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 3527 of 3528

510(k) clearances, page 3527 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K760089	Test, in-Vitro Diagnostic	Hoffmann-La Roche, Inc.			1976-07-20
K760087	Tape, Vascular, 1/4 Dacron	Meadox Medicals, Div. Boston Scientific Corp.	DWS	Class I	1976-07-20
K760085	Basin, Sterile (#3200)	Concord Laboratories, Inc.	FNY	Class I	1976-07-20
K760083	Physioscope	Narco Bio-Systems			1976-07-20
K760079	Reagent, Thyroxine T4 (#210)	Oxford Laboratories, Inc.	CDX	Class II	1976-07-20
K760078	Reagent, Ria Triiodothyronine T3 (#200)	Oxford Laboratories, Inc.	CDP	Class II	1976-07-20
K760075	Kit, Methadone (Toxi-Pak Immuno Hi)	J.T. Baker Chemical Co.	DIW	Class II	1976-07-20
K760074	Kit, Morphine (Toxi-Pak Immuno Hi)	J.T. Baker Chemical Co.	DLR	Class II	1976-07-20
K760073	Basin, Wash, 6-Qt Rectangular	Bemis Health Care	LDQ		1976-07-20
K760072	Carafe, Personal, 1-Qt Semi-Rectangular	Bemis Health Care			1976-07-20
K760071	Tray, Personal, Rectang. 8 1/2 X 5 1/4	Bemis Health Care			1976-07-20
K760070	Tumbler, Personal, Round, 9 Ounce	Bemis Health Care			1976-07-20
K760068	Kit, Ria, Gentamicin Sulf.	New England Nuclear	DJB	Class II	1976-07-20
K760045	Kit, Radioassay, Serum Iron	BD Becton Dickinson Vacutainer Systems Preanalytic	JJA	Class I	1976-07-20
K760031	Histochemical Pas Reaction Set	Harleco	HZT	Class I	1976-07-20
K760027	Dsp - Stain Pack	Harleco	IAF	Class I	1976-07-20
K760019	Vacuum Tubes, Pediatric Sizes (J-Vac)	Jelco Laboratories	GIM	Class II	1976-07-20
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