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 3525 of 3526

510(k) clearances, page 3525 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K760161	Test, Acid Phosphatase	Princeton Biomedix	CJR	Class II	1976-07-20
K760159	Aggregometer, Dual Channel Platelet	Chrono-Log Corp.	JBX	Class II	1976-07-20
K760156	Test, (Ivdp) Smoothmuscle Antibody	Zeus Scientific LLC	DBE	Class II	1976-07-20
K760155	Test, (Ivdp) Mitochondrial Antibody	Zeus Scientific LLC	DBM	Class II	1976-07-20
K760154	Test, (Ivdp) Thyroid Antibody	Zeus Scientific LLC	JZO	Class II	1976-07-20
K760153	Test, (Ivdp) Antinuclear Antibody	Zeus Scientific LLC	DHN	Class II	1976-07-20
K760148	Serum, B1a Globulin C3c Goat Anti-Human	Oxford Laboratories, Inc.	CZW	Class II	1976-07-20
K760147	Serum, Igm Anti-Human Acid	Oxford Laboratories, Inc.	DFT	Class II	1976-07-20
K760146	Serum, Iga Goat Anti-Human Acid	Oxford Laboratories, Inc.	CZP	Class II	1976-07-20
K760144	Serum, Haptoglobin Goat Anti-Human Acid	Oxford Laboratories, Inc.	DAD	Class II	1976-07-20
K760143	Serum, Alpha-1-Glycoprotein Anti-Human	Oxford Laboratories, Inc.	DEX	Class I	1976-07-20
K760136	Catheter, Thoracic Drain	Sherwood Medical Industries	DWS	Class I	1976-07-20
K760135	Test, Ra, Quanta-Count T-4	Bio-Rad	CDX	Class II	1976-07-20
K760134	Procedure, Ra, Thyroxine Binding Protein	Bio-Rad	CEE	Class II	1976-07-20
K760133	Procedure, Red Cell Folate Assay	Bio-Rad	CGN	Class II	1976-07-20
K760132	Test, Ria, Tsh Quantimune	Bio-Rad	JLW	Class II	1976-07-20
K760131	Agaro-Gel, Product # A1266	Sigma Chemical Co.	JJN	Class I	1976-07-20
K760130	Prosthesis, Vascular Bifurcated	Usci, Div. C.R. Bard, Inc.	DSY	Class II	1976-07-20
K760129	Saline, Isotonic Buffered, Azide-Free	Harleco	GIF	Class I	1976-07-20
K760126	Lens, Hard Contact	Tru-Form Optics, Inc.	HPX	Unclassified	1976-07-20
K760124	Auto Cell Diluent	BD Becton Dickinson Vacutainer Systems Preanalytic	GIF	Class I	1976-07-20
K760123	Autozyme	BD Becton Dickinson Vacutainer Systems Preanalytic	KSK	Class II	1976-07-20
K760120	Pulse Cardule (Model 1859/1860 ECG)	Spacelabs, Inc.	DRT	Class II	1976-07-20
K760119	Sampler, Flameless (Il Model 555)	Instrumentation Laboratory Co.	JXR	Class I	1976-07-20
K760118	Thermometer, Digital Fever (Meditemp)	Johnson & Johnson Professionals, Inc.	FLL	Class II	1976-07-20
K760109	Prosthesis, Total Hip-Rasp	Orthopedic Equipment Co., Inc.	HTR	Class I	1976-07-20
K760108	Prosthesis, Total Hip-Test Cup	Orthopedic Equipment Co., Inc.	JDG	Class II	1976-07-20
K760107	Prosthesis, Total Hip-Test Femoral	Orthopedic Equipment Co., Inc.	JDG	Class II	1976-07-20
K760106	Prosthesis, Total Hip-Femoral	Orthopedic Equipment Co., Inc.	JDG	Class II	1976-07-20
K760095	Respirizor	Campillary Systems	CAF	Class II	1976-07-20
K760092	Graft, Cooley Woven Vascular, Sterile	Meadox Medicals, Div. Boston Scientific Corp.	DSY	Class II	1976-07-20
K760091	Graft, Microvel Guideline, Sterile	Meadox Medicals, Div. Boston Scientific Corp.	DSY	Class II	1976-07-20
K760090	Graft, Cooley Guideline, Sterile	Meadox Medicals, Div. Boston Scientific Corp.	DSY	Class II	1976-07-20
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