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 2046 of 3531

510(k) clearances, page 2046 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K953571	Vasport Vascular Access Port	Gish Biomedical, Inc.	LJT	Class II	1995-10-02
K953474	IV Start Kit	Medikmark, Inc.	FPA	Class II	1995-10-02
K951187	Varelisa Cardiolipin ABS Screen	Elias U.S.A., Inc.	MID	Class II	1995-10-02
K950728	Quickvue One-Step Allergen Screen	Ortho-Clinical Diagnostics, Inc.	DHB	Class II	1995-10-02
K946136	Infinitech Lighted Infusion Cannula	Surgical Technologies, Inc.	MPA	Class II	1995-10-02
K954265	Trocar Style Needle/co-Axial Introducer Needle	Promex, Inc.	KNW	Class II	1995-09-29
K954223	American Dental Products Alginate Flavoring	American Dental Products, Inc.	ELW	Class II	1995-09-29
K954200	Voxgram	Voxel	IWZ	Class I	1995-09-29
K954199	Voxbox	Voxel	IXC	Class I	1995-09-29
K954198	Voxcam	Voxel	LMC	Class II	1995-09-29
K954059	Titan 20 Cc Driver	Halyard Health	MEB	Class II	1995-09-29
K954056	Universal Plus Es S/i Instrument	Conmedcorp	GEI	Class II	1995-09-29
K953953	Deroyal Industries, Inc. Pneumatic Tourniquet Cuff	DeRoyal Industries, Inc.	KCY	Class I	1995-09-29
K953868	Grasping Forceps, Biopsy Forceps, Scissors, Punch	Richard Wolf Medical Instruments Corp.	HRX	Class II	1995-09-29
K953659	Arthroscopic Electrosurgery System (Modification)	ArthroCare Corporation	HRX	Class II	1995-09-29
K953628	Prophy Angle	Rolence Enterprise Co., Ltd.	EHK	Class I	1995-09-29
K953574	Nezhat-Dorsey Hydro-Dissection Universal Bag Squeezer	American Hydro-Surgical Instruments, Inc.	HET	Class II	1995-09-29
K953497	Comfeel:alginate Dressing	MEDLINE INDUSTRIES, LP - Northfield	KMF	Class I	1995-09-29
K953446	Aesculap Bipolar Cords	Aesculap Inc	GEI	Class II	1995-09-29
K953417	Miniflex Model 340, 341, and 342 Pulse Generators	Cook Pacemaker Corp.	DXY	Class III	1995-09-29
K953410	Brimfield Precision Articulating Fan Retractor	Springfield Surgical Instruments	GCJ	Class II	1995-09-29
K953273	Bioplate Rigid Fixation Bone Plating System	Biomedics	JEY	Class II	1995-09-29
K953246	Octoroll	Octostop, Inc.	KXH	Class I	1995-09-29
K953241	Exspor	Alcide Corp.	LRJ	Class I	1995-09-29
K953221	Abbott Vision Hemoglobin (Modification)	Abbott Medical	KHG	Class II	1995-09-29
K953121	Microsurge Thoracoscopic Access System	Microsurge, Inc.	GCJ	Class II	1995-09-29
K952990	Spin Rollere	Kinsei Shiatsu, Inc.	ISA	Class I	1995-09-29
K952980	The Tulip Large Soft Tissue Retractor	The Tulip Mfg. Co.	GCJ	Class II	1995-09-29
K952935	The Tulip Small Soft Tissue Retractor	The Tulip Mfg. Co.	GCJ	Class II	1995-09-29
K952923	Intramedullary Compression Arthrodesis (Ica) Nail	Howmedica Corp.	HSB	Class II	1995-09-29
K952759	Towel Pack	Medcare Custom Packaging, Inc.	KKX	Class II	1995-09-29
K952743	Aspartate Aminotransferase Reagent System	Medical Diagnostic Technologies, Inc.	CIT	Class II	1995-09-29
K952738	Skin Saver Systems	Skin Saver Systems, Inc.	FQM	Class I	1995-09-29
K952728	Retrac	Centrix, Inc.	ELW	Class II	1995-09-29
K952328	Nanos, Pikos 01/E01, 01-a, E01-B, Lp 01/Lp E01	BIOTRONIK AG	DXY	Class III	1995-09-29
K951738	Argyle Neo-Sert Triple Lumen Umbilical Vessel Catheter	Sherwood Medical Co.	FOS	Class II	1995-09-29
K951557	Easterclave	Easter Services, Inc.	FLE	Class II	1995-09-29
K944542	Reusable All - Glass Syringes	Top Syringe Mfg. Co.	FMF	Class II	1995-09-29
K944444	Cit Biopsy Punches	Chirurgische Instrumente	HFB	Class I	1995-09-29
K943361	Northgate Flow Assist Tubing for Urology	Northgate Technologies Inc.	LJH	Class II	1995-09-29
K942139	Suprasson P Max	Satelec	ELC	Class II	1995-09-29
K940973	Mullan Ganglion Microcompression Set	Cook Inc.	HAO	Class I	1995-09-29
K940600	Stimulator, Nerve, Transcutaneous, (Pain Relief) 84-Gzj	Progressive Concepts, Inc.	GZJ	Class II	1995-09-29
K925681	Myotrac2d/cs	Thought Technology Ltd.	HIR	Class II	1995-09-29
K954067	3M Model 8295	3M Company	ESD	Class I	1995-09-28
K954054	Maico Prodigy Cic Series	Maico Hearing Instruments, Inc.	ESD	Class I	1995-09-28
K953952	Deroyal Industris, Inc. Blood Pressure Cuff	DeRoyal Industries, Inc.	DXQ	Class II	1995-09-28
K953675	Altadyne	Lumex, Inc.	FNM	Class II	1995-09-28
K953604	Shaping Hedstrom N.t.	Sybron Dental Specialties, Inc.	EKS	Class I	1995-09-28
K953385	Lorenz 1.0Mm, 1.5Mm, 2.0Mm System	Biomet Microfixation	JEY	Class II	1995-09-28