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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3246 of 3528

510(k) clearances, page 3246 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K820265	Ana Test (Mouse Liver Substrate)	Meloy Laboratories, Inc.	DHN	Class II	1982-02-12
K820241	Wako Calcium C Test	FUJIFILM Healthcare Americas Corporation	CIC	Class II	1982-02-12
K820235	Tptz Chloride	American Monitor Corp.	CHJ	Class II	1982-02-12
K820233	Ultrazyme Plus Gamma Gt(65055-65056)	Harleco	JQB	Class I	1982-02-12
K820229	Norton Flow Directed Thermodilution Cath	Norton Performance Plastics Corp.	DYG	Class II	1982-02-12
K820222	Swan-Ganz Vip-Catheter	American Edwards Laboratories	DYG	Class II	1982-02-12
K820217	Lkb-Wallace 1251 Luminometer	Lkb Instruments, Inc.	JJQ	Class I	1982-02-12
K820213	Saline Solution	Dms Laboratories	JTO	Class I	1982-02-12
K820212	Oxi	Dms Laboratories	JTO	Class I	1982-02-12
K820211	Ninhydrin	Dms Laboratories	JTO	Class I	1982-02-12
K820210	Ind	Dms Laboratories	JTO	Class I	1982-02-12
K820209	Zyme B	Dms Laboratories	JTO	Class I	1982-02-12
K820202	Continuous Flush Device/fdi	Linton Biomed Corp.	DRS	Class II	1982-02-12
K820201	Dispos. Monitoring Sys/li Et Al	Linton Biomed Corp.	DRS	Class II	1982-02-12
K820196	Electrosurgical Disp. Dispersive Pad	Promedicon, Inc.	KNS	Class II	1982-02-12
K820191	Control Set	Syva Co.	DIF	Class I	1982-02-12
K820190	Calibrator Set	Syva Co.	DKB	Class II	1982-02-12
K820189	Carbamazepine Assay	Syva Co.	KLT	Class II	1982-02-12
K820187	Syva Advance Sys. Emit,(r)-Aed(r) Pheny	Syva Co.	LES	Class II	1982-02-12
K820186	Bard Cardiopulmonary Monitoring Lines	C.R. Bard Inc	DRS	Class II	1982-02-12
K820155	Specialist Cast Padding	Stan-Pak Ent.	ITG	Class I	1982-02-12
K820140	Webril Cast Padding	Stan-Pak Ent.	ITG	Class I	1982-02-12
K820121	Laserpor Ap Atrial Endocard. Electr. Ld.	Telectronics, Inc.	DTB	Class III	1982-02-12
K820114	System V.heart Rate/respir. Rate Monit.	Narco Air-Shields	DRT	Class II	1982-02-12
K820110	Biox III	Biox Technology, Inc.	DQA	Class II	1982-02-12
K820108	Topper Sponges	Stan-Pak Ent.	NAB	Class I	1982-02-12
K820107	Guaze Sponges, Plain	Stan-Pak Ent.	EFQ	Unclassified	1982-02-12
K820106	X-Ray Guaze Sponges	Stan-Pak Ent.	EFQ	Unclassified	1982-02-12
K820076	Glyco-Sep Reagent Test Set	Clin Tech Diagnostics Corp.	LCP	Class II	1982-02-12
K820067	Electroencephalograph ECG-6151	Nihon Kohden America Inc	DPS	Class II	1982-02-12
K813621	Curity Bedside Drainage Bag	The Kendal Co.	KNX	Class II	1982-02-12
K813463	Sil-V-Ur Chest Catheter	C.R. Bard Inc	GBS	Class I	1982-02-12
K813457	Fetascan 2000,2000A Obstetrical Data	Cranbury Medical Labs, Inc.	HGM	Class II	1982-02-12
K813350	Novametrix Model 807 Transcut. Monitor	Novametrix Medical Systems, Inc.	KLK	Class II	1982-02-12
K813246	Medical Multilith Pulse Genera-1140	Ela Medical, Inc.	DXY	Class III	1982-02-12
K813170	Ila(inverted Linear Anastomosis) Stapler	Surgeons Choice, Inc.	GAG	Class II	1982-02-12
K820234	Hollister Female Urinary Collect Sys	Hollister, Inc.	KNX	Class II	1982-02-10
K820219	Open Loop Infusion Pump	Iatric Devices	FRN	Class II	1982-02-10
K820063	Keofeed 500 Enteric Feeding Pump	Hedeco	FRN	Class II	1982-02-10
K820032	Vit-O-Meter	Health Scan, Inc.	BZG	Class II	1982-02-10
K813598	101 Total Condylar Knee System	Intermedics Orthopedics	JWH	Class II	1982-02-10
K813404	Freeze Dried Ficin	Biological Corp. of America	KSK	Class II	1982-02-10
K813356	Device for Repositioning a Bet Patient	Ali-Oop Co., Inc.	FNJ	Class I	1982-02-10
K813325	Key Med Foreign Body Removal Tube	Keymed, Inc.	FED	Class II	1982-02-10
K813283	10D (TENS Device)	Staodynamics, Inc.	GZJ	Class II	1982-02-10
K812485	Dako Pap Kit K504	Dako Corp.	DFH	Class II	1982-02-10
K812484	Dako Pap Kit K505	Dako Corp.	DEW	Class II	1982-02-10
K812421	Sterile Disposable Surgical Gloves	Intermarket Latex, Inc.	KGO	Class I	1982-02-10
K812015	Glaukon	Sonometrics Systems, Inc.			1982-02-08
K820223	Oms Quartz Infusion Contact Lens	Optical Micro Systems, Inc.	HJI	Class I	1982-02-05