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 2621 of 3530

510(k) clearances, page 2621 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K891114	Patient Examination Glove (Latex)	Ambusco Co., Inc.	LYY	Class I	1989-08-09
K891069	Usci Coronary Infusion Catheter	C.R. Bard Inc	DQY	Class II	1989-08-09
K890450	Intermedics Apr(tm) II Femoral Component	Intermedics Orthopedics	JDJ	Class II	1989-08-09
K885179	Intro-Flex Sheath Introducer W/amc Thromboshield	Baxter Healthcare Corporation	DYB	Class II	1989-08-09
K893946	Fd 400 Dental Stool	Oriola OY Finndent	KLC	Class I	1989-08-08
K893602	Glass Mercury Filled Thermometers	Smith & Nephew United, Inc.	FLK	Class II	1989-08-08
K892898	Astro Behind-the-Ear Hearing Aid	Rexton, Inc.	ESD	Class I	1989-08-08
K892354	Odis - Obstetrical Display Info System, Hp M1370a	Hewlett-Packard Co.	HGM	Class II	1989-08-08
K892071	General (Biopsy) Needle Guide Kit, Sterile	Amedic USA	KNW	Class II	1989-08-08
K892069	Extended Covers, Sterile	Amedic USA	FFF	Class I	1989-08-08
K894558	Mini Lightscope Set, Lightscope Jr. Set	Optik	HRX	Class II	1989-08-07
K894557	Lightscope Set	Optik	HRW	Class I	1989-08-07
K894396	Surgilase 25, 40, 45, 55, 60, 80, 100 Laser	Surgilase, Inc.	GEX	Class II	1989-08-07
K894302	Oxygen Therapy Regulator	Modern Engineering Co., Inc.	CAN	Class I	1989-08-07
K894273	Nidek Model Akc-8000	Nidek, Inc.	HQF	Class II	1989-08-07
K894072	The Pudenz in Line Valve	Baxter Healthcare Corporation	JXG	Class II	1989-08-07
K894014	Latex Examination Gloves	Hsin Hung Co., Ltd.	LYY	Class I	1989-08-07
K893949	#157 Exam Light	Medmark, Inc.	KFK	Class I	1989-08-07
K893938	Continuous Epidural Anesthesia Tray	Medsurg Industries, Inc.	CAZ	Class II	1989-08-07
K893866	Hood Pediatric Tracheostomy Tube	Hood Laboratories	BTO	Class II	1989-08-07
K893820	CT Sytec 3000	General Electric Co.	JAK	Class II	1989-08-07
K893219	Matrx Dental Unit	Matrix Medica, Inc.	EIA	Class I	1989-08-07
K892925	Vecsei Expanding Screw	Howmedica Corp.	HWC	Class II	1989-08-07
K892884	Medtronic Model 3530 Percutaneous Extension	Medtronic, Inc.	GZB	Class II	1989-08-07
K891996	Gerber Precious Care Electric Breast Pump	Gerber Products Co.	HGX	Class II	1989-08-07
K891131	Gammamed 12I	Mick Radio-Nuclear Instruments, Inc.	JAQ	Class II	1989-08-07
K890765	Strip, Sterilization Indicator; Steam or E.o. Gas	Spsmedical Supply Corp.	JOJ	Class II	1989-08-07
K890764	Label, Sterilization Indicator; Radiation	Spsmedical Supply Corp.	JOJ	Class II	1989-08-07
K890763	Label, Sterilization Indicator; Dual Steam/e.o.gas	Spsmedical Supply Corp.	JOJ	Class II	1989-08-07
K890761	Strip, Sterilization Indicator; Dry Heat	Spsmedical Supply Corp.	JOJ	Class II	1989-08-07
K890760	Strip, Sterilization Indicator, E.o. Gas	Spsmedical Supply Corp.	JOJ	Class II	1989-08-07
K890759	Strip, Sterilization Indicator; Steam	Spsmedical Supply Corp.	JOJ	Class II	1989-08-07
K890758	Dry Heat Sterilization Indicator Tape	Spsmedical Supply Corp.	JOJ	Class II	1989-08-07
K890757	C-Vapor Sterilization Indicator, Chemical Vapor	Spsmedical Supply Corp.	JOJ	Class II	1989-08-07
K890755	Sealing Tape, Sterilization Indicator; Steam	Spsmedical Supply Corp.	JOJ	Class II	1989-08-07
K890638	Volume Computation Software Package	Elscint, Inc.	JOP	Class II	1989-08-07
K890636	Cardiac Computation Software Package	Elscint, Inc.	JOP	Class II	1989-08-07
K890438	Gas-Vak(r), Model 300	Gas-Vak	CBN	Class II	1989-08-07
K890359	Resubmitted Stc Series 8600 Autoclave	Sterilizer Technologies Corp.	FLE	Class II	1989-08-07
K885350	Preemicare Series 2000 Infant Warmer	Preemicare Corp.	FMT	Class II	1989-08-07
K894538	Qm300 Alpha1-Acid Glycoprotein Antibody Pack	Kallestad Diag, A Div. of Erbamont, Inc.	DBN	Class I	1989-08-04
K894336	Surgical Dynamics Discography System	Surgical Dynamics Ltd			1989-08-04
K894031	Pharmaseal Genetic Amniocentesis Tray	Baxter Healthcare Corporation	HIO	Class I	1989-08-04
K893927	Resound Custom in-the Canal Hearing Aid Phs-3	Resound Corp.	ESD	Class I	1989-08-04
K893725	Playtex Tampons, Non-Deodorant/deodorant	Playtex Family Products, Inc.	HEB	Class II	1989-08-04
K893508	Prostate Specific Antigen Immunohistochemical Anti	Baxter Healthcare Corporation	JFH	Class II	1989-08-04
K893432	Personal Amplifier Rechargeable Model Triumph II	Electone, Inc.	ESD	Class I	1989-08-04
K893213	Easy Breather Model 100	Progressive Productions, Ltd.	BYT	Class II	1989-08-04
K893043	Puritan-Bennett 7200Spi Microprocessor Ventilator	Medtronic, Inc.	CBK	Class II	1989-08-04
K892772	Non-Sterile Patient Examination Gloves	Care-Pro Industries, Inc.	LYY	Class I	1989-08-04