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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3392 of 3526

510(k) clearances, page 3392 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K791769	Medtronic Model 6957	Medtronic, Inc.	DTB	Class III	1979-09-19
K791736	Merocel Instrument Wipe	Xomed, Inc.	GEC	Class I	1979-09-19
K791732	Implantable Endocardial Screw-in Elec	Oscor Inc.	DTB	Class III	1979-09-19
K791713	Vickers Medical Model 130 Neavent-Neo	Vickers America Medical Corp.	CBK	Class II	1979-09-19
K791712	Angiotensin Converting Enzyme Assay Sys	Ventrex Laboratories, Inc.	KQN	Class II	1979-09-19
K791665	Scotts Surgical Retractor and Elastic	Lone Star Medical Products	GAD	Class I	1979-09-19
K791644	Royco Model 371 Super Dilutor	Royco Instruments	GKH	Class I	1979-09-19
K791585	Model G-61 Ultrasonic Dental Unit	Cavitron Corp.	ELC	Class II	1979-09-19
K791568	Implantable Pulse Generator Pacemakers	Intermedics, Inc.	DXY	Class III	1979-09-19
K791561	Respirator Disconnect Alarm Va-100	Intersect Medical Products, Inc.	CAP	Class II	1979-09-19
K791530	Ohio Modular Anesthesia Gas Machine	Ohio Medical Products	BSZ	Class II	1979-09-19
K791527	Respirator Disconnect Alarm Cr201	Intersect Medical Products, Inc.	CAP	Class II	1979-09-19
K791506	Model 344	Telex Communications, Inc.	ESD	Class I	1979-09-19
K791442	Bard Biomedical Nerve Locator	C.R. Bard Inc	BXN	Class II	1979-09-19
K791437	Linde Oxygen Concentrator Loc-II	Union Carbide Corp.	CAW	Class II	1979-09-19
K791410	Amalgamator Model Sdc--	Sierra Laboratories, Inc.	EFD	Class I	1979-09-19
K791380	Va 1000	Vitatron Medical BV	DTA	Class II	1979-09-19
K791311	Dahlberg Hearing Aid Model Un	Dahlberg Electronics, Inc.	ESD	Class I	1979-09-19
K790143	Ventricular Lead, Model 6959	Medtronic, Inc.	DTB	Class III	1979-09-19
K791717	Bard Urodynamic Catheters	C.R. Bard Inc	KOD	Class II	1979-09-17
K791694	Calibrator II	Hi Chem, Inc.	JIX	Class II	1979-09-17
K791693	Calibrator I	Hi Chem, Inc.	JIX	Class II	1979-09-17
K791692	Sodium/potassium Buffer Solution	Hi Chem, Inc.	CEM	Class II	1979-09-17
K791691	Sodium/potassium Conditioning Solution	Hi Chem, Inc.	JGS	Class II	1979-09-17
K791690	Cholorde Reagent	Hi Chem, Inc.	JFS	Class II	1979-09-17
K791689	Picric Solution	Hi Chem, Inc.	CGX	Class II	1979-09-17
K791688	Alkaline Buffer	Hi Chem, Inc.	CGX	Class II	1979-09-17
K791687	CO2 Reference Reagent	Hi Chem, Inc.	JFL	Class II	1979-09-17
K791686	CO2 Cup Reagent	Hi Chem, Inc.	JFL	Class II	1979-09-17
K791685	Glucose Reagent	Hi Chem, Inc.	CGA	Class II	1979-09-17
K791683	Sterile Water for Respiratory Therapy	Abbott Medical	BTT	Class II	1979-09-17
K791657	Ldh Isoenzyme Reagent	Electrophoresis Corp. of America	CFE	Class II	1979-09-17
K791656	Enzyme Stabilizing Reagent (Esr)	Electrophoresis Corp. of America	CFE	Class II	1979-09-17
K791655	Cpk Isoenzyme Reagent	Electrophoresis Corp. of America	JHY	Class II	1979-09-17
K791654	Normal Control	Electrophoresis Corp. of America	JJY	Class I	1979-09-17
K791650	Human, C-Reactive Protein (Crp)	Beckman Instruments, Inc.	DCK	Class II	1979-09-17
K791648	Model 54 Flowmeter Back-Pressure Tube	Harris Calorific	CAX	Class I	1979-09-17
K791634	Ao Stylet Laryngoscope, Model Sls-1	American Optical Corp.	CAL	Class I	1979-09-17
K791633	Uc-2000 Uterine Catherization System	Life Support, Inc.	HFO	Class II	1979-09-17
K791606	Gelman Lipoprotein Frs Set. P/n 51213	Gelman Sciences, Inc.	JHO	Class I	1979-09-17
K791597	Wako Triglyceride	Wako Pure Chemical Industries, Ltd.	CDT	Class I	1979-09-17
K791595	Baird-Parker Agar	Isle Media and Sterile Products, Inc.	JSJ	Class I	1979-09-17
K791594	Cystine Tryptic Agar	Isle Media and Sterile Products, Inc.	JSH	Class I	1979-09-17
K791593	Brilliant Green Agar	Isle Media and Sterile Products, Inc.	JSJ	Class I	1979-09-17
K791592	Brilliant Green Bile 2%	Isle Media and Sterile Products, Inc.	JSJ	Class I	1979-09-17
K791591	Motility Test Medium	Isle Media and Sterile Products, Inc.	JSH	Class I	1979-09-17
K791590	Phenylalanine Agar	Isle Media and Sterile Products, Inc.	JSH	Class I	1979-09-17
K791589	G N Broth Hajna	Isle Media and Sterile Products, Inc.	JSD	Class I	1979-09-17
K791587	Elvi 810 Clotscanner	Volu Sol Medical Industries	KQG	Class II	1979-09-17
K791586	Elvi 818 Digiclot Multiscan	Volu Sol Medical Industries	JPA	Class II	1979-09-17