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 2608 of 3530

510(k) clearances, page 2608 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K892466	Patient Examination Gloves (Latex)	Zir Lih Industrial Co., Ltd.	LYY	Class I	1989-09-18
K892041	Patient Examination Gloves (Latex)	United Gloves Sdn. Bhd.	LYY	Class I	1989-09-18
K891292	Srs-200 Radiosurgery System	Philips North America LLC	IYE	Class II	1989-09-18
K891021	Tri-Lumen Intra Vascular Balloon Catheter	Ideal Medical, Inc.	DXE	Class II	1989-09-18
K890766	Catheter Introducer Sheath	Applied Vascular Devices, Inc.	DYB	Class II	1989-09-18
K895337	Electrosurgical Coagulation Suction Tube	New England Surgical Instrument Corp.	HAM	Class II	1989-09-15
K895331	Electrosurgical Electrode	New England Surgical Instrument Corp.	JOS	Class II	1989-09-15
K895325	Suntanning Bed	Sunbronze	LEJ	Class II	1989-09-15
K895248	Ims5000 Illuminated Loupes	Luxtec Corp.	FSP	Class I	1989-09-15
K895202	1420 Heel-Stick(tm) Neonatal Blood Sampling Kit	Transidyne General Corp.	LRO	Class II	1989-09-15
K895198	Hall Versipower Surgical Instrument System	Zimmer GmbH	HWE	Class I	1989-09-15
K895011	Trident Drape Support	Trident Medical Products, Inc.	KKX	Class II	1989-09-15
K894781	Optiflex	Ormco Corp.	EJF	Class I	1989-09-15
K894762	B100 Disposable Handpiece	Beacon Laboratories, Inc.	HAM	Class II	1989-09-15
K894663	Beamer One	Beacon Laboratories, Inc.	HAM	Class II	1989-09-15
K894529	Fpr Theophylline Kit	Colony Laboratories, Inc.	LGS	Class II	1989-09-15
K894509	Bicarbonate Test Item Number: 65412	Em Diagnostic Systems, Inc.	KHS	Class II	1989-09-15
K894505	Cotolin Drain Sponge and Dressing Sponge	James River Corp.	EFQ	Unclassified	1989-09-15
K894480	Patient Examination Gloves	PT. Intan Hevea Industry	LYY	Class I	1989-09-15
K894358	Lumina Orthodontic Bracket	Ormco Corp.	EJF	Class I	1989-09-15
K894007	Patient Examination Gloves	Pre Lotus Industrial Sdn. Bhd.	LYY	Class I	1989-09-15
K893929	Latex Examination Gloves	Ever Growing Ent. Co., Ltd.	LYY	Class I	1989-09-15
K893919	Antec Airway Sampling Device W/moisture Trap	Baxter Healthcare Corporation	CAI	Class I	1989-09-15
K893762	Plus Total Knee System, (Ppd) Tibial Component	Orthomet, Inc.	JWH	Class II	1989-09-15
K893338	Vinyl Examination Gloves	Taiwan an Lih Ent. Co., Ltd.	LYZ	Class I	1989-09-15
K893275	Latex Examination Gloves	Pt Ika Muda Corpora	LYY	Class I	1989-09-15
K893020	Patient Examination Gloves	Dover Products, Inc.	LYY	Class I	1989-09-15
K892992	Patient Examination Gloves	Cypress Ent.	LYY	Class I	1989-09-15
K892861	Dental Pik	U.S. Dentek Corp.	EKS	Class I	1989-09-15
K892216	Gen-Probe Pace System Urine Screen	Hologic, Inc.	JXA	Class I	1989-09-15
K892095	Patient Examination Gloves (Latex)	Madafair, Ltd.	LYY	Class I	1989-09-15
K892021	Sunny Tex (Patient Examination Gloves)	P.T. Indotama Megah Indah Rubber	LYY	Class I	1989-09-15
K890803	Latex Examination Gloves	A-Tek Medical Supply	LYY	Class I	1989-09-15
K895236	Medx Rehabilitation Machine	Medx Corp.	IKK	Class II	1989-09-14
K894724	Safe-Edge Eyeshield	Trident Medical Products, Inc.	HOY	Class I	1989-09-14
K894720	Universal Eyeshield	Trident Medical Products, Inc.	HOY	Class I	1989-09-14
K894149	Mod. Femoral Com. & Cluster Patter Outer Shell	Howmedica Corp.	JDI	Class II	1989-09-14
K884832	Percussionaire Respirators (Multiple)	Percussionaire Corp.	CBK	Class II	1989-09-14
K895079	Ace Beaded K-Wires Ace Olive Wires	Buckman Co., Inc.	HTY	Class II	1989-09-13
K894975	Immunodot Infectious Mononucleosis Test	General Biometrics, Inc.	KTN	Class II	1989-09-13
K894787	Mel-Pak General Drug Delivery System Kit	New York Blood Center, Inc.	FPA	Class II	1989-09-13
K894761	Tandem-E Fsh Immunoenzymetric Assay Kit	Hybritech, Inc.	CGJ	Class I	1989-09-13
K894738	Model 6888 Lead Tunneler	Cardiac Pacemakers, Inc.	DWS	Class I	1989-09-13
K894679	Electrotrace Disp. Resting EKG Electrodes	Jason Marketing Co.	DRX	Class II	1989-09-13
K894651	Coulter Positive Control Cells	Coulter Corp.	GGL	Class II	1989-09-13
K894585	Rep Tm Spe (Ponceau S) Procedures	Helena Laboratories, Corp.	CEF	Class I	1989-09-13
K894180	Abbott Ast-Activated (Liquid, List#01a54)	Abbott Medical	CIT	Class II	1989-09-13
K894079	Latex Examination Gloves	Target USA, Inc.	LYY	Class I	1989-09-13
K893867	Cardiac Outpur/saturated Venous Oxygen Module	Spacelabs, Inc.	DQA	Class II	1989-09-13
K893719	Medi + Form Exam (Mfg: Glove Seal Sdn Bhd)	World Impex Corp.	LYY	Class I	1989-09-13