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 2043 of 3531

510(k) clearances, page 2043 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K951913	Oval Surgical Face Mask	Oval Industries, Ltd.	FXX	Class II	1995-10-12
K951858	Transvenous, Permanent Tined Target Tip Pacing Leads	Medtronic, Inc.	DTB	Class III	1995-10-12
K950854	Vitalograph 2110 Software Interface	Vitalograph, Inc.	DSH	Class II	1995-10-12
K945618	Gastrointestinal Tubes & Accessories	Applied Medical Technologies	KNT	Class II	1995-10-12
K945506	Acrylic Dipped Latex Examination Gloves	Ganz Industries Sdn. Bhd.	LYY	Class I	1995-10-12
K944993	Iolab.site Cd Phacoemulsification Module	Chiron Vision Corp.	HQC	Class II	1995-10-12
K941279	Lower Bowel Evacuation System	Tiller Mind Body, Inc.	KPL	Class II	1995-10-12
K954322	Tri-Point Liquimmune Liquid Assayed Immunoassay Control	Medical Analysis Systems, Inc.	DIF	Class I	1995-10-11
K953423	Casrrasyn Oral Wound Dressing	Carrington Laboratories, Inc.	OLR	Unclassified	1995-10-11
K952275	Global Medical Products Tuohy & Crawford Epidural Needle W/plastic Hub	Global Medical Prods, Inc.	BSP	Class II	1995-10-11
K950209	J.b.s. Anterior Spine System(r)	J.B.S. (USA), Inc.	KWQ	Class II	1995-10-11
K942431	Laporoscopic Scissors	Enterprise Medical Corp.	HET	Class II	1995-10-11
K954596	Pro-B Core-Rect Coaxial Biopsy System	Promedical, Ltd.	FCG	Class II	1995-10-07
K954528	Miracle - Ear Model Pbp	Miracle-Ear, Inc.	ESD	Class I	1995-10-07
K954516	Unitron Model Sound F/x II	Unitron Industries, Inc.	ESD	Class I	1995-10-07
K954404	Aurolite 45	Argen Precious Metals, Inc.	EJT	Class II	1995-10-07
K954371	Surefire S	Argen Precious Metals, Inc.	EJT	Class II	1995-10-07
K954368	Argedent Bio 87 Pf	Argen Precious Metals, Inc.	EJT	Class II	1995-10-07
K954367	Argistar Bio 75Pf	Argen Precious Metals, Inc.	EJT	Class II	1995-10-07
K954361	Argenco 68M	Argen Precious Metals, Inc.	EJT	Class II	1995-10-07
K954360	Argesol 600	Argen Precious Metals, Inc.	EJT	Class II	1995-10-07
K954359	Silfree 80Sf+	Argen Precious Metals, Inc.	EJT	Class II	1995-10-07
K954358	Argendent Gio 86 Fr	Argen Precious Metals, Inc.	EJT	Class II	1995-10-07
K954356	Compax 90/15E	General Electric Co.	IXR	Class II	1995-10-07
K954312	Active Thyroxine Ria	Diagnostic Systems Laboratories, Inc.	CDX	Class II	1995-10-07
K954255	Philips Tomoscan Sr 8000	Philips North America LLC	JAK	Class II	1995-10-07
K954121	Cytology Brush	Lighthouse Medical, Inc.	FDX	Class II	1995-10-07
K954074	Aalto Scientific Liquid Cardiac Control	Aalto Scientific Ltd.	JJY	Class I	1995-10-07
K953932	Unitron Model Sound F/xd	Unitron Industries, Inc.	ESD	Class I	1995-10-07
K953919	Dental Ultrasonic Scaler Inserts	HU-Friedy Mfg. Co. LLC	ELC	Class II	1995-10-07
K953888	Telescope 4Mm, 2.7Mm Diam. Wide Angle 0', 30', 70', 4Mm, Diam, 30' Work, L 14Cm, Autoclavable	Vista Medical Technologies, Inc.	EOB	Class II	1995-10-07
K953727	Unitron Model Ikon Aohpd	Unitron Industries, Inc.	ESD	Class I	1995-10-07
K953597	Noprofile Olbert Catheter System Balloon Dilation Catheter	Meadox Medicals, Div. Boston Scientific Corp.	EZN	Class II	1995-10-07
K953573	ICU Stopcok with Extension Tubing	Abbott Medical	FMG	Class II	1995-10-07
K953514	Courier II	Gammex, Inc.	LMD	Class I	1995-10-07
K953477	Modular Daylight Cassette for Video Imaging	The du Pont Co.	LMC	Class II	1995-10-07
K953475	Cds Compact Daylight Cassette for Video Imaging	The du Pont Co.	LMC	Class II	1995-10-07
K953422	Fox Fastidious Test Panels	Micro-Media Systems, Inc.	JWY	Class II	1995-10-07
K953418	Electrocautery Shroud	I.C. Medical, Inc.	GCJ	Class II	1995-10-07
K953332	Ms Classique Balloon Dilatation Cahteter	Meadox Medicals, Div. Boston Scientific Corp.	FGE	Class II	1995-10-07
K953290	Olympus Automatic Surgical Irrigation Pump	OLYMPUS Corporation of the Americas	KZD	Class I	1995-10-07
K953270	Model 1100 Medmate Infusion Pump	Patient Solutions, Inc.	FRN	Class II	1995-10-07
K952929	Ld General Purpose Disinfectant	Alcide Corp.	LRJ	Class I	1995-10-07
K952763	Panoramic X-Ray Unit (Modification)	Planmeca Oy	EHD	Class II	1995-10-07
K951764	Unidos Universal Dosimeter Model 10002-with Tnc Connector, 10005-with Bnt Connector	Ptw-New York Corp.	IYE	Class II	1995-10-07
K951700	Gore-Tex Soft Tissue Patch	W. L. Gore & Associates, Inc.	FTL	Class II	1995-10-07
K951676	Gore-Tex Dualmesh Biomaterial	W. L. Gore & Associates, Inc.	FTL	Class II	1995-10-07
K951675	Gore-Tex Mycromesh Biomaterial	W. L. Gore & Associates, Inc.	FTL	Class II	1995-10-07
K951254	Safetyglide Needle	BD Becton Dickinson Vacutainer Systems Preanalytic	FMI	Class II	1995-10-07
K951241	Haemophilus/pneumococcus Mic Plate	Radiometer America, Inc	JWY	Class II	1995-10-07