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 2354 of 3531

510(k) clearances, page 2354 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K921878	Scanmate III	Circadian, Inc.	IYP	Class I	1992-09-11
K921813	Med-TENS	Ems Dist.	GZJ	Class II	1992-09-11
K921504	Reusable Dual Disc Bar Electrodes, Various Models	Chalgren Enterprises, Inc.	JXE	Class II	1992-09-11
K921313	Aerostar	Biosafety Systems, Inc.	CBN	Class II	1992-09-11
K921143	Pneumo-Wedge	Kansas Creative Devices, Inc.	FQO	Class I	1992-09-11
K920469	Myocardinal Temperature Sensor with Type 400 Serie	Respiratory Support Products, Inc.	FLL	Class II	1992-09-11
K920390	The Peak	Multispiro, Inc.	BZH	Class II	1992-09-11
K920297	Disposable Scissors	Falcon Instruments, Inc.	MDM	Class I	1992-09-11
K920296	Disposable Forceps	Falcon Instruments, Inc.	MDM	Class I	1992-09-11
K915676	Splatter Shield	Chathamborough Research Group, Inc.	FMF	Class II	1992-09-11
K915188	Model P in-Line Bipolar Endocardial Tined Lead	Cook Pacemaker Corp.	DTB	Class III	1992-09-11
K915060	Astech Home Peak Flow Meter	Biotrine Corp.	BZH	Class II	1992-09-11
K911435	Cpa/3.5 Mhz Probe	Diasonics, Inc.	ITX	Class II	1992-09-11
K923986	Cybernetic Option (Cyber I)	Qualitone	ESD	Class I	1992-09-10
K923918	In-the-Ear Hearing Aid	Benway-Haworth-Lawlor Hearing Aids, Inc.	ESD	Class I	1992-09-10
K923345	Biad New Detector Option	Trionix Research Laboratory, Inc.	KPS	Class II	1992-09-10
K923151	Cardiac Triad New Detector Option	Trionix Research Laboratory, Inc.	KPS	Class II	1992-09-10
K923061	Mammoscan	Fischer Imaging Corp.	IZH	Class II	1992-09-10
K922734	Axiom Total Knee System and Plus Total Knee System	Orthomet, Inc.	JWH	Class II	1992-09-10
K921976	First Aid Kit	The Home Emergency Room	LYY	Class I	1992-09-10
K921130	Mrx-865	Mrx-Ray Tube Corp.	ITY	Class I	1992-09-10
K920090	Blom-Singer Tracheoesophageal Puncture Set	Freudenberg Medical, LLC	EWL	Class II	1992-09-10
K914424	Model 6213 Remote Alarm	Aequitron Medical, Inc.	CBK	Class II	1992-09-10
K914364	Astotherm Ift 250, Ift 260, Astotube Various No.	North American Technical Services Corp.	LGZ	Class II	1992-09-10
K923689	Surgistar Blades	Surgistar, Inc.	GDX	Class I	1992-09-09
K923679	Endopath Tissue Retaining Component	Ethicon Endo-Surgery Inc	KCJ	Class I	1992-09-09
K923677	Amylase Test	Em Diagnostic Systems, Inc.	JFJ	Class II	1992-09-09
K923404	Luekoflex Surgical Tape	Beiersdorf, Inc.	KGX	Class I	1992-09-09
K923328	Veneer Cement	Dentsply Intl.	EMA	Class II	1992-09-09
K923267	Systemate Total Protein Test, Technicon Ra 1000	Em Diagnostic Systems, Inc.	CEK	Class II	1992-09-09
K923203	Systemate Creatinine Test	Em Diagnostic Systems, Inc.	CGX	Class II	1992-09-09
K923186	Nexus Wheelchair Cushion/formerly Biothotic	ROHO, Inc.	KNN	Class I	1992-09-09
K923128	King Diagnostics Cholesterol Reagent	King Diagnostics, Inc.	CHH	Class I	1992-09-09
K923123	Hcg Pregnancy One Step Test Strip	Tcpi, Inc.	JHI	Class II	1992-09-09
K923091	King Diagnostics Gamma Gt Reagent	King Diagnostics, Inc.	JPZ	Class I	1992-09-09
K923083	Total Bilirubin Catalog No. 65407	Em Diagnostic Systems, Inc.	CIG	Class II	1992-09-09
K923036	Urine Chloride	Kulzer GmbH	CHJ	Class II	1992-09-09
K923035	Miles Urine Urea Nitrogen Method	Kulzer GmbH	CDQ	Class II	1992-09-09
K923020	Cleanic	Hawe Neos Dental	EJR	Class I	1992-09-09
K922953	Systemate Calcium Test Technicon Ra 1000	Em Diagnostic Systems, Inc.	CIL	Class II	1992-09-09
K922857	Systamate Aspartate Aminotransferase Test Technico	Em Diagnostic Systems, Inc.	CIT	Class II	1992-09-09
K922856	Systemate Direct Bilirubin Test Technicon Ra 1000	Em Diagnostic Systems, Inc.	CIG	Class II	1992-09-09
K922701	Du Pont Aca Plus Immunoassay System Tsh Method	E.I. Dupont de Nemours & Co., Inc.	JLW	Class II	1992-09-09
K922698	Du Pont Aca Plus Immunoassay System Tsh Calibrator	E.I. Dupont de Nemours & Co., Inc.	JIS	Class II	1992-09-09
K922473	Turn Ez Bed Device	Med-Ez, Inc.	IKZ	Class II	1992-09-09
K921611	Madavac 190	Mada Medical Products, Inc.	BTA	Class II	1992-09-09
K921602	Ultradent Product Tooth Surface Drying Agent	Ultradent Products Inc.	EBF	Class II	1992-09-09
K921598	Ultradent Product Pit & Fissure Sealant Prod Line	Ultradent Products Inc.	EBF	Class II	1992-09-09
K921409	Enamel and Porcelain Etch Product Line	Ultradent Products Inc.	EBF	Class II	1992-09-09
K921407	Composite and Porcelain Polishing Paste Prod. Line	Ultradent Products Inc.	EBF	Class II	1992-09-09