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 2199 of 3531

510(k) clearances, page 2199 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K941361	Microsomal Eia Test Kit	Immunoprobe, Inc.	JNL	Class II	1994-05-11
K941358	Thyroglobulin Eia Test Kit	Immunoprobe, Inc.	JNL	Class II	1994-05-11
K941232	Thora-Cath	Gesco Intl., Inc.	JOL	Class II	1994-05-11
K940622	Elias Ena Screen (Microtiter Plate)	Elias U.S.A., Inc.	LLL	Class II	1994-05-11
K940401	Jr. Microcoagulation System	Accriva Diagnostics, Inc.	JPA	Class II	1994-05-11
K940229	Syn Ena Screen (Pin Plate)	Elias U.S.A., Inc.	LLL	Class II	1994-05-11
K935785	Karl Storz Irrigation and Suction System Handpiece and Accessories	Karl Storz Endoscopy-America, Inc.	HET	Class II	1994-05-11
K925467	Jj Skinner Carekits(tm) Dry/wet/gel Skin Scrub Kit	J.J. Skinner, Inc.	LRO	Class II	1994-05-11
K941968	Valley Model E2750-T Pencil Grip Laparoscopic	Medtronic, Inc.	GEI	Class II	1994-05-10
K941263	Comfeel Plus Wound Dressing	Richard Hamer Assoc., Inc.	KMF	Class I	1994-05-10
K941105	Uorcap,model Number Uds-Ucap	Laborie Medical Tech Corp.	EXY	Class II	1994-05-10
K941094	Insufflation Tubing & Filter	H & C Chemical, Inc.	HET	Class II	1994-05-10
K940918	I-Stat 200 Portable Clinical Analyzer	I-Stat Corp.	CHL	Class II	1994-05-10
K940780	Scopejockey	Fibertech Instruments, Inc.	OCU	Class II	1994-05-10
K940462	Hydromat Trumpet Valve and Tubing Set for Laparoscopic Suction and Irrigation	Karl Storz Endoscopy-America, Inc.	HET	Class II	1994-05-10
K936212	Glucofilm Test Strips	Kulzer GmbH	CGA	Class II	1994-05-10
K935717	Affinity Venous Reservior Bag	Avecor Cardiovascular, Inc.	DTN	Class II	1994-05-10
K935701	Viennatone an, Viennatone as Fidelity F228, Fidelity F229	Starkey Laboratories, Inc.	LXB	Class II	1994-05-10
K935600	Tracheal Suction Catheter	Puritas Health Care, Inc.	BSY	Class I	1994-05-10
K935015	Quadrature Small Extremity Coil	Magnetic Research, Inc.	LNH	Class II	1994-05-10
K934715	Model 222 Clinical Audiometer	Virtual Corp.	EWO	Class II	1994-05-10
K934114	Karl Storz Electronic Laparoflator	Karl Storz Endoscopy-America, Inc.	HIF	Class II	1994-05-10
K934043	Karl Storz Electronic Laparoflator	Karl Storz Endoscopy-America, Inc.	HIF	Class II	1994-05-10
K932902	Magnum	Sps, Inc.	BZQ	Class II	1994-05-10
K931855	Lightwriter	Zygo Corp.	ILQ	Class II	1994-05-10
K931474	Drug, Insurance, Urinalysis, Blood/urine Test Kits	Gbf Medical Group	KDW	Class I	1994-05-10
K921727	Core Monitoring System-Sp1475/6275/5607/5708/4575	Viggo-Spectramed	KNF	Class II	1994-05-10
K921518	Lifetek Iui Catheter	Lifetek Medical, Inc.	MFD	Class II	1994-05-10
K941754	Powder Free Latex Exmination Gloves	Sj Medical Products (M) Sdn Bhd	LYY	Class I	1994-05-09
K941680	Sunglasses	Walmart Stores	HQY	Class I	1994-05-09
K941529	Sunglasses	Wesearch, Inc.	HQY	Class I	1994-05-09
K941442	I Care	I Care Intl., Inc.	HQY	Class I	1994-05-09
K941415	Fitipaldi Driving Sunglasses	L'Equipe Visual, Inc.	HQY	Class I	1994-05-09
K941129	Con-Kit	Medical Chemical Corporation	LKS	Class I	1994-05-09
K940797	Sime Surgical Latex Glove	Sime Health, Ltd.	KGO	Class I	1994-05-09
K940277	Paflufocon a, B, C & D	Paragon Vision Sciences, Inc.	HQD	Class II	1994-05-09
K940008	Glycated Protein Calibrators	Trinity Biotech (Primus Corporation dba Trinity Biotech)	JIS	Class II	1994-05-09
K936202	Urinary Albumin Test Pack	Dupont Medical Products	JIQ	Class I	1994-05-09
K935864	Powdered Examination Gloves (Hypoallergenic)	Wembley Rubber Products (M) Sdn Bhd	LYY	Class I	1994-05-09
K935464	Comfit	Wembley Rubber Products (M) Sdn Bhd	KGO	Class I	1994-05-09
K935063	Instru Klenz	Calgon Corp.	FLG	Class I	1994-05-09
K935014	Active Dehydroepiandrosterone (Dhea)(dsl 9000)	Diagnostic Systems Laboratories, Inc.	JKC	Class I	1994-05-09
K932825	Microarch Gold Bracket	Gac Intl., Inc.	EJF	Class I	1994-05-09
K931114	Select(r) Shoulder All-Poly Glenoid	Intermedics Orthopedics	KWT	Class II	1994-05-09
K926560	Epic (Electrophysiology Imaging Computer	Fischer Imaging Corp.	JAA	Class II	1994-05-09
K926185	Primus Pss Series Sterilizers	PRIMUS Sterilizer Company LLC	FLE	Class II	1994-05-09
K925733	Isoflux Ixl Flow Regulator	Ferguson Medical	FPA	Class II	1994-05-09
K925732	Isoflux Ixz Flow Regulator	Ferguson Medical	FPA	Class II	1994-05-09
K925731	Isoflux Ixp Flow Regulator	Ferguson Medical	FPA	Class II	1994-05-09
K925086	Automatic Needle Disconect (a.n.d.)	Post Medical, Inc.	FMI	Class II	1994-05-09