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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3374 of 3526

510(k) clearances, page 3374 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K792617	Tracheotomy Sponge, Non-Adherent Barrier	American Medical Disposable, Inc.	EFQ	Unclassified	1980-01-09
K792616	Tracheotomy Sponge, Non-Adherent W/hdpe	American Medical Disposable, Inc.	EFQ	Unclassified	1980-01-09
K792615	Cellulose Trache Sponge	American Medical Disposable, Inc.	EFQ	Unclassified	1980-01-09
K792614	Trachoetomy Sponge, Non-Adherent Cell	American Medical Disposable, Inc.	EFQ	Unclassified	1980-01-09
K792613	Tracheotomy Sponge, Non-Adherent	American Medical Disposable, Inc.	EFQ	Unclassified	1980-01-09
K792612	Tracheotomy Sponge, W/non-Woven Nylon	American Medical Disposable, Inc.	EFQ	Unclassified	1980-01-09
K792517	Kodak X-Omat Rp Film	Eastman Kodak Company	IWZ	Class I	1980-01-09
K792516	Respirator Disconnect Alarm Cr 201	Intersect Medical Products, Inc.	CAP	Class II	1980-01-09
K792515	Respirator Disconnect Alarm	Intersect Medical Products, Inc.	CAP	Class II	1980-01-09
K792464	Model 341H (Hearing Aid)	Telex Communications, Inc.	ESD	Class I	1980-01-09
K792463	Model 339 Telecros Wireless Cros	Telex Communications, Inc.	ESD	Class I	1980-01-09
K792462	Model 339 Telecros Wireless Bicros	Telex Communications, Inc.	ESD	Class I	1980-01-09
K792448	Kodak X-Omat G Film	Eastman Kodak Company	IWZ	Class I	1980-01-09
K792446	Adr Real-Time Sector Scanner	Adr Ultrasound	IYO	Class II	1980-01-09
K792437	Raflex 70	Mdt Corp., Inc.	EAP	Class II	1980-01-09
K792435	Kodak X-Omat M20 Processor, Model 1	Eastman Kodak Company	IWZ	Class I	1980-01-09
K792434	Kodak X-Omat M20 Processor, Model 2	Eastman Kodak Company	IWZ	Class I	1980-01-09
K792423	Todd Hewitt Broth	Isle Media and Sterile Products, Inc.	JSG	Class I	1980-01-09
K792363	Silagum	Parkell, Inc.	ELW	Class II	1980-01-09
K792354	The Circulator Boot	Circulator Boot Corp.	DRN	Class II	1980-01-09
K792317	Sr 301 Medical X-Ray Film	E.I. Dupont de Nemours & Co., Inc.	IWZ	Class I	1980-01-09
K792307	Dentix Dental X-Ray Unit	Precise Optics	EAP	Class II	1980-01-09
K792293	Kodak Ortho G Film	Eastman Kodak Company	IWZ	Class I	1980-01-09
K792178	Kodak Cfn Film So-224	Eastman Kodak Company	IWZ	Class I	1980-01-09
K791976	Dynasound 601	Dynawave, Corp.	IMI	Class II	1980-01-09
K791959	Post Extra Systolic Postentlator	Medrad, Inc.	IXO	Class I	1980-01-09
K792677	Database Management & Reporting System	Honeywell, Inc.	DQK	Class II	1980-01-04
K792653	Sentry	Automated Screening Devices	DXN	Class II	1980-01-04
K792608	Tegtmeier Mammometer	Aztec Medical Products, Inc.			1980-01-04
K792598	Disposable Incentive Spirometer	Hospitak, Inc.	BWF	Class II	1980-01-04
K792591	Stress Table/ergometer System	Victoreen, Inc.	ISD	Class II	1980-01-04
K792590	Ap-1 Auto Programmer	Burdick Corp.	IOL	Class I	1980-01-04
K792578	Epic Cannula	Dental Development Services, Inc.	EIC	Class I	1980-01-04
K792577	Endovage Syringe	Dental Development Services, Inc.	EIC	Class I	1980-01-04
K792569	Operating Tables & Amplinox 03	Ets Rene Marzet	BWN	Class I	1980-01-04
K792380	Cms 6000	Physio Control, Inc.	GYE	Class II	1980-01-04
K792245	Teeth, Denture, Plastic	Dentsply Intl.	ELM	Class II	1980-01-04
K792213	Renal Systems Hemodialysis Concentrate	Renal Systems, Inc.	KPO	Class II	1980-01-04
K791868	Oximetrix Shaw Hemostatic Surg. Sys.	Oximetrix, Inc.	GEI	Class II	1980-01-04
K792639	H-H Shunt Introducer	Holter-Hausner Intl.	GYK	Class I	1979-12-31
K792604	Lifeline Tle Endocardial Pacing Lead,	Intermedics, Inc.	DTB	Class III	1979-12-31
K792601	Lifelift Models One and Two	Corda Int'L Holiday, Inc.	FSA	Class I	1979-12-31
K792596	Tryptic Soy Agar W/phenylethanol &	Isle Media and Sterile Products, Inc.	JSJ	Class I	1979-12-31
K792595	Sf Medium (Sf Broth, Streptococcus	Isle Media and Sterile Products, Inc.	JSJ	Class I	1979-12-31
K792594	Tryptic Soy Agar W/lecithin & Polysrbte.	Isle Media and Sterile Products, Inc.	JSG	Class I	1979-12-31
K792593	Phenylethanol Agar	Isle Media and Sterile Products, Inc.	JSJ	Class I	1979-12-31
K792586	Halo Support Jacket & Assoc. Hardware	Depuy, Inc.	HAX	Class II	1979-12-31
K792584	Aca Ethosurimide Test Pack	E.I. Dupont de Nemours & Co., Inc.	DLF	Class II	1979-12-31
K792573	Alarm Used W/monitoring Spirometer	Empire Plastics Manufacturer	BZK	Class II	1979-12-31
K792570	Patient Trolley B49	Ets Rene Marzet	FPO	Class II	1979-12-31