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 2233 of 3531

510(k) clearances, page 2233 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K934949	Digora	Orion Corporation Soredex	IXK	Class II	1994-02-10
K934561	One Time Vial Access Spike	Abbott Medical	FMF	Class II	1994-02-10
K934338	Innovasive Non-Sterile Laparoscopy Instruments Modification	Innovasive Devices, Inc.	GCJ	Class II	1994-02-10
K933564	Skytron Exam Light	Skytron, LLC	KZF	Class I	1994-02-10
K933511	Upgraded Spirometer St-90	Futuremed Div. of Future Impex Corp.	BTY	Class II	1994-02-10
K933401	The Buck	Medical Implements, Inc.	JKA	Class II	1994-02-10
K933268	Candela Guidewire	Candela Corporation	NWU	Class II	1994-02-10
K933090	Ez-Spacer	Airpharma, LLC	CAF	Class II	1994-02-10
K932936	L.a.p. II Spriometry System	Allied Medical LLC	BZG	Class II	1994-02-10
K931258	Softtouch II Lancet Device	Boehringer Mannheim Corp.	FMK	Class II	1994-02-10
K930980	Instrument Makar Perfix Interference Bone Screw	Instrument Makar, Inc.	HWC	Class II	1994-02-10
K930681	3M Prevention Fabric Surgical Gown #78Xx	3M Company	FYA	Class II	1994-02-10
K930476	Guiding Catheter	Boston Scientific Corporation	DQY	Class II	1994-02-10
K930316	Lung Retractors: Davidson, Semb	Thomasville Medical Assoc.	GAD	Class I	1994-02-10
K930032	Retractor Rods	Thomasville Medical Assoc.	KNA	Class II	1994-02-10
K926205	Monosteryl	Utensili Super Abrasivi	EJL	Class I	1994-02-10
K925776	Branemark System Interlocking Abutment/gold Cylind	Nobelpharma USA, Inc.	DZE	Class II	1994-02-10
K925283	Valvulotome	Intramed Laboratories, Inc.	MGZ	Class II	1994-02-10
K924549	Tri-Med Quick-Step(tm) Rectal Tube	Tri-Med Specialties, Inc.	GBT	Class II	1994-02-10
K922732	Interpore Cylindrical Hex Implant, 3.3 Mm Diameter	Interpore Intl.	DZE	Class II	1994-02-10
K920108	Barrier Extra Protection Plus Face Mask	Johnson & Johnson MEDICAL GmbH	FXX	Class II	1994-02-10
K940127	Centermark Securing Wings	Menlo Care, Inc.	KMK	Class I	1994-02-09
K935878	Glasser Suture Needle	Advanced Surgical, Inc.	GCJ	Class II	1994-02-09
K935739	Shave Prep Tray	Cush Medical Products	KCT	Class II	1994-02-09
K935649	Whis-Rad Tubstand Structure/mobile Patient Trolley	Bennett X-Ray Corp.	KPR	Class II	1994-02-09
K935483	E-Z Prep(r) Tray with Hibiclens(r)	BD Becton Dickinson Vacutainer Systems Preanalytic	LRO	Class II	1994-02-09
K935348	Odyssey Clinical Audiometer	Qualitone	EWO	Class II	1994-02-09
K935103	Visionlink Acr-Nema Conversion Utilities	Evergreen Technologies, Inc.	LMD	Class I	1994-02-09
K935084	Increased Sar Package for Mrt-150A	Toshiba America Mri, Inc.	LNH	Class II	1994-02-09
K935048	Artisan Programmer & Hearing Aid	Telex Communications, Inc.	LRB	Class I	1994-02-09
K935010	Wallach Ultra Freeze	CooperSurgical, Inc.	GEH	Class II	1994-02-09
K934647	Karl Storz Cutting Loop Electrodes Modification	Karl Storz Endoscopy-America, Inc.	FJL	Class II	1994-02-09
K934639	Jobst Athrombic Pump - System 2500	Jobst Institute, Inc.	JOW	Class II	1994-02-09
K934593	Bact/alert 120	bioMerieux, Inc.	MDB	Class I	1994-02-09
K934277	Sunglasses	Rainbow Optics, Inc.	HQY	Class I	1994-02-09
K934215	Contain-or	Dlp, Inc.	KKX	Class II	1994-02-09
K934090	S.s.c. Medical Model 5000 Series Bed	Super Sagless Corp.	FNL	Class II	1994-02-09
K933727	Powermatic Examination Table	Hausmann Industries, Inc.	INQ	Class I	1994-02-09
K933687	R & D Batteries,inc. Part Numbers 5164, 5272, 5260	R & D Batteries, Inc.	FKX	Class II	1994-02-09
K933404	Critikon Central Statin Monitor	Critikon Company, LLC	DPS	Class II	1994-02-09
K933390	Remote Reservoir Adapter(tm) Cassette with Bag	Pharmacia Deltec, Inc.	FPA	Class II	1994-02-09
K933294	Mis Clean-Set Flushing Unit and Accessories	Aesculap Inc	FPB	Class II	1994-02-09
K933122	Microbiological Culture Media,martin Lewis Agar	Bioclinical Systems, Inc.	JTY	Class II	1994-02-09
K933016	Candela Pltl-1 Laser System	Candela Corporation	GEX	Class II	1994-02-09
K932552	Sports Medicine Quadrature Shoulder Coil	Magnetic Research, Inc.	LNH	Class II	1994-02-09
K932457	Spyrogel Wound Dressing	Polymint Industrial Co., Ltd.	KGX	Class I	1994-02-09
K932447	Therex Low-Profile Port .6Mm I.d 2.3Mm O.d.	Therex Corp.	LJT	Class II	1994-02-09
K932336	Nu-Gel Island Wound Dressing	Johnson & Johnson MEDICAL GmbH	NAE	Class I	1994-02-09
K931546	End-Irrigating Endoilluminator	Infinitech, Inc.	FST	Class II	1994-02-09
K931293	Ssh-140A Fetal Doppler System	Toshiba America Medical Systems, In.C	IYN	Class II	1994-02-09