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 2026-10-19, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 3022 of 3529

510(k) clearances, page 3022 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K843683	Modular Fiberscope System	Reichert Scientific Instruments	GCP	Class II	1985-01-18
K843186	Eska Multistage Esophageal Bougie	Dacomed Corp.	FAT	Class II	1985-01-18
K842759	Model 503Fb	Atrix	LOS		1985-01-18
K842236	Patient Monitor 78354A	Hewlett-Packard Co.	DRT	Class II	1985-01-18
K842145	Transvenous Tined Ventricular Lead	Medtronic, Inc.	DTD	Class II	1985-01-18
K842122	4A	Life Products, Inc.	CBK	Class II	1985-01-18
K842065	Epicardial, Unipolar Lead 4951	Medtronic, Inc.	DTD	Class II	1985-01-18
K842032	Models 4012/4512 Transvenous Tined-	Medtronic, Inc.	DTB	Class III	1985-01-18
K842031	Transvenous Tined Ventricular/atrial	Medtronic, Inc.	DTB	Class III	1985-01-18
K841392	Biomatt-1	Biorec Us, Inc.	BZQ	Class II	1985-01-18
K841190	Microtrak Hsv 1 & 2 Direct Speciman	Syva Co.	GQL	Class II	1985-01-18
K844025	Contour Chair Lounge W/optiional Heat & Massage	Craftmatic/Contour Organization, Inc.	INO	Class II	1985-01-17
K844855	Ventrescreen Strep a Test	Ventrex Laboratories, Inc.	GTZ	Class I	1985-01-16
K844823	Microinfertility Forceps, Titanium	Precision Surgical Instrument, Inc.	KNA	Class II	1985-01-16
K844822	Microinfertility Scissors, Titanium	Precision Surgical Instrument, Inc.	KNA	Class II	1985-01-16
K844821	Microinfertility Needle Holder, Titanium	Precision Surgical Instrument, Inc.	KNA	Class II	1985-01-16
K844756	St Family of Hollow Fiber Dialyzers	Travenol Laboratories, S.A.	FKQ	Class II	1985-01-16
K844625	Bipore o.2 Micron Hydrophobic Filter Assembly	Bipore, Inc.	KOZ	Class I	1985-01-16
K844602	Scented Menstrual Pad	Procter & Gamble Mfg. Co.	HHD	Class I	1985-01-16
K844601	Unscented Menstrual Pad	Procter & Gamble Mfg. Co.	HHD	Class I	1985-01-16
K844582	Syncor Tech Chlamydia Tissue Culture Test	Syncor Intl. Corp.	LJP	Class I	1985-01-16
K844548	Urea Agar	bioMerieux, Inc.	JSH	Class I	1985-01-16
K844547	Tryptic Soy Broth W/6.5%sodium Chloride	bioMerieux, Inc.	JSD	Class I	1985-01-16
K844546	Cystine Tryptic Agar W/sucrose	bioMerieux, Inc.	JSF	Class I	1985-01-16
K844545	Cystine Tryptic Agar W/mannitol	bioMerieux, Inc.	JSF	Class I	1985-01-16
K844544	Cystine Tryptic Agar W/maltose	bioMerieux, Inc.	JSF	Class I	1985-01-16
K844543	Cystine Tryptic Agar W/lactose	bioMerieux, Inc.	JSF	Class I	1985-01-16
K844542	Cystine Tryptic Agar W/dextrose	bioMerieux, Inc.	JSF	Class I	1985-01-16
K844460	Nd. Yag Laser Rectal Pathology	Endo Lase, Inc.	LNK	Class II	1985-01-16
K844459	Nd:yag Laser Urological Surgery	Endo Lase, Inc.	LNK	Class II	1985-01-16
K844155	Standard Urinary Drainage Bag & Leg Bag	Norris W. Whitlock	KNX	Class II	1985-01-16
K844081	Lp4 Ventilator	Life Products, Inc.	CBK	Class II	1985-01-16
K843137	Bp 5000	Tech Vend Marketing	DXN	Class II	1985-01-16
K842597	Respiratory Gas Humidifier	Applinc	BZE	Class II	1985-01-16
K845048	Nephrostomy Drainage Catheter & Stiffener	American Edwards Laboratories	LJE	Unclassified	1985-01-15
K845047	Nephrostomy Guidewire Sheath	American Edwards Laboratories	LJE	Unclassified	1985-01-15
K845018	Davol Ercp Cannula	C.R. Bard Inc	ODD	Class II	1985-01-15
K845017	Davol Retrieval Baskets & Forceps	C.R. Bard Inc	OCZ	Class II	1985-01-15
K845016	Davol Polypectomy Snare	C.R. Bard Inc	FDI	Class II	1985-01-15
K845015	Davol Papillitome	C.R. Bard Inc	KNS	Class II	1985-01-15
K845010	Chesebrough-Pond's Uri-Drain Male Urinary Pouch	Chesebrough-Pond'S U.S.A. Co.	EYQ	Class I	1985-01-15
K844801	Ultra External Catheter	Inmed Corp.	KNX	Class II	1985-01-15
K844769	Rigid Fiberopitc Endoscope	Microvasive	GCM	Class II	1985-01-15
K844609	Perry Suturing Set	Perry, Div.			1985-01-15
K844186	Continent Stoma System & Accessories	Chesebrough-Pond'S U.S.A. Co.	KBG	Class I	1985-01-15
K844143	Olympus Pf-27M Flexible Ureterorenoscope	Olympus Corp.	FGB	Class II	1985-01-15
K842105	Right Ventricular Ejection Fraction-	American Edwards Laboratories	DXG	Class II	1985-01-15
K850042	Solar Tan - Solaria IV	Sola-Tan Intl.	FTC	Class II	1985-01-14
K845028	Martanique 7-Tube Ruva Home Solarium	Bainbridge Trading Co., Ltd.	FTC	Class II	1985-01-14
K844977	Holter Cura-Lite Recorder	Cardionostics, Inc.	DSH	Class II	1985-01-14