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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2601 of 3530

510(k) clearances, page 2601 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K891988	Amplaid A308 Clinical Audiometer	Amplus Corp.	EWO	Class II	1989-10-12
K891786	Pti Intra-Art(r) Coronary Artery Probe (Sterile)	Pioneering Technologies, Inc.	DWP	Class II	1989-10-12
K891576	Fem-Flex Femoral Access Cannulation Set	Research Medical, Inc.	DWF	Class II	1989-10-12
K890993	Audiometer Ai1, Me1 and Sa1 & Master Hearing Aid	Maico Hearing Instruments, Inc.	EWO	Class II	1989-10-12
K882224	Ultrans Disposable Intrauterine	Telos Medical Corp.	HFN	Class II	1989-10-12
K895140	Custom in-the-Canal (Itc) Hearing Aid Model I54	Oticon, Inc.	ESD	Class I	1989-10-11
K894706	Ht-Res Rtp System	Philips North America LLC	IYE	Class II	1989-10-11
K894702	Stuart Cd Universal Rod Connector Clamps	Bio-Medical Prosthetics	KWP	Class II	1989-10-11
K892640	Pneumothorax Kit, Motification	Arrow Intl., Inc.	JDL	Class III	1989-10-11
K892499	Safety Surgeons Gloves	Advance Rubber, Inc.	KGO	Class I	1989-10-11
K892495	Surgeon's Gloves	Care-Pro Industries, Inc.	KGO	Class I	1989-10-11
K892450	Modified Suture Used in Catheter Insertion Trays	Quinton, Inc.	KGX	Class I	1989-10-11
K885313	Humidi-Flex Tm	Life Design Systems, Inc.	BYD	Class I	1989-10-11
K895705	Shamrock Safety Blood Collection Set	Ryan Medical, Inc.	FMI	Class II	1989-10-10
K895481	Shamrock Safety Winged Infusion Set	Ryan Medical, Inc.	FPA	Class II	1989-10-10
K895448	Rubber Latex Surgical Gloves, Sterile	Dah Lee Rubber Industries (Thai), Ltd.	KGO	Class I	1989-10-10
K895127	Argos	Abx, Inc.	GKZ	Class II	1989-10-10
K895102	Biotrack Pds Monitor	Biotrack, Inc.	JJQ	Class I	1989-10-10
K895101	Biotrack Hemoglobin Test Cartridge	Biotrack, Inc.	KHG	Class II	1989-10-10
K895073	Pow-Ir Tip	Living Technology, Inc.	GEX	Class II	1989-10-10
K894977	Optilase Yag Model 1000 Surgical Laser System	Trimedyne, Inc.	GEX	Class II	1989-10-10
K894943	Clinigen Erythropoietin Human Serum Controls 1,2,3	Amgen, Inc.	GGT	Class II	1989-10-10
K894708	Pt Distal Tip Cement Spacer	Osteonics Corp.	JDK	Class II	1989-10-10
K894591	Gyneguide	Marlo Surgical Technology	GEX	Class II	1989-10-10
K894580	Gore-Tex Surgical Tape	W. L. Gore & Associates, Inc.	FTM	Class II	1989-10-10
K894502	Ammel Patient Examination Gloves	Mauricio Menconi	LYY	Class I	1989-10-10
K894472	Cross Round & Square Spinal Rods & Dist. Spinal	Buckman Co., Inc.	KWP	Class II	1989-10-10
K894189	Sceptor-New Antimicrobial Agent:ticar/clavu Acid	BD Becton Dickinson Vacutainer Systems Preanalytic	JWY	Class II	1989-10-10
K893598	Hydraulic Foot Operated Stool	Arthro-Medic, Inc.	GBB	Class I	1989-10-10
K893597	Hydraulic IV Pole	Arthro-Medic, Inc.	FOX	Class I	1989-10-10
K893537	Greenleaf Hand Impairment Evaluation System	Greenleaf Medical Systems, Inc.	LBB	Class II	1989-10-10
K891613	Overdenture Attachment	Implant Innovations International, Inc.	DZE	Class II	1989-10-10
K895603	S.s.t. Surgical Thimble	Healthcare Technologies Resources, Inc.	KGO	Class I	1989-10-06
K895594	Single Lumen O'neil Aspiration & Irrigation Needle	Go Medical Industries Pty., Ltd.	GDM	Class I	1989-10-06
K895551	Rocket Bone Marrow Needle	A & A Medical, Inc.	GDM	Class I	1989-10-06
K895527	The Needle Count and Sharps Disposal System	Quantitative Technologies, Inc.	FSM	Class I	1989-10-06
K895504	Abnormal Reference Plasma-IX	Medical Diagnostic Technologies, Inc.	GJT	Class II	1989-10-06
K895503	Abnormal Reference Plasma-VIII	Medical Diagnostic Technologies, Inc.	GJT	Class II	1989-10-06
K895404	Under Buttocks Drape	Medical Plastics, Inc.	KKX	Class II	1989-10-06
K895373	Hematology Control	Medical Specialties Intl., Inc.	JCN	Class II	1989-10-06
K895367	Intravenous Extension Set	Medical Product Specialists	FPA	Class II	1989-10-06
K895262	Normal Coagulation Control Plasma (Nccp)	Medical Diagnostic Technologies, Inc.	GIZ	Class II	1989-10-06
K895261	Abnormal Coagulation Control Plasma-2 (Accp-2)	Medical Diagnostic Technologies, Inc.	GGC	Class II	1989-10-06
K895260	Abnormal Coagulation Control Plasma-1 (Accp-1)	Medical Diagnostic Technologies, Inc.	GGC	Class II	1989-10-06
K895255	Aptt-P Reagent, a Particle Activated Reagent	Medical Diagnostic Technologies, Inc.	GFO	Class II	1989-10-06
K895181	Abl500 Blood Gas System	Radiometer America, Inc	CHL	Class II	1989-10-06
K895178	Technomed Pulsolith Laser System	Teknomed, Inc.	FFK	Class II	1989-10-06
K895160	Ortho *Apo a-1 Elisa Test System	Medical Marketing Consultants, Inc.	DEL	Class I	1989-10-06
K895128	Biotrack Alt Test Cartridge	Biotrack, Inc.	CJJ	Class I	1989-10-06
K895105	High Pressure Inert Plastic Columns for Clin. Use	Waters Chemical Products	DPM	Class I	1989-10-06