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 2026-11-02, 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 2495 of 3531

510(k) clearances, page 2495 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K904338	Icor Hch 4, Icor Hch 7	Icor AB	BYD	Class I	1990-12-04
K904149	Flexisys	Dornier Medtech America, Inc.	GEX	Class II	1990-12-04
K904139	Single Lumen Catheter Kits	Akcess Medical Products, Inc.	LFJ	Class II	1990-12-04
K904101	Cospan Continuous Spinal Anesthesia Tray	Kendall Healthcare Products Co. Div.Of Tyco Health	CAZ	Class II	1990-12-04
K904084	Rubella Igm Elisa Test	Gull Laboratories, Inc.	LFX	Class II	1990-12-04
K903921	Mte-T Radiogrphic/tomographic Elevating Table	Imt America, Inc.	IZZ	Class II	1990-12-04
K903882	Varicella-Zoster Virus Antibody Test Kit-Latex Agg	Viral Antigens, Inc.	GQW	Class II	1990-12-04
K903308	Transtat-Cmv(tm)	Ab Sangtec Medical	LFX	Class II	1990-12-04
K902796	Latex Examination Gloves	Ek Hong Rubber Industry (Thailand) Co., Ltd.	LYY	Class I	1990-12-04
K902752	Neuritor 2001	Imexco General, Ltd.	GWQ	Class II	1990-12-04
K905086	Hpi Tri-Rads Vinyl Radiation Protection Gloves	Hpi, Inc.	IWP	Class I	1990-12-03
K904608	Percutaneous Introducer Tray	Merit Medical Systems, Inc.	DQY	Class II	1990-12-03
K904462	Model #210 Stealth Defib Pads	Cardiotronics, Inc.	LDD	Class II	1990-12-03
K904394	Inflation/deflation Device	Boston Scientific Corporation	MAV	Class II	1990-12-03
K904212	High-Pressure Connector Tube	Mallinckrodt Medical	DXT	Class II	1990-12-03
K903964	Ochsner 50 Bifurcation	Intervascular, Inc.	DSY	Class II	1990-12-03
K903018	Medtronic Andover Medical Saf-D-Fib Model 1220-002	Medtronic Andover Medical, Inc.	LDD	Class II	1990-12-03
K902845	Gentle Header	Enhanced Perfusion Systems, Inc.	DWE	Class II	1990-12-03
K902695	Disposable Inflation Gauge	Cook Incorporated	MAV	Class II	1990-12-03
K902612	Cordis Cinch(tm) Steer Guidewire Exten W/slx Coat	Cordis US Corp.	DQX	Class II	1990-12-03
K902587	Schneider Monorail-Gex(tm) Guidewire Exchange Cath	Schneider Intl., Ltd.	DQY	Class II	1990-12-03
K902475	Cardio-Pak Angiography Custom Packs	Cardio-Pak	DXT	Class II	1990-12-03
K902367	Opti-Plast 7F Peripheral Angioplasty Catheter	Vas-Cath, Inc.	LIT	Class II	1990-12-03
K902317	Percutaneous Transluminal Angioplasty (Pta) Cath.	Mallinckrodt Medical	LIT	Class II	1990-12-03
K901502	Amplatz Goose-Neck Snare	Microvena Corp.	DXE	Class II	1990-12-03
K900560	Acuson Heartsound/pulse/respiration Module	Acuson Corp.	DQC	Class I	1990-12-03
K896437	Kontron Sigma 44 Hvcd Ultrasound Imaging System	Kontron Instruments, Inc.	DPT	Class II	1990-12-03
K905244	Model Lp6 Ventilator, Modification	Aequitron Medical, Inc.	CBK	Class II	1990-11-30
K904539	Flagen Tm Free T4	Cyberfluor, Inc.	CEC	Class II	1990-11-30
K903887	Curity Nerve Block Tray	Kendall Healthcare Products Co. Div.Of Tyco Health	CAZ	Class II	1990-11-30
K903041	A-1107 Abutment (Fixed)	Minimatic Implant Technology	DZE	Class II	1990-11-30
K903010	Continuous Volume Ventilator Model Lp10	Aequitron Medical, Inc.	CBK	Class II	1990-11-30
K901147	Joslyn Steam Sterilizer / Steam Modernization Kit	Joslyn Valve Corp.	FLE	Class II	1990-11-30
K905161	Rubber Latex Surgical Gloves, Sterile	Rfb Latex Pvt., Ltd.	KGO	Class I	1990-11-29
K905128	Flexi-Trak(tm) Anchoring Device	Convatec, A Division of E.R. Squibb & Sons	KNY	Class II	1990-11-29
K904822	Elegance Ferritin Elisa	Bioclone Australia Pty, Ltd.	DBF	Class II	1990-11-29
K904661	Ivt Rast Tracer	In Vitro Technologies, Inc.	DHB	Class II	1990-11-29
K904536	Jain Graft Assist	Jain Surgical Equipment, Inc.	GCZ	Class I	1990-11-29
K904482	Stat.br Tm	Kerr Corporation (Danbury)	ELW	Class II	1990-11-29
K904193	Flocare	Flocare Medical	BYD	Class I	1990-11-29
K904187	Economy C-Arm Table, Model # 056-005	Atomic Products Corp.	IXQ	Class II	1990-11-29
K904158	Accorde(r) Irrigating Syringe/procedure Tray	Welcon, Inc.	FCM	Class II	1990-11-29
K904044	Tf-63Sa	Toshiba America Medical Systems, In.C	KPW	Class II	1990-11-29
K904043	Kxo-80C/80d	Toshiba America Medical Systems, In.C	IZO	Class I	1990-11-29
K904012	Philips Integris I 2000 System	Philips North America LLC	JAA	Class II	1990-11-29
K904005	Huestis Flexi-Board	Huestis Machine Corp.	JAD	Class II	1990-11-29
K904003	Hemochron(r) Heparin Response Test	Intensive Technology, Inc.	KFF	Class II	1990-11-29
K903373	Catheterization C-Arm Support Mh-51C(f)	Shimadzu Medical Systems	IZI	Class II	1990-11-29
K903372	Cath Multidirect Bi-Plane Radio Syst Mh-51A/mh-31A	Shimadzu Medical Systems	IZI	Class II	1990-11-29
K903371	Catheterization C-Arm Support Mh-51B(f)	Shimadzu Medical Systems	IZI	Class II	1990-11-29