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 666 of 3530

510(k) clearances, page 666 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K151737	MedicVOD System	Orpheus Medical, Ltd.	LLZ	Class II	2016-02-25
K151508	IRENE Locking Compression Plate System	Tianjin Zhengtian Medical Instrument Co., Ltd.	HRS	Class II	2016-02-25
K151435	Mrcat	Philips Medical Systems MR Finland	MUJ	Class II	2016-02-25
K151406	Cogent Lateral Interbody System	Cogent Spine, LLC	MAX	Class II	2016-02-25
K160161	BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit	Becton Dickinson & Co	PSZ	Class II	2016-02-24
K153588	EndoChoice Water Bottle Cap System	Boston Scientific Corporation	FEQ	Class II	2016-02-24
K152768	Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip	Assure Tech LLC	JHI	Class II	2016-02-24
K152539	SpineView X-Pac Expandable Lumbar Cage System	Spine View, Inc.	MAX	Class II	2016-02-24
K152310	HeartLight Deflectable Sheath	CardioFocus, Inc.	DRA	Class II	2016-02-24
K152088	IV-eye	Novarix Limited	KZA	Class I	2016-02-24
K152085	Liquid CO2-2 (LCO2-2)	Randox Laboratories, Limited	KHS	Class II	2016-02-24
K151337	Strialite	Centre Light Solutions, LLC	OHS	Class II	2016-02-24
K150304	Oxyless Blood Tubing Set	Oxyless, Ltd.	FJK	Class II	2016-02-24
K160326	5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)	JVCKENWOOD Corporation	PGY	Class II	2016-02-23
K160247	2MP Color LCD Monitor, RadiForce RX250 and RX250-AR	Eizo Corporation	PGY	Class II	2016-02-23
K160198	UreTron MultiProbe Lithotripter System	Med-Sonics Corp.	FFK	Class II	2016-02-23
K160196	Fujifilm Video Colonoscope Model EC-600WL V2	FUJIFILM Healthcare Americas Corporation	FDF	Class II	2016-02-23
K153474	Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series	Biochemical Diagnostics Inc	DIF	Class I	2016-02-23
K153323	Palisade Pedicular Fixation System	Spineology, Inc.	NKB	Class II	2016-02-23
K152831	Spot Skan	Skanray Technologies Private Limited	DXN	Class II	2016-02-23
K152557	Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters	G21, S.r.l.	NDN	Class II	2016-02-23
K152160	Navik 3D	Apn Health, LLC	DQK	Class II	2016-02-23
K152034	Fs-Pacs	Ec-Web Co., Ltd.	LLZ	Class II	2016-02-23
K151717	twion	Alber GmbH	ITI	Class II	2016-02-23
K151092	Arthrex Short Suture Anchors	Arthrex GmbH	MBI	Class II	2016-02-23
K142969	ANI Monitor	Mdoloris Medical Systems SAS	DPS	Class II	2016-02-23
K153690	PriMatrix Dermal Repair Scaffold	Integra LifeSciences Braintree Inc.	KGN	Unclassified	2016-02-22
K153548	Vs3 Stereoscopic High Definition Vision System	Visionsense, Ltd.	HRX	Class II	2016-02-22
DEN150009	B.R.A.H.M.S PCT sensitive KRYPTOR	B.R.A.H.M.S GmbH	PMT	Class II	2016-02-20
K160315	I4 (Integrated Intelligent Imaging Informatics) system	Philips Medical Systems Nederland B.V.	LLZ	Class II	2016-02-19
K160096	InZone Detachment System	Stryker Corp.	HCG	Class II	2016-02-19
K153586	Arthrex iBalance TKA System	Arthrex GmbH	MBH	Class II	2016-02-19
K153384	Low Potassium Dextran Solution with Tris Diluent	United Therapeutics Corporation	KDN	Class II	2016-02-19
K153330	FreeStyle Precision Neo H Blood Glucose Monitoring System	Abbott Medical	NBW	Class II	2016-02-19
K153220	syngo.CT Single Source Dual Energy (Twin Beam)	Siemens Medical Solutions USA, Inc.	JAK	Class II	2016-02-19
K153215	SmartBase for Arthrex Glenoid IRIS	Custom Orthopaedic Solutions, Inc.	KWS	Class II	2016-02-19
K152922	ViziShot FLEX	Spiration, Inc.	KTI	Class II	2016-02-19
K152827	Weely Manual Wheelchair	Rupiani	IOR	Class I	2016-02-19
K152611	V20 system	Viora, Ltd.	GEX	Class II	2016-02-19
K152496	CPX 4 Breast Tissue Expander	Mentor Worldwide, LLC	LCJ	Unclassified	2016-02-19
K151793	InMode RF System	Inmode MD, Ltd.	GEI	Class II	2016-02-19
K151520	Oscar 2	Suntech Medical, Inc.	DXN	Class II	2016-02-19
K151480	Epix Electrosurgical Probe with Smoke Evacuation	Applied Medical Resources Corp	GEI	Class II	2016-02-19
K151439	Atlantis Isus	Dentsply International, Inc.	NHA	Class II	2016-02-19
K151423	APEX Compounding System Transfer Set	B.Braun Medical, Inc.	LHI	Class II	2016-02-19
K151263	Venturi Gauze Wound Care Sets with Portal Drain	Talley Group Ltd.	OMP	Class II	2016-02-19
K150492	Ora-GUARD Dental Grind Guard	Bite Tech, Inc.	OBR	Unclassified	2016-02-19
K160291	Optimus ALIF System	Spinal Elements, Inc	OVD	Class II	2016-02-18
K153442	CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems	Medtronic Sofamor Danek USA Inc	NKB	Class II	2016-02-18
K153395	OS2-C Compression Staple	In2Bones SAS	JDR	Class II	2016-02-18