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 2234 of 3531

510(k) clearances, page 2234 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K931189	P.f.c. Total Hip System Porous Coated Modular Acet	Johnson & Johnson Orthopaedics, Inc.	LZO	Class II	1994-02-09
K930655	Latex Examination Gloves	Pushpaman Processors, Div. Kanjur Bleaching Co. PV	LYY	Class I	1994-02-09
K930278	Storz Compuscan Ab	Storz	IYO	Class II	1994-02-09
K930124	Variant of Octostop and Octopaque	Octostop, Inc.	KXH	Class I	1994-02-09
K930043	Acu-Evac	Acuderm, Inc.	FYD	Class II	1994-02-09
K924272	Mediresp III	Medflow Corp., Inc.	BTL	Class II	1994-02-09
K923730	Model 561 C-Arm Procedures Stretcher	Midmark Corp	FPO	Class II	1994-02-09
K922818	Snore-No-More	Great Lakes Orthodontics, Ltd.	LQZ	Class II	1994-02-09
K920955	Apr(r) Hip Syst & Natural-Hip(r) for Uncement Use	Intermedics Orthopedics	LPH	Class II	1994-02-09
K920218	Esophageal Z-Stent	Wilson-Cook Medical Inc.	ESW	Class II	1994-02-09
K920039	Mediject Disposable Syringes	P.T. Igar Jaya	FMF	Class II	1994-02-09
K931767	Astra Tech Implants-Dental System	Astra Tech, Inc.	DZE	Class II	1994-02-08
K935622	Custom Plastic Packs	Associated Medical	FRG	Class II	1994-02-07
K935441	Infinitech Breath Ez	Infinitech, Inc.	BWN	Class I	1994-02-07
K935212	Il Test Heparin (Xa), Pn 84699-15	Instrumentation Laboratory Co.	KFF	Class II	1994-02-07
K935168	Zefon Pediatric Anesthesia Breathing Circuit Kits	Bill Olson Corp.	CAI	Class I	1994-02-07
K934971	Sterile Laparotomy Sponges	Medsurg Industries, Inc.	GDY	Class I	1994-02-07
K934918	Epm-3300 Video Processor	Pentax Precision Instrument Corp.	FET	Class II	1994-02-07
K934805	Hearit	Je Liss & Co., Inc.	LZI	Class II	1994-02-07
K934377	Innerdyne Remote Radially Expanding Dilator Remote R.e.d.	Interventional Thermodynamics, Inc.	FGE	Class II	1994-02-07
K934204	Intertip Infusion Set	Oasis Medical, Inc.	HQE	Class II	1994-02-07
K934097	I Sight 2020 Endoscopic & Surgical Video Camera	Sharplan Lasers, Inc.	GCJ	Class II	1994-02-07
K933939	Bact/alert Blood Collection Adapter Cap and Insert	bioMerieux, Inc.	GIM	Class II	1994-02-07
K933586	Minimax Plus Hollow Fiber Oxygenator (with or without Medtronic/carmeda Bioactive Surface	Medtronic, Inc.	DTZ	Class II	1994-02-07
K933472	Shimadzu Digital Substraction Syst Dar-2400 Series	Shimadzu Corp.	JAA	Class II	1994-02-07
K932671	Therex R-Port	Therex Corp.	LJT	Class II	1994-02-07
K932434	Proximate Articulating Linear Stapler	Ethicon Endo-Surgery Inc	OCW	Class II	1994-02-07
K931935	Endpoint 500 Peracetic Acid Test Indicators	Medivators Inc	JOJ	Class II	1994-02-07
K931872	The Eagle 3017 100% Ethylene Oxide Sterilizer	American Sterilizer Co.	FLF	Class II	1994-02-07
K931820	Carapace Stillwater Bowl Set	Carapace, Inc.	LRO	Class II	1994-02-07
K931716	Battery Pack 1017La	Portable Power Systems, Inc.	DSI	Class II	1994-02-07
K931669	Carapace Debridement Kits	Carapace, Inc.	FRG	Class II	1994-02-07
K931561	Trocar Sleeve	L.A.S.E.R., Inc.	HET	Class II	1994-02-07
K931187	Implex Acetabular Cup Screw System	Implex Corp.	HWC	Class II	1994-02-07
K930630	Right Atrial Catheter	Akcess Medical Products, Inc.	LJS	Class II	1994-02-07
K930524	End Tidal CO2 Option B	Medical Data Electronics	CCK	Class II	1994-02-07
K940030	Bisco Composite	Bisco, Inc.	EMA	Class II	1994-02-04
K936154	Laparoscopic Trocar Starter Scalpel	BD Becton Dickinson Vacutainer Systems Preanalytic	GCJ	Class II	1994-02-04
K936070	Trend Set 2 Plus	Confi-Dental Products Co.	ELW	Class II	1994-02-04
K936029	Non-Corning (Huber) Needle	Therex Corp.	FMI	Class II	1994-02-04
K935999	Davinci Reconfigurable Laparoscopic Surgical Instruments	Da Vinci Medical, Inc.	GCJ	Class II	1994-02-04
K935977	Sarns Air Detection System	3M Health Care, Sarns	KRL	Class II	1994-02-04
K935917	Challenge Powder-Free, Hypoallergenic, Synthetic Surgical Gloves	BD Becton Dickinson Vacutainer Systems Preanalytic	KGB	Class I	1994-02-04
K935783	Mitraflex Cavity Wound Dressing	Polymedica Industries, Inc.	KMF	Class I	1994-02-04
K935725	Episeal Adhesive Wound Closure Strips	DeRoyal Industries, Inc.	KGX	Class I	1994-02-04
K935628	Sharpsafe Cat. No. 4127	Smiths Industries Medical Systems, Inc.	FMI	Class II	1994-02-04
K935155	Mershon Band Pusher	Dentauraum, Inc.	ECS	Class I	1994-02-04
K935144	Dentaurum Olympia Latex-Elastics and Dentaurum Latex-Elastics	Dentauraum, Inc.	ECI	Class I	1994-02-04
K935140	Dentaurum Steel Ligature Wires	Dentauraum, Inc.	DZC	Class I	1994-02-04
K935139	Fascination Ceramic Bracket	Dentauraum, Inc.	EJF	Class I	1994-02-04