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 803 of 3530

510(k) clearances, page 803 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K130861	Monoclonal Mouse Anti-Human Progesterone Receptor, Clone Pgr 636, Ready-to-Use (Link)	Agilent Technologies, Inc.	MXZ	Class II	2013-12-09
K130394	Cadd -Solis Ambulatory Infusion Pump, Version 3.0	Abbott Medical	MEA	Class II	2013-12-09
K133372	Crosstrees Pva Pod	Crosstrees Medical, Inc.	NDN	Class II	2013-12-06
K133356	Prolene Polypropylene Nonabsorbable Suture	Ethicon, Inc	GAW	Class II	2013-12-06
K133207	Staxx(r) System	Spine Wave Inc	MQP	Class II	2013-12-06
K133043	Proteus Pta Balloon Catheter with Embolic Capture Feature	Angioslide, Ltd.	LIT	Class II	2013-12-06
K133029	Abdominal Aortic and Junctional Tourniquet (Aajt) Device	Compression Works Inc.	DXC	Class II	2013-12-06
K132967	3B Resmart CPAP and Auto CPAP, Bmc Resmart CPAP and Auto CPAP	3B Medical Inc	BZD	Class II	2013-12-06
K132519	Stryker Customized Mandible Recon Plate Kit	Stryker Corp.	JEY	Class II	2013-12-06
K132445	Piezon 250	E.M.S. - Electro Medical Systems SA	ELC	Class II	2013-12-06
K132429	Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia Exchange Disposable Set	Terumobct, Inc.	LKN	Unclassified	2013-12-06
K132395	Ligapass	Medicrea International	OWI	Class II	2013-12-06
K132328	Cd Horizon Spinal System	Medtronic Sofamor Danek USA Inc	NKB	Class II	2013-12-06
K132242	Inno Sla Submerged Implant System	Cowellmedi Co., Ltd.	DZE	Class II	2013-12-06
K132202	Dc Series Fluid Warming Cabinet, Dc Series Fluid Warming Cabinet	Enthermics Medical Systems, Inc.	LGZ	Class II	2013-12-06
K132185	Family of Coolglide Aesthetic Lasers	Cutera Inc	GEX	Class II	2013-12-06
K131851	Osteomed Neuro Rongeur	Osteomed	HAE	Class II	2013-12-06
K131702	K Series CPAP Systems	Curative Medical, Inc.	BZD	Class II	2013-12-06
K131550	Heart Sync	Graphic Controls Acquisition Corp.dba Nissha Medical Technologies	MKJ	Class III	2013-12-06
K131006	Anesthesia Conduction Needles	Lccs Products Limited	BSP	Class II	2013-12-06
K130669	Single Use & Multi Use Bipolar Forceps / Single Use & Multi Use Monopolar Forceps	Olsen Medical	GEI	Class II	2013-12-06
K130004	Ultraflex Esophageal Ng Stent System	Boston Scientific Corporation	ESW	Class II	2013-12-06
K133425	Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight Tip Surgical Light	Engineered Medical Solutions Co., LLC	FTD	Class II	2013-12-05
K133411	Alere Binaxnow Influenza a & B Card	Alere Scarborough, Inc D/B/A Binax, Inc.	GNX	Class I	2013-12-05
K133376	Aequalis Humeral Nail; Sizes 7Mm & 8Mm X 210, 230, 250, 270Mm; Left and Right	TORNIER Inc.	HSB	Class II	2013-12-05
K133213	Starceram	H.C. Starck Ceramics GmbH	EIH	Class II	2013-12-05
K132994	Anodyne Anterior Cervical Plate System	Corelink, LLC	KWQ	Class II	2013-12-05
K132966	Gluneo Lite Glucose Monitoring System, Gluneo Lite Professional Blood Glucose Monitoring System	Infopia Co, Ltd.	NBW	Class II	2013-12-05
K132904	Ziehm Vision Rfd	Ziehm Imaging GmbH	JAA	Class II	2013-12-05
K132640	Iuni Unicondylar Knee Replacement System	ConforMIS, Inc.	HSX	Class II	2013-12-05
K132285	Aequalis Reversed Shoulder Prosthesis	Tornier S.A.S.	PHX	Class II	2013-12-05
K132153	Safetouch Psv Winged Infusion Set With/without Filter	Nipro Medical Corporation	FOZ	Class II	2013-12-05
K132082	Aeskulisa Dgp-a, Aeskulisa Dgp-G,aeskulisa Dgp-Check	Aesku Diagnostics	MST	Class II	2013-12-05
K132079	Tfcc Fast-Fix Kit	Smith & Nephew, Inc.	GAT	Class II	2013-12-05
K131682	Ud Implant System	Medimecca Co Ltd	DZE	Class II	2013-12-05
K131497	Mckesson Cardiology Hemo	Change Healthcare Israel Ltd.	MWI	Class II	2013-12-05
K131229	Sparc System and Monarc, Monarc, and Monarc C Systems	American Medical Systems, Inc.	OTN	Class II	2013-12-05
K131095	Deka Synchro Repla: Y Family of Laser Systems	El.en. Electronic Engineering SpA	GEX	Class II	2013-12-05
K130788	Capella	Future Mobility Healthcare Inc.	IOR	Class I	2013-12-05
K130467	Porous Morphix Suture Anchor with Force Fiber Suture	Medshape, Inc.	MBI	Class II	2013-12-05
K121177	Bond Apatite	Augma Biomaterials	LYC	Class II	2013-12-05
K132828	Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3	Roche Diagnostics GmbH	JKR	Class II	2013-12-04
K132748	Beautifil E Posterior, Beautifil Bulk	Shofu Dental Corp.	EBF	Class II	2013-12-04
K132604	Vital Sync Informatics Manager & Virtual Patient Monitoring Platform	Medtronic, Inc.	MWI	Class II	2013-12-04
K132584	Perimeter C Spinal System	Medtronic Sofamor Danek USA Inc	ODP	Class II	2013-12-04
K132533	Carescape Monitor B450	GE Healthcare Finland Oy	MHX	Class II	2013-12-04
K132466	Mylabseven 6400, Mylabalpha 7400	Esaote S.p.A.	IYN	Class II	2013-12-04
K132437	Mars Holter Analysis Workstation	GE Medical Systems Information Technologies, Inc.	DQK	Class II	2013-12-04
K132232	Mins Needlescopic Resposable Device System	Minilap Technologies	OCW	Class II	2013-12-04
K132148	S Health	Samsung Electronics Co., Ltd.	DRG	Class II	2013-12-04