-05-20
K961352	285 Sl	Argen Precious Metals, Inc.	EJT	Class II	1996-05-20
K960990	Etest Submission for Vancomycin	Ab Biodisk	JWY	Class II	1996-05-20
K960989	Etest Submission for Imipenem	Ab Biodisk	JWY	Class II	1996-05-20
K960979	Screw Extraction Device and Thread Cleaning Tap	Steri-Oss, Inc.	DZE	Class II	1996-05-20
K960920	Clinix Mp	Philips North America LLC	OWB	Class II	1996-05-20