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 1305 of 3531

510(k) clearances, page 1305 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K042991	I-Neb Aad System	Profile Therapeutics PLC	CAF	Class II	2005-09-23
K052461	Syngo Imaging Version V20a	Siemens AG Medical Solutions	LLZ	Class II	2005-09-22
K052410	Acuson Sequoia Ultrasound System	Siemens Medical Solutions USA, Inc.	IYN	Class II	2005-09-22
K052372	Mc2x Multi-Stage Venous Cannula, Models 91437, 91437C	Medtronic Perfusion Systems	DWF	Class II	2005-09-22
K052315	Simtec Im-Maxx 2 Option	Siemens Medical Solutions USA, Inc.	LNH	Class II	2005-09-22
K052199	21.3-Inch(54 Cm) Monochrome Lcd Monitor Mdl2115a (Me353i), (Dv3mm-Hb), (Me353im)	Totoku Electric Co., Ltd.	LLZ	Class II	2005-09-22
K052134	Cystoglide Dilating Introducer Sheath	Percutaneous Systems, Inc.	KNY	Class II	2005-09-22
K052047	Isis Iq Uno Handheld Electronic Breast Pump, Model 101	Avent America, Inc.	HGX	Class II	2005-09-22
K051787	Triage Bnp Test, Model 98000Xr	Biosite Incorporated	NBC	Class II	2005-09-22
K052460	Powerserver, Powerreader, Gateway and Powercache	Ramsoft, Inc.	LLZ	Class II	2005-09-21
K052452	Visera Rhino-Laryngovideoscope Olympus Enf Type Vt	Olympus Medical Systems Corp.	EOB	Class II	2005-09-21
K052447	Synerad Impact 60, Synerad Impact 72 and Analogic Ams1600	Analogic Corp.	JAK	Class II	2005-09-21
K052441	Ge Logiq 7 Ultrasound Bt05	General Electric Co.	IYN	Class II	2005-09-21
K052411	Hipax Medical Imaging Software	Steinhart Medizinsysteme GmbH	LLZ	Class II	2005-09-21
K052332	Aerochamber Z-Stat Plus Valved Holding Chamber	Trudell Medical Intl.	NVP	Class II	2005-09-21
K052329	Walkaide System, Models 20-0100, 20-0310, 20-1000	Innovative Neurotronics, Inc.	GZI	Class II	2005-09-21
K052317	Modification to: Stryker Spine Oasys System	Howmedica Osteonics Corp	MNI	Class II	2005-09-21
K052293	Ge 1.5T and 3.0T Signa Hdx Mr System	GE Healthcare	LNH	Class II	2005-09-21
K052276	Nio 2Mp-20 and E-2620 S	Barco N.V.	LLZ	Class II	2005-09-21
K052274	Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model Vh-3000	Boston Scientific Corporation	GEI	Class II	2005-09-21
K052239	Ebi Dynafix Vision Footplate System	Ebi, LLC	KTT	Class II	2005-09-21
K052091	Sensitire Susceptibility Plates- Additional Antimicrobics	Trek Diagnostic Systems, Ltd.	JWY	Class II	2005-09-21
K051988	Oxy-Serve II Oxygen Conserving Regulator	Superior Products, LLC	NFB	Class II	2005-09-21
K051957	Reprocessed External Fixation Device	Sterilemed, Inc.	KTT	Class II	2005-09-21
K051938	Triton/tru-Trac/tx Traction Devices	Chattanooga Group, Inc.	ITH	Class II	2005-09-21
K051697	Selective-Axis Posterior Noncervical Plating System	Medical Device Advisory Development Group	MNH	Class II	2005-09-21
K051678	Synthes Hindfoot Arthrodesis Nail System	Synthes (USA) Products LLC	HSB	Class II	2005-09-21
K051540	Inovo, Inc. Independence Oxygen Conserving Regulator	Inovo, Inc.	NFB	Class II	2005-09-21
K051494	Medical Image Digitizer, Models Cdcr 5020S, Uccr7001 and Tccr 7001	Cr Tech, Ltd.	MQB	Class II	2005-09-21
K050807	20G Sma Laser Fiber, Model Lf100	Ophthalmed LLC	HQF	Class II	2005-09-21
K052444	Inion Cps Baby 1.5 Bioabsorbable Fixation System	Inion Oy	JEY	Class II	2005-09-20
K052419	Maximus 3.0 and Os Implants	BioHorizons Implant Systems Inc	DZE	Class II	2005-09-20
K052282	Venaflo II Vascular Graft	Bard Peripheral Vascular Inc	DSY	Class II	2005-09-20
K051873	Disposable Temperature, Skin and Esophageal Probes	GE Healthcare	FLL	Class II	2005-09-20
K051782	Bluephase 16I	Ivoclar Vivadent, Inc.	EBZ	Class II	2005-09-20
K051440	Mayfield Infinity Skull Clamp	Integra LifeSciences Corporation	HBL	Class II	2005-09-20
K051357	Ds7a Constant Current High Voltage Stimulator, Model Ds7a; Ds7ah Constant Current High Voltage Stimulator, Model Ds7ah	Digitimer Ltd.	GWF	Class II	2005-09-20
K051291	Non-Sterile Surgical Mask	A.R. Medicom, Inc.	FXX	Class II	2005-09-20
K051259	Versaclear Skin Therapy System, Model 100	Theralight, LLC	GEX	Class II	2005-09-20
K051750	Flor-Opal Varnish, Models Up 4500/ Up 4501/ Up 4502	Ultradent Products Inc.	LBH	Class II	2005-09-19
K051552	O.a.s.i. System	Lancer Orthodontics, Inc.	DZE	Class II	2005-09-19
K052412	Innova 2100-Iq, Innova 3100, Innova 3100-Iq, Innova 4100, and Innova 4100-Iq	GE Healthcare	OWB	Class II	2005-09-16
K052008	Imc Heartway - Power Wheelchair, Model Hp 7	Imc-Heart Way LLC	ITI	Class II	2005-09-16
K051885	Mbcp	Biomatlante	LYC	Class II	2005-09-16
K051830	Neurodrive System	Alpha Omega, Ltd.	GZL	Class II	2005-09-16
K051397	Biobands	Biobands Distributors, Inc.	MVV	Unclassified	2005-09-16
K052429	Coronis 3Mp-21 and Mfgd 3621	Barco N.V.	LLZ	Class II	2005-09-15
K052403	Coronis 2Mp-21 and Mfgd 2621	Barco N.V.	LLZ	Class II	2005-09-15
K052382	Powder Free Nitrile Examination Gloves, Blue	Pt.Shamrock Manufacturing Corp.	LZA	Class I	2005-09-15
K051997	Capiox Rx15 Hollow, Fiber Oxygenator With/without Hardshell Reservoir	Terumo Cardiovascular Systems Corporation	DTZ	Class II	2005-09-15