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 1937 of 3531

510(k) clearances, page 1937 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K963910	Heart Nebulizer #100609	Vortran Medical Technology 1, Inc	CAF	Class II	1996-12-16
K963884	Somnus Disposable Multiple Electrode Coagulating Probe Model 350	Somnus Medical Technologies, Inc.	GEI	Class II	1996-12-16
K963747	Reach Stim-U-Dent Plaque Removers with Microdent/reach Floss Stiks with Microdent/reach Floss Pics with Microdent Etc.	Whitehill Manufacturing, Inc.	JET	Class I	1996-12-16
K963633	Ventnet; Central Monitoring Station	Medtronic, Inc.	MOD	Class II	1996-12-16
K963539	Sigma Diagnostics Wash Concentrate	Sigma Diagnostics, Inc.	JJE	Class I	1996-12-16
K963297	Incstar Toxoplasma Igg Fast Elisa Assay (Cat.#7560)	Incstar Corp.	LGD	Class II	1996-12-16
K963296	Incstar Toxoplasma Igg Alisa Assay (Cat.#7565)	Incstar Corp.	LGD	Class II	1996-12-16
K963127	Elecsys Ft3	Boehringer Mannheim Corp.	CDP	Class II	1996-12-16
K963094	Cynosure Photogenica Lp Dermatological Vascular Lesion Laser	Cynosure, LLC	GEX	Class II	1996-12-16
K962917	Multidex Hydrophilic Wound Dressing Gel	Lange Medical Products, Inc.	MGQ	Unclassified	1996-12-16
K962641	Maxima Forte Hollow Fiber Oxygenator with Plasma Resistant Fiber	Medtronic, Inc.	DTZ	Class II	1996-12-16
K962296	Streptolex-Stat	Unipath, Ltd.	GTZ	Class I	1996-12-16
K962283	EEG Electrodes	Teca, Inc.	GXY	Class II	1996-12-16
K962230	Celsite Port with Preconnected Catheter	B.Braun Medical, Inc.	LJT	Class II	1996-12-16
K962050	Theratest El-Rfscr	Theratest Laboratories, Inc.	DHR	Class II	1996-12-16
K961859	Novus Standard and Pediatric Valves	Integra Neurocare, LLC	JXG	Class II	1996-12-16
K960643	Advantage Mapf Hip Femoral Component	Zimmer GmbH	KWY	Class II	1996-12-16
K960101	Island Biosurgical Bolster	Island Biosurgical, Inc.	OTN	Class II	1996-12-16
K954610	Model 430-07 Endocardial Pacing Lead	Intermedics, Inc.	DTB	Class III	1996-12-16
K964749	Coverage HBV	Convatec, A Division of E.R. Squibb & Sons	LRJ	Class I	1996-12-13
K964640	Cantrol Iron/tibc Controls, Level 1 and Level 2 Product Numbers: Level 1: Iibc-91 and Level 2: Iibc-92	Canyon Diagnostics, Inc.	JJY	Class I	1996-12-13
K964613	Virex II 256 Germicidal Cleaner and Deodorant	S.C. Johnson & Son, Inc.	LRJ	Class I	1996-12-13
K964610	Triad II Disinfectant Cleaner and Deodorant	S.C. Johnson & Son, Inc.	LRJ	Class I	1996-12-13
K964535	Virex Tb Ready-to-Use Dsinfectant Cleaner & Deodorant	S.C. Johnson & Son, Inc.	LRJ	Class I	1996-12-13
K964418	N-Assay Tia Rheumatoid Facotr Multi-Calibrator Set	Kamiya Technology Services	DHR	Class II	1996-12-13
K964415	N-Assay Tia Rheumatoid Factor Test Kit	Kamiya Technology Services	DHR	Class II	1996-12-13
K964355	Ontrak Testcup 5 (Modification)	Roche Diagnostic Systems, Inc.	LCM	Unclassified	1996-12-13
K964328	Synthes (USA) Synthes Mmfs-Adjustable Sagittal Split Plate	Synthes (USA) Products LLC	JEY	Class II	1996-12-13
K964173	C-Mount Objective Lens F = 17 Mm, Steam-Sterilizable: Model 85 261.172, C-Mount Objective Lens F = 21 Mm, Steam-Steriliz	Richard Wolf Medical Instruments Corp.	FET	Class II	1996-12-13
K964158	Jel-40 (Code Name Rd-0430)	Jelenko Co.	EJT	Class II	1996-12-13
K964068	Carbamazepine Assay for the Technicon Immuno 1 System	Bayer Corp.	KLT	Class II	1996-12-13
K963849	Manan D Bag	Argon Medical Devices, Inc	EXF	Class II	1996-12-13
K963733	Niccheck I	Dynagen, Inc.	MRS	Class I	1996-12-13
K963707	Nellcor Puritan Bennett Npb-40 Handheld Pulse(npb-40)	Medtronic, Inc.	DQA	Class II	1996-12-13
K963062	Immage System Digoxin (Dig) Reagent/beckman Drug Calibrator 2	Beckman Instruments, Inc.	KXT	Class II	1996-12-13
K962968	Proc Apc Assay, Proc Control Plasma	Behring Diagnostics, Inc.	GGP	Class II	1996-12-13
K962212	Karl Storz Frimberger Varioguide	Karl Storz Endoscopy-America, Inc.	FDT	Class II	1996-12-13
K961687	Evita 4	Drager, Inc.	CBK	Class II	1996-12-13
K964683	Digifocus Ite	Oticon, Inc.	ESD	Class I	1996-12-12
K964429	Sunglasses or Multiple	Trade Resources, Ltd.	HQY	Class I	1996-12-12
K964241	Brennen Medical Glucan II Wound Dressing	Brennen Medical, Inc.	MGQ	Unclassified	1996-12-12
K964123	Reusable Trocar with Sleeve (Common)	Pilling Weck Group	GCJ	Class II	1996-12-12
K964071	Oratec Interventions Model Ora 50 Electrothermal Generator	Oratec Interventions, Inc.	GEI	Class II	1996-12-12
K963988	Intravascular Infusion Device	Boston Scientific Corporation	KRA	Class II	1996-12-12
K963979	Ultradent Universal Dentin Sealant	Ultradent Products Inc.	LBH	Class II	1996-12-12
K963963	Multiset Software for Automated Flow Cytometric Data Analysis	Becton Dickinson Immunocytometry Systems	GKZ	Class II	1996-12-12
K963839	Cordis Suction Reservoir - Model Number: 910-500	Cordis US Corp.	GCY	Class I	1996-12-12
K963824	Li's Itch Stopper	Hontech Foundation for Medical Technology	IRT	Class II	1996-12-12
K963806	Clampless Valved Catheter - Tunneled (Cvc-T)	Bmw Medical, Inc.	LJS	Class II	1996-12-12
K963802	Shunt Tap	Integra Neurocare, LLC	JXG	Class II	1996-12-12