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 2026-10-22, 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 2939 of 3529

510(k) clearances, page 2939 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K853941	Int'l Model Xg Behind-the-Ear Hearing Aid	Int'L Hearing Aids, Inc.	ESD	Class I	1985-12-18
K853919	Ma25 Portable Audiometer	Maico Hearing Instruments, Inc.	EWO	Class II	1985-12-18
K853863	Model 310 Impedance System	Virtual Corp.	ETY	Class II	1985-12-18
K853711	5.0 Mhz Intracavitary Sector Probe	General Electric Co.	HEM	Class II	1985-12-18
K853667	Bronchial Cytology Brush	E-Z-EM, Inc			1985-12-18
K853588	Fibrelight Nasal Specula	Downs Surgical, Ltd.	EPY	Class I	1985-12-18
K852630	Den-Mat Paint-on Rubber Dam	Den-Mat Corp.	EIE	Class I	1985-12-18
K854759	American Sterile Mayo Stand Tray	American Hospital Supply			1985-12-17
K854752	The California Splint	Intl. Medication Systems, Ltd.	DXQ	Class II	1985-12-17
K854746	Surgical Instrument Tray	Zbi, Inc.	FSM	Class I	1985-12-17
K854714	X-Ray Detectable Cotton Balls	American Silk Sutures, Inc.	GDY	Class I	1985-12-17
K854620	Surgical Blades	Niraj Industries	GES	Class I	1985-12-17
K854592	Malis Micro Bipolar Coagulator	Valley Forge Scientific Corp.	GEI	Class II	1985-12-17
K854579	Hypodermic Needle and Stylet	Berkley and Co.	GAA	Class I	1985-12-17
K854541	Tip Off Forceps	Keller Instruments, Inc.	GEN	Class I	1985-12-17
K854148	Battle Creek Digi-Tracker Elctric Treadmill	Battle Creek Equipment	IOL	Class I	1985-12-17
K854140	Modified Mydriatic Spectacle	La Rue Optical			1985-12-17
K853142	Ovutime Ovulation Predictor Test	Advanced Care Products	CEP	Class I	1985-12-17
K851962	Zimmon Biliary Stent Set	Wilson-Cook Medical Inc.	FGE	Class II	1985-12-17
K851954	Pvl-4.8-200 Balloon Stone Extractor	Wilson-Cook Medical Inc.	FGE	Class II	1985-12-17
K854479	Bedside Console Ha-57P/blood & Heparin Pump Bip-Bh	Nipro Company, Ltd.	FKP	Class II	1985-12-16
K854440	Modified Clinical Widefield Specular Microscope 50	Keeler Instruments, Inc.	HRM	Class I	1985-12-16
K854367	Hd-Secura Hemadialysis Machine	bioMerieux, Inc.	FKP	Class II	1985-12-16
K854314	Fana 60	American Bio-Reagents, Inc.	DHN	Class II	1985-12-16
K854253	Root Canal Filling Resin	Dentsply Intl.	KIF	Class II	1985-12-16
K854169	Pupilscan	Fairville Medical Optics, Inc.			1985-12-16
K854045	Membrane Oxygenating Sys Adult Bmos-7 & Bmos-3 Ped	American Bentley	DTZ	Class II	1985-12-16
K853811	Hard Contact Lens Soaking Solution	Maurry Biological Co.	HPX	Unclassified	1985-12-16
K853810	Wetting Solution for Hard Contact Lenses	Maurry Biological Co.	HPX	Unclassified	1985-12-16
K853807	All-in-One Hard Contact Lens Solution	Maurry Biological Co.	HPX	Unclassified	1985-12-16
K853697	Biostar Re-a-Ds Immune Complex Assay Kit	Biostar Medical Products, Inc.	DAK	Class II	1985-12-16
K853430	Storz Ias Disposable Pack	Storz Instrument Co.	HQE	Class II	1985-12-16
K852365	Link Shoulder Prosthesis Endo-Model System	Link America, Inc.	KWS	Class II	1985-12-16
K851864	Spinal Stabilizing Unit	Counterstress Products, Inc.			1985-12-16
K854776	Everest & Jennings Bed Model No. L109564 & L108564	Carrom Healthcare, Inc.	FNJ	Class I	1985-12-13
K854724	Cekk-Adhesive Matrix-Multiple Well Plate Cam-Plate	Lifetrac, Inc.	KIZ	Class I	1985-12-13
K854651	Paraamax Chloride Determination by Ise	American Dade	CGJ	Class I	1985-12-13
K854650	Dsl Active Androstenedione Ria (Dsl #3800)	Diagnostic Systems Laboratories, Inc.	CIZ	Class I	1985-12-13
K854649	Dsl Progesterone Ria (Dsl #3400)	Diagnostic Systems Laboratories, Inc.	JLS	Class I	1985-12-13
K854586	Hollow Fiber Dialyzer	Travenol Laboratories, S.A.	KDI	Class II	1985-12-13
K854580	Conveen Self-Sealing Urisheath Male External Cath	MEDLINE INDUSTRIES, LP - Northfield	KNX	Class II	1985-12-13
K854544	Raichem CO2 Reagent	Reagents Applications, Inc.	KHS	Class II	1985-12-13
K854330	Is-2000 Digital Ophthalmic Imaging System	Par Technology Park	HKI	Class II	1985-12-13
K854309	Gambro Blood Concentrator Sets 16,60,200	Gambro, Inc.	KDI	Class II	1985-12-13
K854280	Clirans Taf Hollow Fiber Dialyzer	Terumo Medical Corp.	FJI	Class II	1985-12-13
K854256	Keeler Amoils Surgical Astigometer	Keeler Instruments, Inc.			1985-12-13
K854158	Resnick Emitter, Artificial Larynx	Dynamed Audio, Inc.	ESE	Class I	1985-12-13
K854047	In-Home Vision Monitoring Kit	Rich-Larky Company, Inc.	HOX	Class I	1985-12-13
K853961	Visitec Ophthalmic Aspiration Unit Model 100	Visitec Co.	HQE	Class II	1985-12-13
K853940	The Groningen Voice Prosthesis	Hood Laboratories	EWL	Class II	1985-12-13