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 3478 of 3526

510(k) clearances, page 3478 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K771443	Multistat III Creatinine Test	Instrumentation Laboratory Co.	CGX	Class II	1977-08-22
K771442	Multistat III Urea Nitrogen Test	Instrumentation Laboratory Co.	CDN	Class II	1977-08-22
K771441	Multistat III Cpk Test	Instrumentation Laboratory Co.	CGS	Class II	1977-08-22
K771434	Multi-Cavity Equilibrium Cell	Techhnilab Instruments, Inc.			1977-08-22
K771403	Ease (Modification to)	L.D. Caulk Co.	EJJ	Class II	1977-08-22
K771401	Prophy Paste	L.D. Caulk Co.	EJR	Class I	1977-08-22
K771400	Impregnated Dental Floss	L.D. Caulk Co.			1977-08-22
K771397	Monosticon Test	Organon LLC	KTN	Class II	1977-08-22
K771390	Histochemical Afb Demonstration	Harleco	ICL	Class I	1977-08-22
K771387	Monitoring Lines & Fluid Admin.	Norton Performance Plastics Corp.	FPK	Class II	1977-08-22
K771384	Autozyme Immobilized Enzyme Coil	Technicon Instruments Corp.	CFR	Class II	1977-08-22
K771362	Flu Ven 0150	Venospital, Inc.	FPA	Class II	1977-08-22
K771359	Allergist Pack Syringes	Pharmaseal Div., Baxter Healthcare Corp.	FMF	Class II	1977-08-22
K771346	Ci-Trol Coagulation Controls II & III	Dade, Baxter Travenol Diagnostics, Inc.	GGN	Class II	1977-08-22
K771308	Tissue-Tek III V.i.p.	Miles Laboratories, Inc.	IEO	Class I	1977-08-22
K771303	Flame Photometer Model 460	Corning Medical & Scientific	JIH	Class II	1977-08-22
K771259	Albumin Test, Hma Albumin Test	Hycel, Inc.	CIX	Class II	1977-08-22
K771201	Formalin Buffer Concentrate	Central Labs. Assoc. MD Pathologists	IGG	Class I	1977-08-22
K770994	Furnace Autosampler, Model 155	Instrumentation Laboratory Co.	DOP	Class I	1977-08-22
K771557	Ultrason 990	Litton Dental Products	ELC	Class II	1977-08-19
K771498	Continu-Flo Y-Type Solution Admin. Set	Travenol Laboratories, S.A.	FPB	Class II	1977-08-19
K771481	Tongue Blade Holder	Welch Allyn Inc	EMA	Class II	1977-08-19
K771433	Auto. Devel. Unit Foo Dental X-Ray	Ada Products Company, LLC	EGY	Class II	1977-08-19
K771395	Laparotomy Sponges, Sterile	MEDLINE INDUSTRIES, LP - Northfield	GDY	Class I	1977-08-19
K771350	Ambu Resuscitator	Air-Shields, Inc.	BTM	Class II	1977-08-19
K770966	Internal Ecology Machine	Holistic Equipment, Inc.	KPL	Class II	1977-08-18
K771529	Peritoneal Introducer & Sheath	Cordis US Corp.	GYK	Class I	1977-08-16
K771528	Catheter, Cardiac Pacing, Endocardial	American Technology, Inc.	DTB	Class III	1977-08-16
K771527	Accu. Crown Cold Cure	Parker Laboratories, Inc.	EBG	Class II	1977-08-16
K771522	Forceps, Style #849	Premier Dental Products Co	EMH	Class I	1977-08-16
K771518	Inspiratory Force Adaptor	Vital Flow Products Corp.	CAI	Class I	1977-08-16
K771516	Capillary Sample Line	Mcgaw Respiratory Therapy	CCI	Class II	1977-08-16
K771510	Servo-Pak Molel 0030	Isothermal Systems, Inc.	BXA	Class I	1977-08-16
K771500	Pressurometer II	Del Mar Avionics	DXN	Class II	1977-08-16
K771499	Flexible Arterial Cannulae	3M Health Care, Sarns	DWF	Class II	1977-08-16
K771495	A.v. Fistula Needle Set (#361)	Sorensen Research	FIE	Class II	1977-08-16
K771494	A.v. Fistula Needle Set (354)	Sorensen Research	FIE	Class II	1977-08-16
K771493	A.v. Fistula Needle Set (#341)	Sorensen Research	FIE	Class II	1977-08-16
K771492	A.v. Fistula Needle Set (#351)	Sorensen Research	FIE	Class II	1977-08-16
K771491	A.v. Fistula Needle Set (#364)	Sorensen Research	FIE	Class II	1977-08-16
K771490	A.v. Fistula Needle Set (#344)	Sorensen Research	FIE	Class II	1977-08-16
K771485	Pet-Tv X-Ray Image Intensifier System	Diagnostic Information, Inc.	JAA	Class II	1977-08-16
K771454	Micro Syringe & Needle	Terumo America, Inc.			1977-08-16
K771451	Scutabond	Premier Dental Products Co	EMA	Class II	1977-08-16
K771444	Qualicheck Tm	The London Co.	JJS	Class I	1977-08-16
K771440	Macbick Conductive Gel - 000907	C.R. Bard Inc	GEI	Class II	1977-08-16
K771392	Accu-Trode (Disp. ECG Electrode)	Warner/Chilcott	DRX	Class II	1977-08-16
K771365	Creatinine Analysis Products	Abbott Medical	CGX	Class II	1977-08-16
K771358	Clinac 20	Varian Assoc., Inc.	IYE	Class II	1977-08-16
K771292	High-Speed Sector Scanning Ssl-52H	Toshiba Medical Systems	DXK	Class II	1977-08-16