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 2190 of 3531

510(k) clearances, page 2190 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K941409	Ena Profile-6 Elisa Test System	Zeus Scientific LLC	LJM	Class II	1994-06-10
K941339	Sterile Wound Hydrogel Dressing	Renaissance Pharmaceutical, Inc.	MGQ	Unclassified	1994-06-10
K941150	Mdt Shampaine 5100B and 5100E Surgical Tables	Mdt Technology for Life	FQO	Class I	1994-06-10
K941106	Model Ti500 Isolette Infant Incubator	Air-Shields, Inc.	FPL	Class II	1994-06-10
K941014	Ena Screen Elisa Test System	Zeus Scientific LLC	LJM	Class II	1994-06-10
K940988	Accessories, Surgical Camera	Woodbine Optical Corp.	GCJ	Class II	1994-06-10
K940804	Smartneedle Vascular Access System, Modification	Peripheral Systems Group	ITX	Class II	1994-06-10
K940700	Autozyme Screen	Cambridge Life Sciences PLC.	LJM	Class II	1994-06-10
K940585	Selisa Anti-N DNA Antibodies	Cambridge Life Sciences PLC.	LRM	Class II	1994-06-10
K940441	Dial Medical Supply Fistula Needle Set	Dial Medical of Florida, Inc.	FOZ	Class II	1994-06-10
K940117	Mid-500	Block Medical, Inc.	MEB	Class II	1994-06-10
K935684	IV Start Kit	Cush Medical Products	LRS	Class II	1994-06-10
K935643	Syrigene Acetic Acid Pre-Filledsyringe	Regulatory & Marketing Services, Inc.	KNY	Class II	1994-06-10
K935436	Alpha-Dent Glass Ionomer Cement, Self Cured	Wallace A. Erickson & Co.	EMA	Class II	1994-06-10
K935292	Schneider Guidezilla Softip Guiding Catheter	Boston Scientific Corporation	DQY	Class II	1994-06-10
K935092	Convenience Contour Kits Redi Nurse System	Contour Fabricators of Florida, Inc.	FMF	Class II	1994-06-10
K933960	Plasma Recovery Program for the Cobe Brat 2 Autologous Blood Salvage System	LivaNova USA, Inc.	CAC	Class II	1994-06-10
K933750	Microsurge Reusable Front End Grasp Devices, Modif	Microsurge, Inc.	GCJ	Class II	1994-06-10
K932477	Unimix Conainer-Empty Container W/3 Lead Trans.set	Baxter Healthcare Corporation	KPE	Class II	1994-06-10
K931875	Autoclavable Reusable Wrap -- Centeral Service Use	Amsco Sterile Recoveries, Inc.	FRG	Class II	1994-06-10
K931874	Recoveries Autoclavable Resuable Wrap -- Fac. Use	Amsco Sterile Recoveries, Inc.	FRG	Class II	1994-06-10
K931145	Non-Sterile Isolation Gown	Amsco Sterile Recoveries, Inc.	FYC	Class II	1994-06-10
K931144	Sterile Surgeon's Gown, Modification	Amsco Sterile Recoveries, Inc.	FYA	Class II	1994-06-10
K926596	Owens Endoscopic Instruments and Accessories	Owens Industries, Inc.	HET	Class II	1994-06-10
K922627	Gore-Tex Regenerative Material	W. L. Gore & Associates, Inc.	NPK	Class II	1994-06-10
K942223	Body System	Conair LLC.	ISA	Class I	1994-06-09
K941594	Wahl Double Comfort Massager	Wahl Clipper Corp	ISA	Class I	1994-06-09
K941484	Daily Wear Soft Contact Lenses	Alcon Laboratories	LPL	Class II	1994-06-09
K941412	Wahl Compact Comfort Massager	Wahl Clipper Corp	IRO	Class I	1994-06-09
K941390	Disposable Aspiration/irrigation Trumpet Valve Probe	DeRoyal Industries, Inc.	GCJ	Class II	1994-06-09
K941385	Pro Pulse Syringe Irrigation System	Giesy Consultants, Inc.	LJH	Class II	1994-06-09
K940837	Wahl(r) Foot Comfort Massager	Wahl Clipper Corp	IRO	Class I	1994-06-09
K940683	Wahl(r) Ultra Comfort Massager Spec #89Isa	Wahl Clipper Corp	ISA	Class I	1994-06-09
K940586	K-Snap	Katecho LLC	DRX	Class II	1994-06-09
K940442	Mpr-814	Xri, Inc.	IYB	Class I	1994-06-09
K935995	Hand-Held Heat Applicator	Avon Products, Inc.	ILY	Class II	1994-06-09
K934886	Next Wave Physioacoustic Mattress	Next Wave, Inc.	IRO	Class I	1994-06-09
K934288	Holde.t. Endotracheal Tube Stabilization Bar	Neo-Tech, Inc.	CBH	Class I	1994-06-09
K934119	Energized Drug Container System	Abbott Medical	FPA	Class II	1994-06-09
K932861	Flexiflo Gastrostomy Kit	Abbott Medical	KNT	Class II	1994-06-09
K931655	P.f.c. Bipolar Hip System	Johnson & Johnson Orthopaedics, Inc.	KWY	Class II	1994-06-09
K931079	Stat-TENS	Skylark Device Co., Ltd.	GZJ	Class II	1994-06-09
K930263	Matrix Pro-Elecdt	Matrix Electromedical, Inc.	LIH	Class II	1994-06-09
K925102	Flexiflo Laparoscopic Jejunostomy Kit	Abbott Medical	KNT	Class II	1994-06-09
K923260	Laparoscopy Sets, Needle Holders, Blunt Curved	Imtec Corp.	HET	Class II	1994-06-09
K922456	K6-I Diagnostic System	Myo-Tronics, Inc.	KZM	Class II	1994-06-09
K942416	Hasson Graspers	Linvatec Corporation	GCJ	Class II	1994-06-08
K942319	Hirsch Bipolar Coagulation Forceps and Adaptor Cables	Berchtold Holding GmbH	GEI	Class II	1994-06-08
K942064	Disposable Nasal Rongeur	United States Surgical, A Division of Tyco Healthc	LRC	Class I	1994-06-08
K942063	Disposable Nasal Scissor	United States Surgical, A Division of Tyco Healthc	LRC	Class I	1994-06-08