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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1861 of 3531

510(k) clearances, page 1861 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K972655	Control Syringe	Medical Specialties Intl., Inc.	IZI	Class II	1997-11-04
K972518	Transit/rapidtransit/speedster/prowler Infusion Catheter	Cordis Neurovascular, Inc.	KRA	Class II	1997-11-04
K971857	Mumps Igg Elisa Testy	Gull Laboratories, Inc.	LJY	Class I	1997-11-04
K971134	Vista Eyeshower	John Branch	LXQ	Unclassified	1997-11-04
K970853	Pathfinder 3Mm Mapping Microcatheter (01-082001)	Cardima, Inc.	DRF	Class II	1997-11-04
K970488	Hydrocheck Micro Filter	White River Concepts	HGX	Class II	1997-11-04
K970352	Smartvac Smoke Evacuation System	Isomedix Operations Inc	FYD	Class II	1997-11-04
K964397	Therapik	The Jenex Corporation	ILY	Class II	1997-11-04
K964185	Imx Ca 125	Abbott Diagnostics	LTK	Class II	1997-11-04
K964020	Axsym Ca 125	Abbott Medical	LTK	Class II	1997-11-04
K963957	Trinity Dvt System	Delphi Consulting Group	JOW	Class II	1997-11-04
K953893	Paratrend 7 Intravascular Blood Gas Monitoring System	Biomedical Sensors, Inc.	CCC	Class II	1997-11-04
K973627	Standard Volume Processing Set for the Cobe Brat 2 Autologous Blood Salvage System	LivaNova USA, Inc.	CAC	Class II	1997-11-03
K973565	Quick-Care Biopsy Needle	Cook Inc.	KNW	Class II	1997-11-03
K973378	C.a.t.s Continuous Autotransfusion System Model 900500 1, At1 Autotransfusion Set Model 900 510 1, Psq Set (Dd) Model 61	Fresenius USA, Inc.	CAC	Class II	1997-11-03
K973281	The Surgical Dynamics* S.d. Sorb* E-Z Tac*	United States Surgical, A Division of Tyco Healthc	MAI	Class II	1997-11-03
K973124	Apr Porous Ha Hip System	Sulzer Orthopedics, Inc.	LPH	Class II	1997-11-03
K973060	Depuy Motech Profile Anterior Thoracolumbar Plate System	Depuy, Inc.	KWQ	Class II	1997-11-03
K973031	Stabilizer Soft Tissue Anchor 5Mm Model Ta1005, Anchor Inserter/suture Organizer 5Mm Ai1005, Stabilizer Drill 5Mm Nonste	R. Thomas Grotz, M.D., Inc.	MRI	Class I	1997-11-03
K973023	Incare Hot/ice System Foot/ankle Blanket	Hollister, Inc.	ILO	Class II	1997-11-03
K972994	External Csf Drainage Management Systems	Integra Neurocare, LLC	JXG	Class II	1997-11-03
K972944	Medtronic Mustang Super Floppy Guide Wire/floppy Guide Wire/intermediate Guide Wire/standard Guide Wire/extra Support	Medtronics Interventional Vascular	DQX	Class II	1997-11-03
K972928	Kerboull Cross	Howmedica Corp.	JDI	Class II	1997-11-03
K972893	Partnership Revision Femoral Stems	Howmedica Corp.	LZO	Class II	1997-11-03
K972537	Erco-Vac	Ercons, Inc.	LKY	Class II	1997-11-03
K971912	Protege Er:yag Laser System and Accessories	Xintec Corporation	GEX	Class II	1997-11-03
K971730	Depuy Motech Peak Polyaxial Anterior Cervical Plate System	Depuy, Inc.	KWQ	Class II	1997-11-03
K971719	Therox Infusion Guidewires	Therox, Inc.	DQX	Class II	1997-11-03
K964926	Bath Air Spa Fixed Height Hydraulic Operated/adjustable Height Hydraulic/fixed Height Electric Reclining/height Electric	Joerns Healthcare	ILJ	Class II	1997-11-03
K955808	Dyna T-2000 Physical Therapy System	Thermia, Inc.	IMB	Class II	1997-11-03
K973966	Access Total T3 Reagents on the Access Immunoassay Analyzer	Beckman Instruments, Inc.	CDP	Class II	1997-10-31
K973743	Access Estradiol Reagents on the Access Immunoassay Analyzer	Beckman Instruments, Inc.	CHP	Class I	1997-10-31
K973570	Quick Card Hcg One Step Pregnancy Test	Phamatech Inc.	LCX	Class II	1997-10-31
K973514	Active Intact Pth	Diagnostic Systems Laboratories, Inc.	CEW	Class II	1997-10-31
K973274	Accucolor High Calibrator (A3089)	Sigma Diagnostics, Inc.	GIZ	Class II	1997-10-31
K973140	Duet Glucose Control Monitoring System	Lxn Corp.	CGA	Class II	1997-10-31
K972882	Apollo	Norland Corp.	KGI	Class II	1997-10-31
K972862	Amplaid 171S	Amplifon	EWO	Class II	1997-10-31
K972860	Curvtek Tsr System	Biolectron, Inc.	HSZ	Class I	1997-10-31
K972021	Immulite Third Generation Psa (Lkupi,lkup5)	Siemens Healthcare Diagnostics Inc.	LTJ	Class II	1997-10-31
K971375	Greatbatch Scientific Mr Compatible Sinuscope	Wilson Greatbatch Technologies, Inc.	EOB	Class II	1997-10-31
K970756	Mercury Medical Reusable CPR Bag	Mercury Medical	BTM	Class II	1997-10-31
K970482	Transcom Colon Hydrotherapy Model Hc-2000	Srs Intl.	KPL	Class II	1997-10-31
K965141	Truquant Br Ria	Biomira USA, Inc.	MOI	Class II	1997-10-31
K964210	Retriever II	Target Therapeutics	DQO	Class II	1997-10-31
K964098	Cpa 125 II Assay for the Technicon Immuno 1 System	Bayer Corp.	LTK	Class II	1997-10-31
K963967	Glycar Pericardial Patch	Glycar SA Pty., Ltd.	DXZ	Class II	1997-10-31
K963368	Glycartissue Repair Patch Family of Products; Glycar Vascular Repair Patch Alternative Proprietary Name Possible	Glycar SA Pty., Ltd.	DXZ	Class II	1997-10-31
K973539	Roeko Calcium Hydroxide Points	Roeko USA, Inc.	EJK	Class II	1997-10-30
K973253	Rockwell Medical Supply, Llc. Concentrate Solutions for Acetate Dialysate	International Medical Products, Inc.	KPO	Class II	1997-10-30