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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 427 of 3528

510(k) clearances, page 427 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K193547	CustomizedBone Service	Fin-Ceramica Faenza SpA	GXN	Class II	2020-01-17
K193543	CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System	In2bones USA, LLC	HRS	Class II	2020-01-17
K193509	AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX	Acutus Medical, Inc.	DYB	Class II	2020-01-17
K193507	Merit ONE Snare System	Merit Medical Systems, Inc.	MMX	Class II	2020-01-17
K193182	Evis Exera III Duodenovideoscope Olympus TJF-Q190V	Olympus Medical Systems Corp.	FDT	Class II	2020-01-17
K193007	LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module	LiNA Medical Inc	HIH	Class II	2020-01-17
K192926	RxSight Insertion Device	RxSight Inc.	MSS	Class I	2020-01-17
K192761	Asimov-MKS Imaging System	Onlume, Inc.	IZI	Class II	2020-01-17
K192635	Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)	WRP Asia Pacific Sdn Bhd	LZA	Class I	2020-01-17
K192606	SAC2 - Electrode Cream	Spes Medica S.P.A	GYB	Class II	2020-01-17
K192583	PicoLazer Laser System	Rohrer Aesthetics, Inc.	GEX	Class II	2020-01-17
K192563	Altera gas Sampling Lines	Meditera Tibbi Malzeme San ve Tic AS	CCK	Class II	2020-01-17
K192547	Maglumi 2000 Hcg/ß-Hcg	Shenzhen New Industries Biomedical Engineering Co.,Ltd	DHA	Class II	2020-01-17
K192495	Black Diamond Navigation Instruments	Osseus Fusion Systems LLC	OLO	Class II	2020-01-17
K192415	Study Watch with Irregular Pulse Monitor	Verily Life Sciences, LLC	DXH	Class II	2020-01-17
K192302	Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter	Medtronic, Inc.	MPB	Class II	2020-01-17
K192211	SoundBite Console, SoundBite Active Wire 18	Soundbite Medical Solution, Inc.	PDU	Class II	2020-01-17
K192182	C015	Micronica SRL	OWB	Class II	2020-01-17
K190871	Bio-TackS Orthodontic Mini Implant	Biocetec Co., Ltd.	OAT	Class II	2020-01-17
K190306	AMD Ritmed AssureWear VersaGown	AMD Medicom Inc.	FYC	Class II	2020-01-17
K181089	SureLead Cable System	Authentic Medical	DSA	Class II	2020-01-17
K193611	Viveve 2.0 System	Viveve Medical, Inc.	GEI	Class II	2020-01-16
K193500	Stellar M22 for Intense Pulsed Light (IPL) and Laser System	Lumenis Ltd	GEX	Class II	2020-01-16
K193488	GlideScope BFlex 3.8 Single-Use Bronchoscope	Verathon Medical (Canada) ULC	EOQ	Class II	2020-01-16
K192956	Auto Positioning	GE Hangwei Medical Systems, Co. Ltd	JAK	Class II	2020-01-16
K192942	ALLthread Titanium Suture Anchor	Zimmer GmbH	MBI	Class II	2020-01-16
K192869	SherpaPak Lung Preservation System , SherpaPak Liver Transport System	Pragonix Technologies	KDN	Class II	2020-01-16
K192750	AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip	Parcus Medical, L.L.C.	MBI	Class II	2020-01-16
K192357	Innovo	Atlantic Therapeutics, Ltd.	QAJ	Class II	2020-01-16
K191831	MobiliT Cup	Corin USA	LZO	Class II	2020-01-16
K191802	Electric Breast Pump	Ningbo Huiyoo Baby Products Co., Ltd.	HGX	Class II	2020-01-16
K191538	Resectr Tissue Resection Device	Boston Scientific Corporation	HIH	Class II	2020-01-16
K191095	Maxxi Snore Sensor	Neurovirtual USA, Inc.	MNR	Class II	2020-01-16
K193503	Arthrex SwiveLock Suture Anchor	Arthrex GmbH	MAI	Class II	2020-01-15
K193493	ADVIA Centaur Total IgE (tIgE)	Siemens Healthcare Diagnostics Inc.	DGC	Class II	2020-01-15
K193225	KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography	Konica Minolta, Inc.	KPR	Class II	2020-01-15
K192454	Wattson Temporary Pacing Guidewire	Vascular Solutions LLC	DQX	Class II	2020-01-15
K192251	Livento Press, Soprano 10, Soprano	Cendres+metaux SA	EIH	Class II	2020-01-15
K192004	Eko Analysis Software	Eko Devices, Inc.	MWI	Class II	2020-01-15
K191275	All’InCath 035M PTA Balloon Dilatation Catheter	Nexstep Medical	LIT	Class II	2020-01-15
K191266	VitalScan ANS	Medeia Inc	JOM	Class II	2020-01-15
K191125	Adas 3D	Galgo Medical S.L	LLZ	Class II	2020-01-15
K190981	NEX-D2 Posterior Fixation System	Next Orthosurgical	NKB	Class II	2020-01-15
K190028	Uno 30	Genadyne Biotechnologies, Inc.	OMP	Class II	2020-01-15
K183284	INTRAcel RF Microneedle System	Jeisys Medical Inc.	GEI	Class II	2020-01-15
K181005	ClenchGuard	Boyd Research	OBR	Unclassified	2020-01-15
K193478	XTRAC Momentum Excimer Laser System	Strata Skin Sciences, Inc.	GEX	Class II	2020-01-14
K193188	MiiS Horus Eye Anterior Camera	Medimaging Integrated Solution, Inc (Miis)	HJO	Class II	2020-01-14
K192920	Oragene®•Dx	DNA Genotek Inc.	OYJ	Class II	2020-01-14
K192800	Streamline TL Spinal Fixation System	Pioneer Surgical Technology, Inc. (dba Rti Surgical, Inc.)	NKB	Class II	2020-01-14