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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 750 of 3530

510(k) clearances, page 750 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K132592	Flexor Radial Hydrophilic Introducer Access Set	Cook Inc.	DYB	Class II	2014-10-09
K142515	MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra	Siemens Medical Solutions USA, Inc.	LNH	Class II	2014-10-08
K142198	BNX Fine Needle Aspiration System	Medtronic, Inc.	NEU	Class II	2014-10-08
K141855	Clarity	Elekta Limited	IYE	Class II	2014-10-08
K141456	The Fiagon Navigation - Extended Instrument Set ENT, Registrationpointer, Venterapointer, Guidewire, Pointershell	Fiagon GmbH	PGW	Class II	2014-10-08
K141378	Idc Interlocking Detachable Coil	Boston Scientific Corporation	KRD	Class II	2014-10-08
K141326	Needle View Ch Scope Kits	Biovision Technologies, LLC	HRX	Class II	2014-10-08
K141201	A&d Medical Ua-767F and Ua-767Fac Digital Blood Pressure Monitor	A&D Company, Ltd.	DXN	Class II	2014-10-08
K140249	Long Pulse Nd: Yag Laser System	Advanced Technology Laser Co., Ltd.	GEX	Class II	2014-10-08
K133245	Genesys Spine Anterior Cervical Plate II System	Genesys Spine	KWQ	Class II	2014-10-08
K131487	Fluor Protector S	Ivoclar Vivadent, Inc.	LBH	Class II	2014-10-08
K142353	First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test	WHPM Inc.	DIO	Class II	2014-10-07
K142275	Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens	Neo Vision Co., Ltd.	LPL	Class II	2014-10-07
K142027	888 Wnle Powered Wheelchair	Pihsiang Machinery Mfg. Co., Ltd.	ITI	Class II	2014-10-07
K141739	Residual Limb Lengthening System	Ellipse Technologies, Inc.	HSB	Class II	2014-10-07
K141699	Vassen Color	Vassen Co., Ltd.	LPL	Class II	2014-10-07
K141623	EMG Blue Nitrile Medical Examination Glove with Chemotherapy Drug Labeling Claim	Eco Medi Glove Sdn Bhd	LZA	Class I	2014-10-07
K141510	EMG White Nitrile Medical Examination Gloves (Powder Free)	Eco Medi Glove Sdn Bhd	LZA	Class I	2014-10-07
K141160	A&d Medical Ua-651 Digital Blood Pressure Monitor	A&D Company, Ltd.	DXN	Class II	2014-10-07
K140467	Flex-Mt +	Emsi	IPF	Class II	2014-10-07
K140304	Simply Slick Personal Lubricating Lotion	Simply Solutions, LLC	NUC	Class II	2014-10-07
K133040	LED Curing Light	Monitex Industrial Co., Ltd.	EBZ	Class II	2014-10-07
K142538	LiNA SafeAir Smoke Pencil	LiNA Medical Inc	GEI	Class II	2014-10-06
K141973	Diode Laser Hair Removal System	Beijing Anchorfree Technology Co Ltd	GEX	Class II	2014-10-06
K141894	Sharkcore Fine Needle Biopsy System	Covidien, LLC( Formerly Beacon Endoscopic Corp.)	FCG	Class II	2014-10-06
K141842	Starband, Starlight	Orthomerica Products, Inc.	MVA	Class II	2014-10-06
K141708	Ultrashape System	Syneron Medical, Ltd.	OHV	Class II	2014-10-06
K141704	Novashield Injectable Nasal Packing and Stent	Medtronic, Inc.	LYA	Class I	2014-10-06
K141522	Apex Medical Corp. Ich CPAP with Pva 9S-007Xxx Series	Apex Medical, Inc.	BZD	Class II	2014-10-06
K142540	24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244)	JVCKENWOOD Corporation	PGY	Class II	2014-10-03
K142536	21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220)	JVCKENWOOD Corporation	PGY	Class II	2014-10-03
K142534	HyProCure II	Graham Medical Technologies, L.L.C. d.b.a. GraMedica	HWC	Class II	2014-10-03
K142466	UGEO PT60A Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	IYN	Class II	2014-10-03
K142442	Magna-Fx and Mini Magna-Fx Cannulated Screw Fixation System	Zimmer GmbH	HWC	Class II	2014-10-03
K142304	Viberect Penile Vibratory Stimulation Device	Reflexonic, LLC	KXQ	Class II	2014-10-03
K141765	Fdr D-Evo Flat Panel Detector System	FUJIFILM Healthcare Americas Corporation	MQB	Class II	2014-10-03
K141743	Fusion Digital Diagnostic X-Ray Upgrade Kit	Radiology Solutions, LLC	MQB	Class II	2014-10-03
K141502	Hbp4 Hardening, Resorbable Hemostatic Bone Putty	Orthocon, Inc.	MTJ	Unclassified	2014-10-03
K141297	Forum Glaucoma Workplace	Carl Zeiss Meditec Inc	NFJ	Class II	2014-10-03
K141139	Solex Intravascular Heat Exchange Catheter	ZOLL Circulation, Inc.	NCX	Class II	2014-10-03
K140605	Minipegaso Cough, Minipegaso a-Cough, Minipegaso a-Coug Perc	Dima Italia SRL	NHJ	Class II	2014-10-03
K140309	Cranioplug	Ossdsign	GXR	Class II	2014-10-03
K140062	Fsc Anti-Static Valved Collapsible Holding Chamber	Fsc Laboratories, Inc.	NVP	Class II	2014-10-03
K133975	Msa100 Peak Flow Meter	Beijing M&B Electronic Instruments Co., Ltd.	BZH	Class II	2014-10-03
K142302	BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System	Polymer Technology Systems	CGA	Class II	2014-10-02
K142268	Varian Verification System (VVS)	Varian Medical Systems, Inc.	IYE	Class II	2014-10-02
K141664	Safe'n'sound Staked Passive Delivery System - Cone Version	Rexam Healthcare	MEG	Class II	2014-10-02
K141542	Nellcor Portable Spo2 Patient Monitoring System ( Npspms )	Medtronic, Inc.	DQA	Class II	2014-10-02
K141347	Emerge Medical Im Nail System	Emerge Medical	HSB	Class II	2014-10-02
K141200	Padi-Lock	Padi-Lock, LLC	FPA	Class II	2014-10-02