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 3251 of 3528

510(k) clearances, page 3251 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K813220	Regu-Vac Oxygenating Suction Catheter	BD Becton Dickinson Vacutainer Systems Preanalytic			1982-01-22
K813174	Bradycardia Alarm	Douglas Scientific Products	DRT	Class II	1982-01-22
K813127	Sodium & Potassium Products	Alko Diagnostic Corp.	JIX	Class II	1982-01-22
K813000	Disposable Arthroscopy Cannula Set	Clinical Technology Inc.	LXH	Class I	1982-01-22
K812986	Agglutex Amphetamine Test Kit	Hoffmann-La Roche, Inc.	DJP	Class II	1982-01-22
K812959	Spirox a	Cairco, Ltd.	BZK	Class II	1982-01-22
K812956	Spirox H	Cairco, Ltd.	BZK	Class II	1982-01-22
K813636	Bk-6470 Adjustable Elevating Wheelchair	Fred Sammons, Inc.	KNN	Class I	1982-01-19
K813635	Childs Toilet Trainer Hygiene Aids	Fred Sammons, Inc.	ILS	Class I	1982-01-19
K813634	One Handed Shoe Fastener	Fred Sammons, Inc.	ILD	Class I	1982-01-19
K813633	Modeling Compound and Foam Exerciser	Fred Sammons, Inc.	ION	Class I	1982-01-19
K813632	Color Coded Weight Cuffs	Fred Sammons, Inc.	IOD	Class I	1982-01-19
K813631	Jar Holder & Opener	Fred Sammons, Inc.	IKW	Class I	1982-01-19
K813630	Bk-1129 Bottle Straw	Fred Sammons, Inc.	ILC	Class I	1982-01-19
K813629	Bk-6111 Hi-D Transfer Board	Fred Sammons, Inc.	IKX	Class I	1982-01-19
K813628	Bk-7182 Instant Cold Pack	Fred Sammons, Inc.	IMD	Class I	1982-01-19
K813627	Bk-6453 Rimmed Acrylic Lap Tray Kit	Fred Sammons, Inc.	KNO	Class I	1982-01-19
K813557	Auditory Stimulator	Western Advanced Technology, Inc.	ETS	Class II	1982-01-19
K813515	Veri/dfs Tm #817	Verite	GZI	Class II	1982-01-19
K813364	Medical Tape (Multiple)	Cederroth, Inc. USA	KGX	Class I	1982-01-19
K813330	Post-Auricular Hearing Aid Model S-101	Telesonic, Inc.	ESD	Class I	1982-01-19
K813329	Post-Auricular Hearing Aid Model P-101	Telesonic, Inc.	ESD	Class I	1982-01-19
K813305	Conphar Otoscope	Conphar, Inc.	ERA	Class I	1982-01-19
K813299	Conphar Otoscope/opthalmascope	Conphar, Inc.	ERA	Class I	1982-01-19
K813158	Rdp-2000	Machlett Laboratories, Inc.	JAA	Class II	1982-01-19
K812984	Slimtronics 2000	Ems Dist.	IPF	Class II	1982-01-19
K812925	Abbott Pap-Eia	Abbott Medical	JFH	Class II	1982-01-19
K812752	Micro Med Int'l Micro Sound US-100	N-Tron Electronics	IMI	Class II	1982-01-19
K813606	Silicone Elastomer Infusion Catheter	Quest Medical, Inc	JCY	Class I	1982-01-18
K813595	Parke-Davis Aegis Abosrbent Sponges	Deseret Medical, Inc.	GDY	Class I	1982-01-18
K813592	Quantafluor Fluorescent Test Reagents	Kallestad Laboratories, Inc.	DHN	Class II	1982-01-18
K813589	Shartpoint Eyed Needles	S. Jackson, Inc.	GDL	Class I	1982-01-18
K813580	Q-Line Ltc	Miles Laboratories, Inc.	JJY	Class I	1982-01-18
K813578	Hemostatic Side-Arm Adapter	Advanced Catheter Systems	DYG	Class II	1982-01-18
K813575	Liquid Chromatography (Hplc) Columns	Supelco, Inc.	DPM	Class I	1982-01-18
K813573	Cardiotrac Corning Ck Isoenzyme Subst	Corning Medical & Scientific	JHX	Class II	1982-01-18
K813555	Glucose Enzyme-Color Reagent Set	Biorent Diagnostic, Inc.	CGA	Class II	1982-01-18
K813553	Pace *Aid	Cardiac Resucitator Corp.	DRO	Class II	1982-01-18
K813551	Sheets	Lancaster County Assoc. for the Blind	KKX	Class II	1982-01-18
K813416	External Breast Prosthesis	Surgical Appliance Industries, Inc.	GBI	Class I	1982-01-18
K813361	Adhesive Strip(multiple)	Cederroth, Inc. USA	KGX	Class I	1982-01-18
K813255	Lpm/50 Membrane Oxygenator	Travenol Laboratories, S.A.	DTZ	Class II	1982-01-18
K813030	O.r. Armboard Cover	Tecnol New Jersey Wound Care, Inc.	FWZ	Class I	1982-01-18
K812904	Sterile Orthopedic Stockinette	Alba Health Care	LGF	Class I	1982-01-18
K812830	Apc Implantable Pacing Lead	American Pacemaker Corp.	DTB	Class III	1982-01-18
K812807	Apc Implantable Pacing Leads	American Pacemaker Corp.	DTB	Class III	1982-01-18
K812793	P.e.t.	Hospital Equipment Service	DXH	Class II	1982-01-18
K812768	Coat-a-Count Free & Total Estriol Kit	Siemens Healthcare Diagnostics Inc.	CGI	Class I	1982-01-18
K812760	Hi-Temp Cardiovascular Cautery	Key Medical, Inc.	GEI	Class II	1982-01-18
K812134	Incision & Drainage Tray	E.M. Adams Co., Inc.	FSM	Class I	1982-01-15