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 2209 of 3531

510(k) clearances, page 2209 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K931270	Surgiclean Enzymatic Instrument Cleaner	Surgicot, Inc.	FLG	Class I	1994-04-13
K931042	Moore Secure Cap	Kerma Medical Products, Inc.	LYU	Class I	1994-04-13
K913556	Ivalon Embolization Particles	Ivalon	HCG	Class II	1994-04-13
K941147	Splashmaster Oc Eye and Face Protective Products	Cabot Safety Corp.	HQY	Class I	1994-04-12
K941076	Sunglasses and Sport Sunglasses	20/20 Ent.	HQY	Class I	1994-04-12
K941059	Frontier Novelty Daelim Optical Frame	Frontier Novelty, Inc.	HQZ	Class I	1994-04-12
K941055	Non-Prescription Sunglasses	Kingsun Optical Ent. Co., Ltd.	HQY	Class I	1994-04-12
K941052	Eyeglass Spectacle Frames Various Collections	Atlantic Optical Co., Inc.	HQZ	Class I	1994-04-12
K941051	Spectacle Frames/sunglasses	Europa/Encore Eyewear	HQY	Class I	1994-04-12
K940853	Morrison Frame, Spectacle	Morrison Center	HQZ	Class I	1994-04-12
K940846	Nil	Evergreat Optical Ind Co., Ltd.	HQY	Class I	1994-04-12
K940827	Rewinner ENT H.k. Branch Non-Prescription Sunglasses	Rainbow Merchandise, Inc.	HQY	Class I	1994-04-12
K940782	Artsun Optical Frame	Frontier Novelty, Inc.	HQZ	Class I	1994-04-12
K940777	Bayvue (Polymacon) Soft (Hydrophilic) Contact Lens	Unilens Corp., USA	LPL	Class II	1994-04-12
K940730	Yon's Jay Enterprise Co	Yon'S Jay Enterprise Co.	HQY	Class I	1994-04-12
K940613	E.m.a.	European Manufacturers Agency, Inc.	HQY	Class I	1994-04-12
K940241	Acufex Video System	Acufex Microsurgical, Inc.	GCJ	Class II	1994-04-12
K940219	Trigel- Multifunction Electrode	Physiometrix, Inc.	GEI	Class II	1994-04-12
K940182	Sunglasses	Beta Toys, Inc.	HQY	Class I	1994-04-12
K940077	Spectacle Frames (Wing Shing Optical)	Continental Optical Imports	HQZ	Class I	1994-04-12
K940043	Bioscan Reagent Strips	Bioscan Instruments, Inc.	JIL	Class II	1994-04-12
K935629	Usdt Phencyclidine (Pcp) Assay Column Cat. No. 9000-400	U.S. Drug Testing, Inc.	LCM	Unclassified	1994-04-12
K934196	Codman Quick Shunt Kit, Cat. #82-6570	Cerenovus, Inc.	GWG	Class II	1994-04-12
K933682	Direct Amylase (Ec 3.2.1.1) Method for Technicon Systems	Miles, Inc.	JFJ	Class II	1994-04-12
K932844	Sunglasses	Glascal Industries, Ltd.	HQY	Class I	1994-04-12
K932432	Kronner Reinforcing Stylette	Unimar, Inc.	LKF	Class II	1994-04-12
K932345	Tech-Switch Electrosurgical Pencil, Single Use	Conmedcorp	DWG	Class II	1994-04-12
K931778	Laparoscopy Instruments	Buckman Co., Inc.	GCJ	Class II	1994-04-12
K941246	Rae II Tracheal Tube	Mallinckrodt Medical	BTR	Class II	1994-04-11
K941092	Murdoch Laparoscope Lens Cleaner	Cook Inc.	GCJ	Class II	1994-04-11
K940956	Rio Eyewear, Panama Jack Environment Optics, and Paradise Resort Eyewear	Rio Eyewear Group, Inc.	HQY	Class I	1994-04-11
K940944	Day Sun Industrial Corp	Day Sun Industrial Corp.	HQY	Class I	1994-04-11
K940830	Rewinner ENT Co. Ltd. Non-Prescription Sunglasses	Rainbow Merchandise, Inc.	HQY	Class I	1994-04-11
K940828	Wenzhou Import/export Corp. Non-Prescript Sunglasses	Rainbow Merchandise, Inc.	HQY	Class I	1994-04-11
K940806	Non-Prescription Sunglasses	Top Fashion Optical & Sunglasses	HQY	Class I	1994-04-11
K940726	None-Generic	Jay-Y Enterprises Co., Inc.	HQY	Class I	1994-04-11
K940612	E.m.a.	European Manufacturers Agency, Inc.	HQY	Class I	1994-04-11
K940411	Eyeglass Frames (Plastic)	Value Line Optical Services, Inc.	HQZ	Class I	1994-04-11
K936155	Adair Insufflation and Instrumentation Cannula	Micromedical Devices, Inc.	HIF	Class II	1994-04-11
K935774	Curity Fast-Cath Female Catheter Kit	Kendall Healthcare Products Co. Div.Of Tyco Health	EYT	Class I	1994-04-11
K935583	Suction Set, Trachael	Puritas Health Care, Inc.	BSY	Class I	1994-04-11
K934608	Barrier Fabric 450 Surgical Gown	Johnson & Johnson MEDICAL GmbH	FYA	Class II	1994-04-11
K934445	Ststorz Dp5300 and Dp9502 Sterile Drapes	Storz Instrument Co.	KKX	Class II	1994-04-11
K934407	Sunglass Gallery Inc. Sunglass	Sunglass Gallery, Inc.	HQY	Class I	1994-04-11
K933560	Barrier Plastic Packaging (Modification)	Maxxim Medical	KCT	Class II	1994-04-11
K932731	Barrier* Extra Protection Plus Surgical Gown	Johnson & Johnson MEDICAL GmbH	FYE	Class I	1994-04-11
K932689	Lapro-Loader(tm)	Surgimark, Inc.	HET	Class II	1994-04-11
K930965	Los 3D Vision 100	Laser-Optik-Systeme GmbH & Co. KG	GCJ	Class II	1994-04-11
K925468	Jj Skinner Carekits(tm) Blood Collection Kit	J.J. Skinner, Inc.	GJE	Class II	1994-04-11
K925367	A-Dec 7284 Cuspidor, Cascade	A-dec, Inc.	EBR	Class I	1994-04-11