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 1845 of 3531

510(k) clearances, page 1845 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K974394	Enoxacin Antimicrobial Susceptibility Test Disc	Oxoid, Ltd.	JTN	Class II	1998-01-14
K973963	120 Leaf Multileaf Collimator	Mitsubishi Electronics America, Inc.	IYE	Class II	1998-01-14
K973960	Model 37-185	Victoreen, Inc.	LHN	Class II	1998-01-14
K973953	Aktina Medical Physics Corporation Eectron Beam Field Shaping System	Aktina Medical Physics Corp.	IXI	Class II	1998-01-14
K974644	Vitros Immunodiagnostic Products Range Verifiers	Johnson & Johnson Clinical Diagnostics, Inc.	JJX	Class I	1998-01-13
K974527	Kht Seoam Needle, Hand Acupuncture Needle	American Institute of Koryo Hand Therapy	MQX	Class II	1998-01-13
K974304	Germicidal Cloth	Convatec, A Division of E.R. Squibb & Sons	LRJ	Class I	1998-01-13
K974083	Connecta Plus 1 and Connecta Plus 3 2-Way and 3-Way Stopcocks	GE Healthcare	FMG	Class II	1998-01-13
K973923	Ebi Spinelink Anterior Cervical Spinal System	Ebi Electro Biology	KWQ	Class II	1998-01-13
K973918	Nihon Kohden Bsm-1101 and Bsm-1102 Patient Monitor and Accessories	Nihon Kohden America Inc	DRT	Class II	1998-01-13
K973547	Triage Statmeter	Biosite Incorporated	KHO	Class I	1998-01-13
K973497	Huberloc	Medcare Medical Group, Inc.	LJT	Class II	1998-01-13
K972572	Single Lumen Embolectomy Catheter	American Biomed, Inc.	DXE	Class II	1998-01-13
K972535	Maglife C	Odam	MHX	Class II	1998-01-13
K971627	Silicone Antibacterial Foley Catheter	Rochester Medical Corp.	MJC	Class II	1998-01-13
K971076	Primed Shoe Covers, Primed Head Covers	Primeline Medical Products, Inc.	FXP	Class I	1998-01-13
K970922	Jobst Athrombic Pump/sleeve	Jobst A Beiersdorf Co.	JOW	Class II	1998-01-13
K974592	Interceptre Laparoscopic Instruments	Smith & Nephew, Inc.	GCJ	Class II	1998-01-12
K974511	Sunglasses	Sun World Intl., Inc.	HQY	Class I	1998-01-12
K974434	Osteonics Series 7000 Total Knee Anterior Femoral Blocks	Osteonics Corp.	HRY	Class II	1998-01-12
K974294	Encore Linear Porous Coated Hip	Encore Orthopedics, Inc.	LPH	Class II	1998-01-12
K974232	Essential Shaver System	Gyrus Ent LLC	EQJ	Class I	1998-01-12
K974058	Fs IV Mini C-Arm System	Hologic, Inc.	JAA	Class II	1998-01-12
K974039	Schwartz Electro-Optics, Inc. Clr 2940 Erbium Crystalase	Schwartz Electro-Optics, Inc.	GEX	Class II	1998-01-12
K974022	Vapr	Mitek Products	GEI	Class II	1998-01-12
K973982	Orbital Reconstruction Plates	Howmedica Corp.	HRS	Class II	1998-01-12
K973945	Luge Guide Wire	Scimed Life Systems, Inc.	DQX	Class II	1998-01-12
K973921	Bausch & Lomb2 Sensitive Eyes Multi-Purpose Solution	Bausch & Lomb Incorporated	LPN	Class II	1998-01-12
K973891	Laparoscopic Gastrostomy Kit	Applied Medical Resources Corp	KNT	Class II	1998-01-12
K973880	Sonix Hearing Aid Fitting and Programming System	Sonix Technologies, Inc.	ESD	Class I	1998-01-12
K973543	Kronner Low Profile Scope Holder	Kronner Prototypes, Inc.	GCJ	Class II	1998-01-12
K973132	Ez Hold 1 Lbs., Ez Hold 2 Lbs	TZ Medical Inc.	DXC	Class II	1998-01-12
K972791	Encore Linear Hip	Encore Orthopedics, Inc.	JDI	Class II	1998-01-12
K971116	Sonos 5500 Imaging System	Hewlett-Packard Co.	ITX	Class II	1998-01-12
K970663	CT Celluloser Triacetate Hollow Fiber Dialyzer (CT-110G/ct-190G)	Baxter Healthcare Corporation	MSF	Class II	1998-01-11
K980004	Manan General Purpose Introducer Needle	Medical Device Technologies, Inc.	KNW	Class II	1998-01-09
K974815	Manan(tm) Introducer Sheath/needle	Medical Device Technologies, Inc.	FGE	Class II	1998-01-09
K974814	Manan(tm) Super-Core Biopsy Needles	Medical Device Technologies, Inc.	KNW	Class II	1998-01-09
K974605	Randox Inorganic Phosphorous	Randox Laboratories, Limited	CEO	Class I	1998-01-09
K974589	Smartvalve	Abbott Medical	FPA	Class II	1998-01-09
K974569	Coaguchek System, Coaguchek System for Prothrombin Time Self Testing	Boehringer Mannheim Corp.	JPA	Class II	1998-01-09
K974470	Vtu-E Vacuum Erection System	Encore, Inc.	LKY	Class II	1998-01-09
K974441	Sunglasses	Hip Shing Fat Co., Ltd.	HQY	Class I	1998-01-09
K974334	Disposable Powder Free Vinyl Synthetic Examination Gloves	Hong Huang Tang Industrial Co., Ltd.	LYZ	Class I	1998-01-09
K974327	Winged Needle Holder	Phx Technologies Corp.	FHQ	Class I	1998-01-09
K974105	Kerr Compomer	Sybron Dental Specialties, Inc.	EBF	Class II	1998-01-09
K974088	Codman Intracranial Bolt	Johnson & Johnson Professionals, Inc.	GWM	Class II	1998-01-09
K973917	Cadd-Diplomat Pc Communications System and the Cadd- Ambassador Pump Communications System	Sims Deltec, Inc.	FRN	Class II	1998-01-09
K973884	Elastic Mandibular Advancement - Titration (Ema-T) Appilance	Frantz Design, Inc.	LRK	Class II	1998-01-09
K973584	Medtronic Instent Esophacoil Esophageal Stent System and Esophacoil Extension System	Medtech Instruments	ESW	Class II	1998-01-09