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 2026-10-05, 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 3526 of 3526

510(k) clearances, page 3526 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K760018	Vacuum Tubes, Sterile (J-Vac)	Jelco Laboratories	GIM	Class II	1976-07-20
K760017	Consious Sedation (Analor P-76)	Mckesson Corp.	BZR	Class II	1976-07-20
K760013	Pacer Systems Analyzer (Cordis)	Cordis US Corp.	DTC	Class II	1976-07-20
K760009	Colorimetric Determination (Ldh)	The Dow Chemical Co.	CFH	Class II	1976-07-20
K760006	Radioassay, Concept 4	Micromedic Systems			1976-07-20
K760203	Tube, Sterile Non-Conductive Connecting	Ipco Corp.	GCD	Class I	1976-07-19
K760202	Tube, Sterile Conductive Connecting	Ipco Corp.	GAZ	Class II	1976-07-19
K760198	Kit, Platelet Aggregation Reagent (#390)	Chrono-Log Corp.	GHR	Class II	1976-07-19
K760197	Accuvette II	Coulter Electronics, Inc.	JRI	Class I	1976-07-19
K760192	Computer, Thermodilution Cardiac (9520)	Edwards Laboratories	DXG	Class II	1976-07-19
K760171	Fiberbronchoscope (Pentax Fb-17A)	Pilling Co.	EOQ	Class II	1976-07-19
K760170	Intrauterine Sound, Plastic Disposable	G.D. Searle and Co.	HHM	Class I	1976-07-19
K760160	Monitor, Patient (Model 78333A)	Hewlett-Packard Co.	DRT	Class II	1976-07-19
K760157	Sphygmomanometer	Eyvirco	DXQ	Class II	1976-07-19
K760152	Filter (7220&7221 Mobin-Uddin Vena Cava)	Edwards Laboratories	DTK	Class II	1976-07-19
K760150	Monitor, Patient (Model 78331A)	Hewlett-Packard Co.	DPS	Class II	1976-07-19
K760149	Conductive Anesthsia Breath. Circuit	Omnicon Medical Corp.	CAI	Class I	1976-07-19
K760145	Serum, Igg Goat Anti-Human Acid	Oxford Laboratories, Inc.	DEW	Class II	1976-07-19
K760142	Bandage, Rapido-Lastic Cotton/nylon	Conco Medical Co.	FQM	Class I	1976-07-19
K760141	Bandage, Confo-Lastic All Cotton Elastic	Conco Medical Co.	FQM	Class I	1976-07-19
K760140	Bandage, Wrinky-Lastic Elastic Gauze	Conco Medical Co.	FQM	Class I	1976-07-19
K760139	Bandage, E-Cotton Elastic	Conco Medical Co.	FQM	Class I	1976-07-19
K760138	Bandage, Ceb Cotton Elastic	Conco Medical Co.	FQM	Class I	1976-07-19
K760125	Airway, Argyle Nasopharyngeal	Sherwood Medical Industries	BTQ	Class I	1976-07-19
K760137	Tube, Feeding, Argyle	Sherwood Medical Industries	FPD	Class II	1976-07-16
K760122	Will-Ceram Y-2	Williams Gold Refining Co., Inc.	EJT	Class II	1976-07-16
K760121	Impulse Heat Sealer	Lorvic Corp.			1976-07-16
K760112	Spectrophotometer (Junior III)	Revvity Health Sciences, Inc.	JJQ	Class I	1976-07-16
K760111	Filter, i.v., with Flash Bulb (#4701)	Jelco Laboratories	FPA	Class II	1976-07-16
K760110	Filter, i.v. (#4700)	Jelco Laboratories	FPA	Class II	1976-07-16
K760103	Cap, Injection (#4600)	Jelco Laboratories	FPA	Class II	1976-07-16
K760102	Flowmeter, P.c., Redesigned Version	Ohio Medical Products	CAX	Class I	1976-07-16
K760094	Sponge, Curity Washed Gauze	Kendall Research Center	NAB	Class I	1976-07-16
K760086	Tray, Blood Sampling (Pulsator II)	Concord Laboratories, Inc.	GJE	Class II	1976-07-16
K760082	Bottle, Condensate (#1628)	Inspiron Corp.	CBC	Class II	1976-07-16
K760077	Test, Ria, Serum Digoxin	Smithkline Diagnostics, Inc.	DND	Class II	1976-07-16
K760076	Absorber, Anesthesia Circle Sys, CO2	Fraser Sweatman, Inc.	BSF	Class I	1976-07-16
K760052	Kit, Prep Shave	M-C Ind., Inc.	LDQ		1976-07-16
K760041	Filter, Respiratory (U-Mid)	BD Becton Dickinson Vacutainer Systems Preanalytic	CAH	Class II	1976-07-16
K760039	Valve, I.m.v. (U-Mid One Way)	BD Becton Dickinson Vacutainer Systems Preanalytic	CBO	Class II	1976-07-16
K760037	Heater, Immersion W/ Humidifier & Nebul.	Inspiron Corp.	BTT	Class II	1976-07-16
K760016	Surgical Blades (Beaver)	Parke-Davis Co.			1976-07-16
K760012	Blood Warmer (Code 4R4305)	Travenol Laboratories, S.A.	BSB	Class II	1976-07-16
K760113	Sponge, Laparotomy Gauze	Parke-Davis Co.	EFQ	Unclassified	1976-07-15
K760101	Oxygen & Resuscitation (Hope II Model)	Ohio Medical Products			1976-07-15
K760081	Filter, Bacteria (#2290)	Inspiron Corp.	CAH	Class II	1976-07-15
K760080	Cannula, Nasal, for Oxygen	Inspiron Corp.	CAT	Class I	1976-07-15
K261915	Navigator™ Flex Ureteral Access Sheath Set	Boston Scientific Corporation	FED	Class II
K261609	Freedom Partial Knee System	Maxx Orthopedics Inc.	HSX	Class II