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 3495 of 3526

510(k) clearances, page 3495 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K770174	Luer-Lock Extension Set	American Viggo	FPK	Class II	1977-03-30
K770171	Erika i.v. Administration Set	Erika, Inc.	FPA	Class II	1977-03-30
K770163	Suture Cutter	Concept, Inc.	JOK	Class I	1977-03-30
K770066	Tibial Compression Fram for Fractures	Richard F. Kronner, M.D.	JEC	Class II	1977-03-30
K770521	Electrocardiographic Electrodes, Disp.	Dobre, Inc.	DRX	Class II	1977-03-29
K770559	C-L0l Cardiac Pacemaker	Coratomic, Inc.	DXY	Class III	1977-03-28
K770466	Stockings, Rvs Tm	Parke-Davis Co.	EQL	Class I	1977-03-28
K770214	Temp. Pervenous Lead W/remote Anode	Cordis US Corp.	DTB	Class III	1977-03-28
K761289	Ultra Logic 800 Hematology Ana. (Ul-800)	BD Becton Dickinson Vacutainer Systems Preanalytic	GKL	Class II	1977-03-28
K770562	Handler Catheter	Janet Beach, Ltd.	KOD	Class II	1977-03-24
K770557	Drainage Bag, 4000 Ml.	Concord Laboratories, Inc.	KNX	Class II	1977-03-24
K770556	Pro-Kup	Dental Control Products	EHK	Class I	1977-03-24
K770553	Audiometer, Diag., Advanced, Ma-22	Maico Hearing Instruments, Inc.	EWO	Class II	1977-03-24
K770545	Dura-Vac	Williams Gold Refining Co., Inc.			1977-03-24
K770471	Kerboull-Charnley Cup Special Model	Howmedica Corp.	JDG	Class II	1977-03-24
K770463	Mask, Surgical, Face, Disposable	Precept, Inc.	FXX	Class II	1977-03-23
K770437	Table, Examination	I E Industries	KNC	Class II	1977-03-23
K770418	Retractor, Skin Hook	Acme United Corp.	GAD	Class I	1977-03-23
K770396	Drapes, Modesty	Mark One Healthcare Products	KKX	Class II	1977-03-23
K760997	Under Bottocks Drape	C.R. Bard Inc	KKX	Class II	1977-03-23
K770107	Seri-Sep	Torval Corp.	JKA	Class II	1977-03-22
K770076	Bio-Dyes Fort. Wrights Stain Hemat. Pack	Jack W. Kindberg	KPA	Class I	1977-03-22
K770075	Bio-Dyes Hematology Phosphate	Jack W. Kindberg	IAF	Class I	1977-03-22
K770074	Bio-Dyes Fortified Hematology Stain	Jack W. Kindberg	IAF	Class I	1977-03-22
K770497	Drainage Unit, Combination	Concord Laboratories, Inc.	KNX	Class II	1977-03-21
K770496	Universal Tray	Concord Laboratories, Inc.	FCM	Class II	1977-03-21
K770493	Travacath	Travenol Laboratories, S.A.	KOD	Class II	1977-03-21
K770492	Crack Detector, Den-Mat	Dey-Mat, Inc.	EFH	Class I	1977-03-21
K770490	Drainage Bag, Improved, Flat	Pharmaseal Div., Baxter Healthcare Corp.	KNX	Class II	1977-03-21
K770489	Catheter with Hard Valve	Pharmaseal Div., Baxter Healthcare Corp.	KOD	Class II	1977-03-21
K770487	Lightweight Plastic Cannula	Hudson Oxygen Therapy Sales Co.	CAT	Class I	1977-03-21
K770484	Fluor. Conjugated Antiserum	Kent Laboratories, Inc.	DEW	Class II	1977-03-21
K770395	Thrombo-Cetin (Ristocetin)	Bay Area Hema. Onco. Clinic. & Res. L	JOZ	Class II	1977-03-21
K770386	Latelet, Control, Normal & Abnormal	BD Becton Dickinson Vacutainer Systems Preanalytic	JPK	Class II	1977-03-21
K761329	Mt II System - Serum Albumin	Technicon Instruments Corp.	CIX	Class II	1977-03-21
K761321	Vitamin B12 Radioassay	Kallestad Laboratories, Inc.	CDD	Class II	1977-03-21
K761310	Mega-Diastix	Miles Laboratories, Inc.	JIL	Class II	1977-03-21
K761306	Clinilab Automated Urinalysis System	Miles Laboratories, Inc.	KQO	Class I	1977-03-21
K770473	Lagrange Letournel Total Hip Femoral	Howmedica Corp.	JDG	Class II	1977-03-17
K770472	Prosthesis, Vidal Total Hip	Howmedica Corp.	JDL	Class III	1977-03-17
K770475	Pressure Transducer Isolater Code 5Ml6l2	Travenol Laboratories, S.A.	KOC	Class II	1977-03-16
K770469	Cutter Tungsten Carbide Burs	Cutter Laboratories, Inc.	EJL	Class I	1977-03-16
K770461	Anesthesia Kit, Epidural Block, Continu.	Arrow Intl., Inc.	CAZ	Class II	1977-03-16
K770432	Microflush	Medex, Inc.	KRA	Class II	1977-03-16
K770431	Catheter, Two Stage Venous Return	3M Health Care, Sarns	DWF	Class II	1977-03-16
K770430	Catheter, Curved Left Heart Vent	3M Health Care, Sarns	DWF	Class II	1977-03-16
K770429	Cannulae, Aortic, Arch, High Flow	3M Health Care, Sarns	DWF	Class II	1977-03-16
K770427	Catheter Introducer Kit	Electro-Catheter Corp.	DYB	Class II	1977-03-16
K770424	Oxygen Twmer, Model Sst	Timeter Instrument Corp.	BXP	Class I	1977-03-16
K770422	Catheter, Surflo, i.v.	Terumo America, Inc.	FOX	Class I	1977-03-16