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 1562 of 3531

510(k) clearances, page 1562 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K013506	Yellow Special	Metalor Technologies USA	EJT	Class II	2002-01-03
K013319	Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor	Nonin Medical, Inc	DQA	Class II	2002-01-03
K013311	Modification to: Pocketview ECG Software	Micromedical Industries, Ltd.	MHX	Class II	2002-01-03
K013171	3420 Digit Pulse Oximeter, Model 3420	Bci, Inc.	DQA	Class II	2002-01-03
K011564	Neolead	Neotech Products, LLC	DRX	Class II	2002-01-03
K013514	Phsl-63 Pediatric Head and Spine Array Coil	Mri Devices Corp.	MOS	Class II	2002-01-02
K013304	Bd Introsyte Precision Introducer, Bd Introsyte Autogaurd Shielded Introducer	Becton Dickinson Infusion Therapy Systems Inc.	DBY	Class I	2002-01-02
K003689	Canon X-Ray Digital Camera, Model Cxdi-31	Canon Medical Components U.S.A., Inc.	IXK	Class II	2002-01-02
K014091	Stryker Painpump	Stryker Corp.	FRN	Class II	2001-12-31
K013942	Powder Free Blue Latex Examination Glove, Non-Sterile (Protein Content Labeling)	Wrp Specialty Products Sdn. Bhd.	LYY	Class I	2001-12-31
K013556	Monoject Prefill Heparin Lock Flush Syringe	Tyco Healthcare	FOZ	Class II	2001-12-31
K012839	Auropal, Order-No.: 2101	Wieland Edelmetalle GmbH & Co.	EJT	Class II	2001-12-31
K012029	Remedy Model 2Z12	Apollo Corp.	KMG	Class II	2001-12-31
K011202	Msi Bipolar Sheath	Medical Scientific, Inc.	HRX	Class II	2001-12-31
K013721	Synthetic Polysioprene Ultrasound Transducer Cover	CIVCO Medical Instruments Co., Inc.	ITX	Class II	2001-12-28
K013586	Magnetom Trio System	Siemens Medical Solutions USA, Inc.	LNH	Class II	2001-12-28
K014076	Modification to Tsrh Spinal System	Medtronic Sofamor Danek	MNH	Class II	2001-12-27
K013991	Prolong Highly Crosslinked Polyethtylene Cruciate Retaining (Cr) Articular Surface Components	Zimmer GmbH	JWH	Class II	2001-12-27
K013915	D902 Ph.i.s.i.o Oxygenator; D920 Ph.i.s.i.o Reservoir; Dideco D736 Ph.i.s.i.o Filter	Dideco S.p.A.	DTZ	Class II	2001-12-27
K013702	Victorch Hcg Test Strip	Victorch Meditek, Inc.	JHI	Class II	2001-12-27
K013678	Victorch Meditek's Hcg Test Card	Victorch Meditek, Inc.	DHA	Class II	2001-12-27
K013563	Long Trochanteric Nail System	Depuy Orthopaedics Inc.	HSB	Class II	2001-12-27
K013289	Bioteque Vaginal Pessaries	Bioteque America Inc	HHW	Class II	2001-12-27
K012183	Bayer Diagnostics Advia Centaur Toxoplasma Igg Assay	Bayer Diagnostics Corp.	LGD	Class II	2001-12-27
K011939	Fotona Dualis, Fotona Dualis Plus	Fotona D.D.	GEX	Class II	2001-12-27
K011887	Avalon Cup System	Orthopedic Source, Inc.	JDI	Class II	2001-12-27
K011691	Kimstim Auricular Electrode	Kim Institute for Rehabilitation Medicine, P.C.	GXY	Class II	2001-12-27
K011406	Spinal Mesh System	Medtronic Sofamor Danek	MQP	Class II	2001-12-27
K013649	Sauflon 55 UV Soft (Hydrophilic) Contact Lens	Sauflon Pharmaceuticals, Ltd.	LPL	Class II	2001-12-26
K013591	Xenf-Tp Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment	Olympus Optical Co., Ltd.	EOB	Class II	2001-12-26
K013549	Sigma Diagnostics Auto D-Dimer Calibrator, Model A7971	Sigma Diagnostics, Inc.	DAP	Class II	2001-12-26
K013445	Osprey Spherical and Toric Multifocal Soft Contact Lenses	Florida Optical Engineering, Inc.	LPL	Class II	2001-12-26
K013225	Instaclot for OTC Use, Traumasstat for Prescription Use	Medafor, Inc.	KMF	Class I	2001-12-26
K012731	Solo-Care Plus Multipurpose Solution	Alcon Laboratories	LPN	Class II	2001-12-26
K011589	Corlink Aad (3.5 to 6.0 M M Outer Diameter Vessels),model 200-064, Corlink Aad (2.0 to 4.0 Mm Outer Diameter Vessels), M	Bypass, Ltd.	NCA	Class II	2001-12-26
K014099	Bioscanner Plus	Polymer Technology Systems	NBW	Class II	2001-12-21
K014058	Entegra Pe Personal Digital Assistant	General Electric Medical Systems	LLZ	Class II	2001-12-21
K013995	Modification to Mas Cardiolmmune Tl; Dade Cardiac Tl	Medical Analysis Systems, Inc.	JJY	Class I	2001-12-21
K013925	Sensititre Haemophilus/streptococcus Pneumoniae (Hp) Mic Susceptibility Plates	Trek Diagnostic Systems, Ltd.	JWY	Class II	2001-12-21
K013900	Vitros Immunodiagnostic Products Vitamin B12 Range Verifiers	Ortho-Clinical Diagnostics, Inc.	JJX	Class I	2001-12-21
K013850	Standard a, Standard B, Standard C, Cal, Slope	DIAMOND DIAGNOSTICS Inc	JIT	Class II	2001-12-21
K013817	Glo-Spec	Sol Weiss MD, Inc.	HIB	Class II	2001-12-21
K013800	Insyte, Angiocath, Insyte Autoguard, Angiocath Autoguard, Autoguard Pro, Intima, and Saf-T-Intima Intravascular Cathete	Becton Dickinson Infusion Therapy Systems Inc.	FOZ	Class II	2001-12-21
K013698	Ast (Sgot)	JAS Diagnostics/Drew Scientific	CIT	Class II	2001-12-21
K013652	Wiener Lab. Ca-Color Aa, Model 4 X 50 Ml Cat.n 1152002	Wiener Laboratories Saic	CIC	Class II	2001-12-21
K013628	Diamedix Is-Anti-B2 Glycoprotein I Igg/igm Test System	Diamedix Corp.	MSV	Class II	2001-12-21
K013606	Acs 180 Homocysteine Assay	Bayer Diagnostics Corp.	LPS	Class II	2001-12-21
K013568	Cea Assay for the Advia Integrated Modular System	Bayer Corp.	DHX	Class II	2001-12-21
K013527	Modification to Synthes (USA) Reamer Irrigator Aspirator (Ria) System	Synthes (USA) Products LLC	HTO	Class I	2001-12-21
K013482	Abuscreen Online Opiates 300 / 2000	Roche Diagnostics GmbH	DJG	Class II	2001-12-21