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 922 of 3530

510(k) clearances, page 922 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K113242	Apex Arc Hip Stem	Omni Life Science, Inc.	LPH	Class II	2012-01-05
K113038	Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee System Instruments	Smith & Nephew, Inc.	HSX	Class II	2012-01-05
K113012	Promos Modular Shoulder System	Smith & Nephew, Inc.	KWS	Class II	2012-01-05
K112955	Nova Statstrip Lactate Hospital Meter System	Nova Biomedical Corporation	KHP	Class I	2012-01-05
K112557	Stryker Universal Neuro 3 System	Stryker Corp.	GWO	Class II	2012-01-05
K112458	Prospera Pro-I, Pro-II and Pro-III Negative Pressure Wound Therapy System	Medica-Rents Co., Ltd.	OMP	Class II	2012-01-05
K112454	Halo60 Ablation Catheter	Medtronic, Inc.	GEI	Class II	2012-01-05
K112035	Valet Micro Catheter	Volcano Corporation	DQY	Class II	2012-01-05
K111717	Electro-Gel	Electro-Cap Intl., Inc.	GYB	Class II	2012-01-05
K111103	Digital X-Ray Imaging System	Rf Co., Ltd.	MUH	Class II	2012-01-05
K113609	Novation Integrip Acetabular Augments, Groups 4 and 5	Exactech, Inc.	LPH	Class II	2012-01-04
K113589	Bigboss Catheter	Boston Scientific Corporation	DQY	Class II	2012-01-04
K113237	Certus 140 2.45Ghz Ablation System	Neuwave Medical, Inc.	NEY	Class II	2012-01-04
K113211	Hemosil La Positive Control & Hemosil La Negative Control	Instrumentation Laboratory Co.	GGN	Class II	2012-01-04
K113187	Avivo Mobile Patient Management	Corventis, Inc.	MHX	Class II	2012-01-04
K113106	Dne External Fixation System	Dne, LLC	KTT	Class II	2012-01-04
K112890	Normatec Mvp	Normatec Industries, LP	IRP	Class II	2012-01-04
K112643	Focus Mis System	L&K Biomed Co.,Ltd.	NKB	Class II	2012-01-04
K112240	Dyna Locking Cannulated Screw	CG MedTech Co., Ltd.	HWC	Class II	2012-01-04
K113373	Dimension Vista Loci 9 Calibrator- Loci 9 Cal	Siemens Healthcare Diagnostics Inc.	JIT	Class II	2011-12-30
K113337	Visia Dynamic Review	Mevis Medical Solutions AG	LNH	Class II	2011-12-30
K112944	Fresenius Medical Treatment Chair T688 Series	Fresenius Medical Care South Asia Pacific Pty, Ltd.	INO	Class II	2011-12-30
K112522	Flexstent Biliary Self-Expanding Stent System	Flexible Stenting Solutions, Inc.	FGE	Class II	2011-12-30
K111985	Myoguide System Model 8008	Intronix Technologies Corp.	BXN	Class II	2011-12-30
K111403	Masimo Rainbow Set Pronto-7 Pulse Co-Oximeter and Accessories	Masimo Corporation	DQA	Class II	2011-12-30
K111149	Hanarostent Biliary (Nnn)	M.I.Tech Co Ltd	FGE	Class II	2011-12-30
K111068	Stablyx Cmc Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5	Skeletal Dynamics, Inc	KYI	Class II	2011-12-30
K113690	Ge Logiq I, Logiq E and Vivid E	GE Healthcare	IYN	Class II	2011-12-29
K113680	Soma Access Systems Exacttrack Procedure Kit	Innovatus Imaging Corporation	IYO	Class II	2011-12-29
K113630	Digital Flat Panel X-Ray Detector/1210sga	Rayence Co., Ltd.	MQB	Class II	2011-12-29
K113559	Ldr Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants	Ldr Spine USA	ODP	Class II	2011-12-29
K113381	Mysono U6 Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	IYN	Class II	2011-12-29
K113342	Somatom Definition Flash	Siemens Medical Solutions USA, Inc.	JAK	Class II	2011-12-29
K113269	Elittech Clinical Systems Alp Ifcc Sl	ELITechGroup Inc	CJE	Class II	2011-12-29
K112914	Vpap Tx	ResMed Corp	MNS	Class II	2011-12-29
K112778	Smart Segmentation-Knowledge Based Contouring	Varian Medical Systems, Inc.	IYE	Class II	2011-12-29
K112543	Wallflex Biliary Transhepatic Uncovered Stent System, Wallflex Biliary Transhepatic Covered Stent System	Boston Scientific Corporation	FGE	Class II	2011-12-29
K102999	Trimotion Injector	KANEKA Corporation	OTZ	Class I	2011-12-29
K113317	Lifechoice Oxygen Concentrator	Inova Labs, Inc.	CAW	Class II	2011-12-28
K113283	Nnc Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,nnc Basal Screw Cementable Abutments	Straumann USA, LLC	NHA	Class II	2011-12-28
K113040	Ceramir Crown & Bridge	Doxa Dental AB	EMA	Class II	2011-12-28
K112572	Geistlich Combi-Kit Collegen	Geistlich Pharma AG	NPM	Class II	2011-12-28
K112080	Preserve Hip Stem	Wrightmedicaltechnologyinc	KWA	Class III	2011-12-28
K111776	Deltaview Model 2.1	Riverain Technologies	LLZ	Class II	2011-12-28
K111671	Seaspine Monopolar Probe Sysyem	Seaspine, Inc.	ETN	Class II	2011-12-28
K111618	Audx Otoacoustic Emissions Measurement System with Audx I/o Function	Natus Medical Incorporated	EWO	Class II	2011-12-28
K110639	Endowrist One Vessel Sealer	Intuitive Surgical, Inc.	NAY	Class II	2011-12-28
K103573	Arts2 Spinal Fixation System	Advanced Medical Technologies AG	MNH	Class II	2011-12-28
K112933	Access Thyroglobulin Anitbody	Siemens Healthcare Diagnostics Inc.	JNL	Class II	2011-12-27
K112923	Suspension Clavicle Fracture Fixation System	Suspension Orthopaedic Solutions, LLC	HRS	Class II	2011-12-27