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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2579 of 3530

510(k) clearances, page 2579 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K895120	Bateman Upf II Hip Prosthesis System	3M Company	KWY	Class II	1990-01-11
K894982	Ace Wire Tension Clamp	Buckman Co., Inc.	JEC	Class II	1990-01-11
K894752	PVC Examination Gloves	Dan Dong Linsen Plastic Industrial Co., Ltd.	LYZ	Class I	1990-01-11
K894011	Total Galactose	Alpkem Corp.	KQP	Class II	1990-01-11
K893991	Hemodialysis Concentrates and Related Products	P & A Co.	KPO	Class II	1990-01-11
K892180	Patient Examination Gloves (Vinyl)	Singfar Ent. Co., Ltd.	LYZ	Class I	1990-01-11
K892078	Sensi Touch Patient Exam Gloves (Vinyl)	Taiwan Old Shop Corp.	LYZ	Class I	1990-01-11
K891277	Patient Examination Gloves (Latex)	Grace River Ent., Inc.	LYY	Class I	1990-01-11
K897145	3M Multi-Allergen Ige Fastscreen S7, (G3,4,5,6,8)	3M Company	DHB	Class II	1990-01-10
K896944	Cn Care Sterile Latex Examination Gloves	C.N. Technocrats	LYY	Class I	1990-01-10
K896902	Enzymun Test R Ige	Boehringer Mannheim Corp.	DHB	Class II	1990-01-10
K896339	Modified Labeling on Okamoto Harmony Condom	Okamoto U.S.A., Inc.	HIS	Class II	1990-01-10
K896247	Clp Comprehensive Lipid Control-Hr	Creative Laboratory Products, Inc.	JJY	Class I	1990-01-10
K896246	Clp Comprehensive Lipid Control-Lr	Creative Laboratory Products, Inc.	JJY	Class I	1990-01-10
K896132	Enamel Prep Enamel Etchant (Email-Preparator Gs)	Ivoclar North America, Inc.	EBF	Class II	1990-01-10
K896056	Rexton Rx12d Custom in-the-Ear Hearing Aid	Rexton, Inc.	ESD	Class I	1990-01-10
K896043	Mattress Cover for Medical Purposes	Keystone Veterinary Supplies, Inc.	KME	Class I	1990-01-10
K896042	Medical Disposable Bedding	Keystone Veterinary Supplies, Inc.	IQK	Class I	1990-01-10
K895985	Sani-Piks Dental Hand Instrument	Bison-Lee Co.	EKJ	Class I	1990-01-10
K895477	Nova Pillow	Nova Health Systems, Inc.	IQK	Class I	1990-01-10
K895282	Charise Charles Reagent Strips	Lee Import Domestic Consulting	JIL	Class II	1990-01-10
K895237	Latex Patient Examination Gloves	China Shanghai SI da Latex & Plastics Co., Ltd.	LYY	Class I	1990-01-10
K895228	Patient Examination Gloves	Ray Intl. Co.	LYY	Class I	1990-01-10
K894477	Insure Match Mate Porcelain Veneer Try-in System	Cosmedent, Inc.	EMA	Class II	1990-01-10
K894437	Peel-Vue Autoclave/chemicalve Pouch	Clive Craig Co.	FRG	Class II	1990-01-10
K894376	Latex Examination Gloves	P.T. Haluwiko Pratita	LYY	Class I	1990-01-10
K894092	Dental Endodontic Cement (Modification)	The Hygenic Company, LLC	KIF	Class II	1990-01-10
K893217	Latex Prophylactic/rubber Contraceptive	Shinhen Corp.	HIS	Class II	1990-01-10
K892702	Patient Examination Gloves (Latex)	P.T. Daifatex Indah	LYY	Class I	1990-01-10
K892562	Patient Examination Gloves (Latex)	Yiu Tsun Industrial Co., Ltd.	LYY	Class I	1990-01-10
K892287	Patient Examination Gloves (Latex)	Supermax Sdn Bhd	LYY	Class I	1990-01-10
K896724	Cryojet Liquid Nitrogen Spray Cryosurgical Instru.	Stiefel Research Institute, Inc.	GEH	Class II	1990-01-09
K896711	Listing Podiatry as Intended Use for Endoguide	Luxar Corp.	GEX	Class II	1990-01-09
K896619	List Dermatology/plastic Surgery as Use Endoguide	Luxar Corp.	GEX	Class II	1990-01-09
K896618	List General Surgery as Intended Use for Endoguide	Luxar Corp.	GEX	Class II	1990-01-09
K896617	Listing ENT as Intended Use for Endoguide	Luxar Corp.	GEX	Class II	1990-01-09
K896614	S.a.f. Acetabular Cup with Porous Coating	Synergy Orthopaedics Intl., Inc.	JDL	Class III	1990-01-09
K896595	Luxar Endoguide CO2 Laser Waveguide	Luxar Corp.	GEX	Class II	1990-01-09
K896586	Rate Increase for Ippb/ipv	Percussionaire Corp.	DZD	Class I	1990-01-09
K896439	Tubing Flexible Medical Gas Low-Pressure	Salter Labs	BZO	Class I	1990-01-09
K896181	Apt Trachea Tubes	Advanced Pulmonary Technologies, Inc.	BTR	Class II	1990-01-09
K896152	Puritan-Bennett Oxygen Pressure Regulator W/flow.	Medtronic, Inc.	CAN	Class I	1990-01-09
K896136	Infant c.p.a.p. Monitor	Hudson Oxygen Therapy Sales Co.	CAP	Class II	1990-01-09
K896128	Puritan-Bennett Oxygen Pressure Regulator	Medtronic, Inc.	CAN	Class I	1990-01-09
K896121	Schiller Model Sp-200 Spirovit(tm)	Schiller America, Inc.	BZG	Class II	1990-01-09
K896120	Schiller Model Sp-100 Spirovit(tm)	Schiller America, Inc.	BZG	Class II	1990-01-09
K896108	The Pilot Scimed Torque Device	Scimed Life Systems, Inc.	LOX	Class II	1990-01-09
K895977	Acusource 600 (TENS)	Microcurrent Research, Inc.	GZJ	Class II	1990-01-09
K895962	Kirschner Performance Total Knee System, Porous	Kirschner Medical Corp.	JWH	Class II	1990-01-09
K895946	Bivona Carden Intermittent Jetting Device	Bivona Medical Technologies	BTL	Class II	1990-01-09