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 2007 of 3531

510(k) clearances, page 2007 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K951592	Betatrans I and II	Duxbury Scientific, Inc.	CAC	Class II	1996-03-04
K945627	Pikos Lp 01, Pikos Lp E01	BIOTRONIK AG	DXY	Class III	1996-03-04
K960494	Euroline A312 Series of Behind the Ear Air Conduction Hearing Aids	Starkey Laboratories, Inc.	ESD	Class I	1996-03-01
K960404	Sureskin Thin	Euromed, Inc.	MGP	Unclassified	1996-03-01
K960394	Sureskin Standard	Euromed, Inc.	MGP	Unclassified	1996-03-01
K960393	Sureskin Border	Euromed, Inc.	MGP	Unclassified	1996-03-01
K960342	Pos-T-Vac Avp-1000 & Mvp-700	Pos-T-Vac, LLC	LKY	Class II	1996-03-01
K960170	Electroencephalograph (EEG)	Moberg Medical, Inc.	GWF	Class II	1996-03-01
K960028	Orthoralix Sd2 & S Panoramic Dental X-Ray System	Dentsply Intl.	EAP	Class II	1996-03-01
K955930	Beltone Composer 2000 Bte Hp	Beltone Electronics Corp.	ESD	Class I	1996-03-01
K955862	Full Spectrum Ule-Overclad Fiber: Model 201	Full Spectrum, Inc.	GEX	Class II	1996-03-01
K955764	Valley Forge Biploar Loop	Valley Forge Scientific Corp.	GEI	Class II	1996-03-01
K955708	Compumed Dicon Client	Compumed, Inc.	LMD	Class I	1996-03-01
K955643	Alara Imaging System	Denoptix, Inc.	EGY	Class II	1996-03-01
K955630	RNA Medical Hemat Control	Bionostics, Inc.	JJR	Class I	1996-03-01
K955283	Primus Variant System Pvs99	Trinity Biotech (Primus Corporation dba Trinity Biotech)	GKA	Class II	1996-03-01
K954527	Rockwell Medical Supply Llc Hemodialysis Concentrate Solutions & Powders	Rockwell Medical Supply	KPO	Class II	1996-03-01
K953819	Diagnostic Ultrasound Tranducer	Biosound, Inc.	ITX	Class II	1996-03-01
K953759	Diagnostic Ultrasound Transducer	Biosound, Inc.	ITX	Class II	1996-03-01
K953228	Narkomed Av2+ Anesthesia Ventilator	Draeger, Inc.	CBK	Class II	1996-03-01
K950537	Cardiophonics Incorporated Dps 2000 Phonocardiograph	Cardiophonics, Inc.	DQC	Class I	1996-03-01
K945782	Humidifier	Respironics, Inc.	BTT	Class II	1996-03-01
K960566	Nhmc Foley Catheterization Tray	National Healthcare Mfg. Corp.	FCM	Class II	1996-02-29
K960060	Dsl Active Prolactin Irma	Diagnostic Systems Laboratories, Inc.	CFT	Class I	1996-02-29
K955925	Cbc-Cal Plus Hematology Calibrator	R & D Systems, Inc.	KRX	Class II	1996-02-29
K955826	Gibson Id-M. Cat.	Microbiologics, Inc.	JTO	Class I	1996-02-29
K955796	Iron Calibrator & Calibration Verification Set	Data Medical Associates, Inc.	JJX	Class I	1996-02-29
K955738	Bioclot Protein S	Medical Diagnostic Technologies, Inc.	GGP	Class II	1996-02-29
K955558	Gip/medi-Globe Sclerotherapy Needles	Medi-Globe GmbH	FBK	Class II	1996-02-29
K955486	Bio-Anchor	Linvatec Corporation	MAI	Class II	1996-02-29
K955351	Neuroview Coaxial Bipolar Electrode	Neuro Navigational Corp.	GWG	Class II	1996-02-29
K955302	Serum Bicarbonate/carbon Dioxide	Data Medical Associates, Inc.	KHS	Class II	1996-02-29
K955298	Phoenix Dialysate Meter	Automata Medical Instrumentation, Inc.	FIZ	Class II	1996-02-29
K955266	Accustat Hcg Serum Diluent Reagent or Event Serum Diluent	Boehringer Mannheim Italia SpA	JHI	Class II	1996-02-29
K954718	Ellman Needle Extender/measured Dose Syringe	Ellman Intl., Inc.	HEE	Class II	1996-02-29
K954688	Flow-Count Coulter Fluorospheres	Coulter Corp.	GKZ	Class II	1996-02-29
K954380	Quanta Lite Ssdna	Inova Diagnostics, Inc.	LJM	Class II	1996-02-29
K954183	Ovulation Calculator/conception Calculator	Hector Vides	MPT	Class II	1996-02-29
K953568	Codman Fiducial Marker System	Cerenovus, Inc.	HAW	Class II	1996-02-29
K953546	Manual Pulmonary Resusicitator	Medical Marketing Concepts	BTM	Class II	1996-02-29
K953349	Spiracle Technoloty Gaseous Oxygen Supply Valve	Spiracle Technology	CBP	Class II	1996-02-29
K953127	Accustress Exercise Testing System	Hewlett-Packard Co.	DQK	Class II	1996-02-29
K952262	Speedband	Boston Scientific Corporation	FHN	Class II	1996-02-29
K952126	Aalto Scientific Liquid Cerebrospinal Fluid Controls Levels I and II	Aalto Scientific Ltd.	GGP	Class II	1996-02-29
K950018	Cambridge Heart Ch 2000 Stress Test System	Cambridge Heart, Inc.	DPS	Class II	1996-02-29
K942073	Sharpspro-Tector	Superior Diapering Products, Ltd.	FMI	Class II	1996-02-29
K960405	Spinal Needle	Promex, Inc.	MIA	Class II	1996-02-28
K955664	Sterilized Tri Block Polymer Gel Sheet	Silipos, Inc.	MDA	Class I	1996-02-28
K955551	Cardi0metrics Flow Wire Xt Doppler Guide Model 1403, 1404	Cardio Metrics, Inc.	DQX	Class II	1996-02-28
K955499	Lmi Bilumen Irrigation Arterial Embolectomy Cahteter	Lucas Medical, Inc.	MJN	Class II	1996-02-28