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 2026-10-21, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 3021 of 3529

510(k) clearances, page 3021 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K843484	Mecon X (Ten)	Mecon Labs	ESD	Class I	1985-01-23
K843370	Imsi/metripond Gripper Plate	Intl. Management Services, Inc.	HRS	Class II	1985-01-23
K843246	Hearing Aid, Unitron Ue12-Ppl	Unitron Industries, Inc.	ESD	Class I	1985-01-23
K842705	Mx2 Electronic Stethoscope	Medmax, Inc.	DQD	Class II	1985-01-23
K850070	Healthcheck Auto Inflate Digital Bp Monitor Bp-2	Healthcheck Corp.	DXN	Class II	1985-01-22
K844898	Canon 60 Zoom Fundus Camera Cf-60Za Ophthalmic Cam	Canon Medical Components U.S.A., Inc.	HKI	Class II	1985-01-22
K844851	Minimed External Infusion Pump for Diagetics 504	Pacesetter Systems	FRN	Class II	1985-01-22
K844792	Minimed External Infusion Pump for Diabetics 502A	Pacesetter Systems	FRN	Class II	1985-01-22
K844748	Nephross Allegro h.f.	bioMerieux, Inc.	FKQ	Class II	1985-01-22
K844715	Visc-X Vitreous Aspirating & Cutting Instrument Sy	Optical Micro Systems, Inc.	HQE	Class II	1985-01-22
K844694	Titmus Vision Tester II	Titmus Optical, Inc.	HIT	Class I	1985-01-22
K844650	Dr-2C	General Devices	DXJ	Class II	1985-01-22
K844500	Titertek Microplate Washer 120	Flow Laboratories, Inc.	JTC	Class I	1985-01-22
K844313	Infuset W/huber Needle	Med Fusion Systems, Inc.	FMI	Class II	1985-01-22
K844309	IV Ratemeter	Aci Medical, LLC	FLN	Class II	1985-01-22
K844227	Infusart	Sartorius, Inc.	FLN	Class II	1985-01-22
K844132	Medivision Series 5000 Fluoroscopic Digital Imager	Sigma Teleproducts, Inc.	LMB	Class I	1985-01-22
K850060	Du Pont Gentamicin Assay Reagents	E.I. Dupont de Nemours & Co., Inc.	LCD	Class II	1985-01-18
K850059	Du Pont Gentamicin Assay Calibrator	E.I. Dupont de Nemours & Co., Inc.	DLJ	Class II	1985-01-18
K850058	Du Pont Tobramycin Assay Reagents	E.I. Dupont de Nemours & Co., Inc.	LCR	Class II	1985-01-18
K850057	Du Pont Tobramycin Assay Calibrator	E.I. Dupont de Nemours & Co., Inc.	DLJ	Class II	1985-01-18
K845027	Kodak Ektachem Clinical Chemistry Slides	Eastman Kodak Company	CHI	Class I	1985-01-18
K845024	Baker Ckmb Reagent Set	Hybritech, Inc.	JHY	Class II	1985-01-18
K844998	Glucose(hexokinase) Reagent Set	Sterling Biochemical, Inc.	CFR	Class II	1985-01-18
K844987	Roche Reagents Reagent for CO2	Roche Diagnostic Systems, Inc.	KHS	Class II	1985-01-18
K844986	Roche Reagents Reagent for Uric Acid	Roche Diagnostic Systems, Inc.	CDO	Class I	1985-01-18
K844982	Vas-Cath Continous Epidural Anesth. Cath/kit/tray	Vas-Cath of Canada, Ltd.	CAZ	Class II	1985-01-18
K844962	Emit Qst Acetaminophen Assay	Syva Co.	LDP	Class II	1985-01-18
K844946	Emit Amitriptyline/nortriptyline Control	Syva Co.	DIF	Class I	1985-01-18
K844945	Emit Imipramine/desipramine Control	Syva Co.	DIF	Class I	1985-01-18
K844938	United Skin Barriers	Pfizer Inc	EXB	Class I	1985-01-18
K844911	Arrhythmia Central-Ogp-7201	Nihon Kohden America Inc	DRT	Class II	1985-01-18
K844907	Clinifacts 10 Data Management System	Miles Laboratories, Inc.	JQP	Class I	1985-01-18
K844786	Nurses & Surgeons Caps, Isolation Gowns-Fire Retar	Durawear	FYC	Class II	1985-01-18
K844759	Surgical Scalpel Blades & Disposables	Cross Country Paper Products Corp.	GES	Class I	1985-01-18
K844692	Pediatric Sized Hemocath Catheter	Quinton, Inc.	FIQ	Class II	1985-01-18
K844663	Asahi New Pan-Series Hemofilters	Asahi Kasei Medical MT Corp. Oita Works	KDI	Class II	1985-01-18
K844587	Avl Model 982 Electrolyte Analyzer	Avl Scientific Corp.	JGS	Class II	1985-01-18
K844572	Pre-Klene Enamel Cleaner	Medical Products Laboratories, Inc.	EFT	Class I	1985-01-18
K844559	Model 1020 Na+/k+(sodium/potassium)analyzer Multi	Thermo Orion	JGS	Class II	1985-01-18
K844511	Tdx Total Estriol	Abbott Medical	CGI	Class I	1985-01-18
K844504	Sartorius Minisart Sm 16596Hy	Sartorius Filters, Inc.	KOC	Class II	1985-01-18
K844341	United Skin Barrier Paste	Howmedica Corp.	EZR	Class I	1985-01-18
K844216	Grass Model Nl Facial Nerve Locator & Monitor	Grass Instrument Co.	JXE	Class II	1985-01-18
K844179	Lp-5	Life Products, Inc.	CBK	Class II	1985-01-18
K844103	Cardiopac Defibrillator 444	Birtcher Corp.	LDD	Class II	1985-01-18
K844066	Cotropin Stimulataneous 57 Co-Lh 125I I-Fsh	Clinetics Corp.	CGJ	Class I	1985-01-18
K844062	Forceps & Hamostats	I M, Inc.	GEN	Class I	1985-01-18
K844051	Skilcraft - Tracheotomy Care Kit 3 Compartment	Washington-Greene County Branch Pennsylvania Assoc	NXA	Class II	1985-01-18
K843797	Sterile Saline Solution	Paco Pharmaceutical Services, Inc.	BSY	Class I	1985-01-18