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 1474 of 3531

510(k) clearances, page 1474 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K023189	Vista Basic with Fm System	B.Braun Medical, Inc.	FRN	Class II	2003-03-20
K023162	Fresenius Punctur-Guard Fistula Needle Sets	Fresenius Medical Care	FIE	Class II	2003-03-20
K022947	Advanced Perfusion System 1 (100/120 Volt),advanced Perfusion System 1 (220/240 Volt, Roller Pumps (6, 4 Inch	Terumo Cardiovascular Systems Corporation	DTQ	Class II	2003-03-20
K030621	Atac Calibrator	Elan Diagnostics	JIX	Class II	2003-03-19
K030552	Imageless Knee Module for the Stealthstation System	Medtronic Navigation, Inc	HAW	Class II	2003-03-19
K030482	Wiener Lab. Standatrol S-E 2 Niveles, Lovels 1&2: 3X5 Ml Vials Cat.nr.1937553	Wiener Laboratories	JJY	Class I	2003-03-19
K030287	Hemosil Factor XI Deficient Plasma	Instrumentation Laboratory Co.	GJT	Class II	2003-03-19
K030057	Spectral Cardiac Status Ck-Mb/myoglobin/troponin I 3-in-1 Test	Spectral Diagnostics, Inc.	MMI	Class II	2003-03-19
K023990	Chromocheck Protein C 25; Chromocheck Protein C 50	Precision BioLogic Inc.	GGP	Class II	2003-03-19
K023090	Option-Vf Urinary Catheter, Fv14218	Opticon Medical, Inc.	EZL	Class II	2003-03-19
K030626	Vitros Chemistry Products Crp Slide and Calibrator Kit 7	Ortho-Clinical Diagnostics, Inc.	DCK	Class II	2003-03-18
K030140	Duomed, Series 500, (Models Id 500, Fl 500)	Duomed, Inc.	GZJ	Class II	2003-03-18
K030096	Video Arthroscope, Models Ar-3050-30, Ar-3050T-30, Ar-3050-70, Ar-3051-30, Ar-3052-30, Ar3030an, Ar-3030As, Ar3030aw	Arthrex GmbH	HRX	Class II	2003-03-18
K030005	Vanguard Reprocessed Diagnostic Electrophysiology Catheter Accessory Cables	Stryker Sustainability Solutions	DSA	Class II	2003-03-18
K024305	Wiener Lab. Calibrator a Plus, Model 2X3 Ml Cat. Nr. 1918006	Wiener Laboratories Saic	JIX	Class II	2003-03-18
K024251	Sightfix	World of Medicine Lemke GmbH	GCJ	Class II	2003-03-18
K023954	Altus Medical Coolglide Laser Systems and Accessories	Altus Medical, Inc.	GEX	Class II	2003-03-18
K023472	Low Profile EEG Needle Electrode, Models 112-812-18Tp, 112-812-48Tp, 112-812-60Tp, 112-812-72Tp, 112-812-96Tp, 112-812	Class A Enterprises, Inc.	GXZ	Class II	2003-03-18
K023237	Xylos Surgical Mesh	Xylos Corporation	FTM	Class II	2003-03-18
K022627	Dsg Relaxer Splint	Sentage Corporation D/B/A/ Dental Services Group	MQC	Unclassified	2003-03-18
K022096	Uric Acid Assay for the Advia Integrated Modular System	Bayer Diagnostics Corp.	KNK	Class I	2003-03-18
K013936	Silverleaf Contact Wound Dressing	Silverleaf Technologies, Inc.	FRO	Unclassified	2003-03-18
K030628	Sas Rsv Control Kit	SA Scientific, Ltd	JJX	Class I	2003-03-17
K030609	Moduleaf	Mrc Systems GmbH	IXI	Class II	2003-03-17
K030503	Modification to Contour Polaris Ureteral Stent	Boston Scientific Corporation	FAD	Class II	2003-03-17
K030438	Bard Aquaguide Ureteral Conduit	C.R. Bard Inc	FED	Class II	2003-03-17
K030227	Suturtek Fastclose Suturing Device	Suturtek Incorporated	GAL	Class II	2003-03-17
K030161	Superbond	American Dent-All, Inc.	EJH	Class II	2003-03-17
K024364	Synthes Vertebral Spacer Ti (Curved and Narrow)	Synthes (USA) Products LLC	MQP	Class II	2003-03-17
K024357	Sensititre 18-24 Hour Susceptibility Plates	Trek Diagnostic Systems, Ltd.	LTT	Class II	2003-03-17
K024235	Dolphin Medical Stand-Alone Pulse Oximeter	Dolphin Medical, Inc.	DQA	Class II	2003-03-17
K024190	Fenestrated Infusion Catheter	Promedic, Inc.	FRN	Class II	2003-03-17
K024183	Alton Pt Stepper	Alton Design, LLC	KXK	Class II	2003-03-17
K024160	Neosporin Scar Solution	Warner-Lambert Co.	MDA	Class I	2003-03-17
K023694	Bio-Mark Resorbable Biopsy Site Marker and Bio-Mark Permanent Biopsy Site Marker	Biopsy Sciences, LLC	NEU	Class II	2003-03-17
K030679	Mas Lipid Level 1 and 2	Medical Analysis Systems, Inc.	JJY	Class I	2003-03-14
K030532	Cpca2000 Counterpulsation System	Cpca2000, Inc.	DRN	Class II	2003-03-14
K030475	Gdc Stretch Resistant Detachable Coil	Boston Scientific Corporation	HCG	Class II	2003-03-14
K030467	Gravitech Tm Flow Controller Primary Set/gravitech Flow Controller Extension Set	Iv Medical, Inc.	FPA	Class II	2003-03-14
K030464	Gem, Model 004110	Collins Medical, Inc.	BZG	Class II	2003-03-14
K030228	Powderfree Polychloroprene Sterilized Surgical Gloves	PT. Medisafe Technologies	KGO	Class I	2003-03-14
K030077	Gish Tubing and Connectors with Gbs Coating	Gish Biomedical, Inc.	DTL	Class II	2003-03-14
K024275	Auto Suture Premium Plus Ceea Disposable Stapler	United States Surgical, A Division of Tyco Healthc	GDW	Class II	2003-03-14
K024199	Immix Thin Film, Models: Pss-004-S, Pss-004-Sp, Pss-004-M, Pss-004-Mp, Pss-004-L, Pss-004-Lp	Osteobiologics, Inc.	FTL	Class II	2003-03-14
K024180	Oramagicrx Oral Wound Rinse	MPM Medical	OLR	Unclassified	2003-03-14
K024124	System 100-Uf 500 Circuit with in-Line Needleless Access Port	Chf Solutions, Inc.	KDI	Class II	2003-03-14
K030566	Linical Protein 3 Calibration Verifiers Levels a-E for the Olympus Au Series Chemistry Immuno Analyzers	Cliniqa Corporation	JJY	Class I	2003-03-13
K030455	Boris Platform Diagnostic Ultrasound System	Philips North America LLC	IYN	Class II	2003-03-13
K030350	Express Mini Glaucoma Shunt	Optonol, Ltd	KYF	Class II	2003-03-13
K024115	Microfix Quickanchor Plus	Mitek Worldwide	HWC	Class II	2003-03-13