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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 655 of 3529

510(k) clearances, page 655 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K152553	CueSee Hypoxic	Eurotrol B.V.	JJS	Class I	2016-04-22
K151357	Miri Tl	At Medical UAB	MQG	Class II	2016-04-22
K160827	Pantheris Catheter	Avinger, Inc.	MCW	Class II	2016-04-21
K160249	ULTRA Telescopes	Olympus Winter & Ibe GmbH	HRX	Class II	2016-04-21
K160206	VirtuoSaph Plus Endoscopic Vessel Harvesting System	Terumo Cardiovascular Systems Corporation	GEI	Class II	2016-04-21
K160172	Laparoscope Lens Shield Device	Medeon Biodesign, Inc.	GCJ	Class II	2016-04-21
K160142	Mineral Oil	Kitazato Biopharma Co., Ltd.	MQL	Class II	2016-04-21
K153614	PROBEAT-V and accessories	Hitachi, Ltd., Health Care Company	LHN	Class II	2016-04-21
K153558	Ventix Suture Anchor	Biomet Manufacturing Corp	MBI	Class II	2016-04-21
K153404	Zavation Spinal System	Zavation	MNH	Class II	2016-04-21
K152365	AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System	Agamatrix	NBW	Class II	2016-04-21
K152222	NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs	GMP Medicare Sdn Bhd(F25)	LZC	Class I	2016-04-21
K152117	Dropper hsCRP High Sensitivity CRP Control	Quantimetrix Corp.	JJX	Class I	2016-04-21
K152077	MaxiGen	Hans Biomed Corp.	MQV	Class II	2016-04-21
K152059	Disposable General Electrode	Modern Medical Equipment Manufacturing Ltd.	GEI	Class II	2016-04-21
K150914	Dash-Topic Plus Cream	Founders Science Group, LLC	FRO	Unclassified	2016-04-21
K160832	Penumbra Smart Coil	Penumbra Inc.	HCG	Class II	2016-04-20
K160500	Elite SPK, Compasso, Elite SPK Kit	NCS Lab SRL	MBI	Class II	2016-04-20
K160440	Leksell Gamma Knife Icon	Elekta Instrument AB	IWB	Class II	2016-04-20
K160051	NuVasive® Interfixated Interbody System	Nu Vasive, Incorporated	OVD	Class II	2016-04-20
DEN140022	Glaucoma Companion	Innovatex, Inc.	PLX	Class I	2016-04-20
K160674	Fujifilm Sonosite Vevo MD Imaging System	FUJIFILM SonoSite,Inc.	IYN	Class II	2016-04-19
K160126	AIRO Computed Tomography (CT) X-ray System	Brainlab, Inc.	JAK	Class II	2016-04-19
K153698	LumenR Tissue Retractor System	Lumenr, LLC	ODB	Class II	2016-04-19
K153694	Icare ic100	Icare Finland Oy	HKY	Class II	2016-04-19
K153648	Microcyn Plus Skin and Wound Hydrogel	Sonoma Pharmaceuticals, Inc.	FRO	Unclassified	2016-04-19
K153638	Bicortical Fixation Screw & Washer Nut System	First Ray, LLC	HWC	Class II	2016-04-19
K153194	VASOVIEW HemoPro Endoscopic Vessel Harvesting System	Maquet Cardiovascular LLC	GEI	Class II	2016-04-19
K151527	Arthrex Univers Revers CA Heads and Adapters	Arthrex GmbH	HSD	Class II	2016-04-19
K153192	Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests	Chemtron Biotech, Inc.	DJG	Class II	2016-04-18
K152563	Pulse Oximeter (MD300M/MD300K2)	Beijing Choice Electronic Technology Co., Ltd.	DQA	Class II	2016-04-18
K160792	Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound	The Prometheus Group	IYO	Class II	2016-04-15
K160788	RIOScan (RPS500)	Ray Co., Ltd.	MUH	Class II	2016-04-15
K160749	CRIT-LINE III Blood Chamber II	Fresenius Medical Care Renal Therapies Group, LLC	KOC	Class II	2016-04-15
K160195	Forma System, Forma Light System	Formatk Systems Ltd.	ONF	Class II	2016-04-15
K153655	Accuryn Monitoring System	Potrero Medical, Inc.	EZL	Class II	2016-04-15
K153624	Neodent Implant System	Jjgc Industria E Comercio de Materiais Dentarios S	NHA	Class II	2016-04-15
K153501	Bullfrog Micro-Infusion Device	Mercator Medsystems, Inc.	KRA	Class II	2016-04-15
K153361	Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators	Fujirebio Diagnostics, Inc.	MRG	Class II	2016-04-15
K153343	MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit	Siemens Medi Cal Solutions, Inc.	LNH	Class II	2016-04-15
K153222	Leva Spacer System	Spine Wave Inc	MAX	Class II	2016-04-15
K152590	ACCU NEWS Drug Screening Test Card/Urine Cup	Coretests, Inc.	DKZ	Class II	2016-04-15
K152075	VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)	bioMerieux, Inc.	LON	Class II	2016-04-15
K151922	StimSox(TM) System	Stimmed, LLC	IPF	Class II	2016-04-15
K151874	BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal	Salter Labs	MNR	Class II	2016-04-15
K151855	SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber	Surgical Laser Incorporated	GEX	Class II	2016-04-15
K151731	Rainbow Paste Stain	GENOSS Co., Ltd.	EIH	Class II	2016-04-15
K151120	Simple T Pediatric Nasal Mask	Respironics, Inc.	BZD	Class II	2016-04-15
K150476	Spectra S1Plus and Spectra S2 Plus	Uzinmedicare Co., Ltd.	HGX	Class II	2016-04-15
K150372	VERASENSE Knee System	Orthosensor, Inc.	ONN	Class II	2016-04-15