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 2335 of 3531

510(k) clearances, page 2335 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K923200	Amcath Disposable Cytology Brush	Intl. Medical, Inc.	FDX	Class II	1992-12-07
K922974	Portable Patient Monitor	Hewlett-Packard Co.	MHX	Class II	1992-12-07
K922565	Neoplastine(r) Ci Kit	American Bioproducts Co.	GJS	Class II	1992-12-07
K922432	Cholerascreen	New Horizons Diagnostics Co.	GSQ	Class II	1992-12-07
K922201	Coamate Protein C Chromogenic Assay	Chromogenix AB	GGP	Class II	1992-12-07
K922148	Argyle Aero-Jet Suction Catheter	Sherwood Medical Co.	BSY	Class I	1992-12-07
K922112	Easyflow	Epm Information Systems, Inc.	BZQ	Class II	1992-12-07
K920845	Vigil II	Beckman Instruments, Inc.	DCK	Class II	1992-12-07
K920699	Remstar Wtih Ramp and Remote Modification	Respironics, Inc.	BZD	Class II	1992-12-07
K920235	Ultrasound Generator Modle 2270	Richard Wolf Medical Instruments Corp.	FEO	Class II	1992-12-07
K915320	Rheuma-Lex(tm) Syst: Rheumatoid Factor Latex Test	Trinity Laboratories, Inc.	DHR	Class II	1992-12-07
K924478	Mtv-250A, Mtv-300A	Toshiba America Medical Systems, In.C	LMA	Class II	1992-12-04
K923901	Latex Examination Gloves	Medi Tex, Inc.	LYY	Class I	1992-12-04
K923838	The Ultimate Rcs Arch Wire	Ultimate Wireforms, Inc.	DZC	Class I	1992-12-04
K923556	Adp Facemask	Ormco Corp.	DZB	Class II	1992-12-04
K923227	Throat-a-Scope	Truphatek, Ltd.	EQH	Class I	1992-12-04
K922774	Collegiate	J.F. Jelenko & Co., Inc.	EJT	Class II	1992-12-04
K922537	Duralife	Dhd Diemolding Healthcare Div.	BZA	Class I	1992-12-04
K922147	Dual Plastic Vascular Access System	Gerard Medical Enterprises, Inc.	LJT	Class II	1992-12-04
K921809	Companion 800 Portable Nebulizer Compressor (C800)	Medtronic, Inc.	CAF	Class II	1992-12-04
K921776	1840 Ha Particles	Bio-Interfaces, Inc.	LYC	Class II	1992-12-04
K914276	Sime Health Sime Powderfree Examination Gloves	Sime Health, Ltd.	LYY	Class I	1992-12-04
K925435	Quickvue One-Step Hcg Test	Ortho-Clinical Diagnostics, Inc.	JHI	Class II	1992-12-03
K925249	Cmi Stoma Covers	Community Medical Center	BTO	Class II	1992-12-03
K925169	Shimadzu Radiograpjhic Stand Br-100	Shimadzu Medical Systems	KPX	Class II	1992-12-03
K925060	Remel Enoxacin 10 Mcg Susceptibility Disk	Remel Inc	JTN	Class II	1992-12-03
K925003	Cobas-Fp Reagent for Valproic Acid and Calibrators	Roche Diagnostic Systems, Inc.	LEG	Class II	1992-12-03
K924964	Olympus Total Bilirubin Reagent	Olympus Corp.	CIG	Class II	1992-12-03
K924758	Dmi Blood Gas Analyzer/cartridge	Diamond Medical, Inc.	CHL	Class II	1992-12-03
K924711	Bicarbonate	Em Diagnostic Systems, Inc.	KHS	Class II	1992-12-03
K924601	Olympus Glucose Reagent	Olympus Corp.	CFR	Class II	1992-12-03
K924586	Captus 500 Well Detector W/clinical Labor Software	Capintec Instruments, Inc.	IZD	Class I	1992-12-03
K924498	Maxxus	GE Healthcare	KPS	Class II	1992-12-03
K924428	Synermed Enzymatic CO2 Reagent Kit	Synermed, Inc.	KHS	Class II	1992-12-03
K923684	Api Uniscept Mic/type 2 and 3 and Micro Mic	Analytical Products, Inc.	JWY	Class II	1992-12-03
K923544	One Touch Test Strips	Lifescan, Inc.	CGA	Class II	1992-12-03
K923509	Gamma-Gt	Randox Laboratories, Limited	JPZ	Class I	1992-12-03
K923507	Alkaline Phosphatase Kit	Randox Laboratories, Limited	CJE	Class II	1992-12-03
K923410	Fiagen Progesterone	Cyberfluor, Inc.	JLS	Class I	1992-12-03
K923269	Convex and Linear Array Transducers	Aloka Co., Ltd.	IYO	Class II	1992-12-03
K923261	Orthodontic Metal Bracket	American Orthodontics	EJF	Class I	1992-12-03
K923136	Male External Catheter	Rochester Medical Corp.	EXJ	Class I	1992-12-03
K923043	Spectral EEG Monitor Model A1000	Aspect Medical Systems, Inc.	OLT	Class II	1992-12-03
K922790	Degucast 40	Degussa AG	EJH	Class II	1992-12-03
K922484	Cobe Sampling Site	LivaNova USA, Inc.	DQO	Class II	1992-12-03
K922113	Kendall Curity Continuous Epiddual Anesthesia Cath	Kendall Healthcare Products Co. Div.Of Tyco Health	BSO	Class II	1992-12-03
K921254	Blue Max II Balloon Ddilatation Catheter	Boston Scientific Corporation	LIT	Class II	1992-12-03
K921022	Disposable Curette	Dermtec, Inc.	MDM	Class I	1992-12-03
K920266	TENS Model 240Z	Oms Medical Supplies, Inc.	GZJ	Class II	1992-12-03
K915736	Medtronic Models 5069 and 5071 Myocardial Pacing	Medtronic, Inc.	DTB	Class III	1992-12-03