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 2026-10-21, 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 514 of 3529

510(k) clearances, page 514 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K181741	IceSphere 1.5 CX Cryoablation Needle	Galil Medical Ltd.	GEH	Class II	2018-07-30
K181736	CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,	Centers for Disease Control and Prevention (CDC)	OZE	Class II	2018-07-30
K181720	Epiphany Cardio Server Mobile	Epiphany Healthcare, LLC	DQK	Class II	2018-07-30
K181440	Proficient® Posterior Cervical Spine System	Spine Wave Inc	NKG	Class II	2018-07-30
K181431	Laser Ureteral Catheter	Cook Incorporated	GEX	Class II	2018-07-30
K181213	ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control	Siemens Healthcare Diagnostics Inc.	LFZ	Class II	2018-07-30
K180912	TE7/TE5 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2018-07-30
K172273	308nm Excimer System	Chongqing Peninsula Medical Technology Co., Ltd.	FTC	Class II	2018-07-30
K181763	FUJIFILM Ultrasonic Endoscope	FUJIFILM Corporation	FDS	Class II	2018-07-27
K181694	FlowTriever Retrieval/Aspiration System	Inari Medical, Inc.	QEW	Class II	2018-07-27
K181554	Stowe Pedicle Screw System	Black Box Medical	NKB	Class II	2018-07-27
K181485	EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System	Philips North America LLC	IYN	Class II	2018-07-27
K181452	Rct800	Ray Co., Ltd.	OAS	Class II	2018-07-27
K181395	Universal Cannula Seal (5-12 mm)	Intuitive Surgical, Inc.	GCJ	Class II	2018-07-27
K181184	OIC Intramedullary Nail System	The Orthopaedic Implant Company	HSB	Class II	2018-07-27
K181156	Panther Fusion GBS Assay	DIAGENODE S.A.	NJR	Class I	2018-07-27
K180627	Macroduct Advanced Model 3710	ELITechGroup Inc	KTB	Class II	2018-07-27
K180580	Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices	Medline ReNewal	KTT	Class II	2018-07-27
K180556	Corelink Foundation 3D Anterior Lumbar System	Corelink, LLC	MAX	Class II	2018-07-27
K180485	Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender	Medtronic, Inc.	FJS	Class II	2018-07-27
K180076	Ti 3Z Interbody System	Zavation Medical Products, LLC	MAX	Class II	2018-07-27
K180064	OsteoFab Patient Specific Cranial Device	Oxford Performance Materials, Inc.	GXN	Class II	2018-07-27
K173808	Voutia™	Jeffrey Ward Cash, Dds	LFD	Unclassified	2018-07-27
K173474	RetiCapture	Ilooda Co,., Ltd.	HKI	Class II	2018-07-27
K172616	Pulse Oximeter	Beijing Safe Heart Technology, Ltd.	DQA	Class II	2018-07-27
K181855	RadialSeal Introducer Kit	Great Batch Medical	DYB	Class II	2018-07-26
K181790	CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup	Hangzhou Clongene Biotech Co., Ltd.	NGL	Class II	2018-07-26
K181712	San Antonio Stopcock	Cook Incorporated	ODC	Class II	2018-07-26
K181706	neuromate Gen III	Renishaw Mayfield SARL	HAW	Class II	2018-07-26
K181699	Level 1 Convective Warmer	Abbott Medical	DWJ	Class II	2018-07-26
K181659	Avologi ENEO	Premier North America, Inc	OHS	Class II	2018-07-26
K181579	eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K	E&E Optics, Inc.	HQD	Class II	2018-07-26
K181401	RxSight Insertion Device	RxSight Inc.	MSS	Class I	2018-07-26
K181268	PROLENE (Polypropylene) 3D Patch	Ethicon, Inc	FTL	Class II	2018-07-26
K180958	Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable	Shockwave Medical, Inc.	PPN	Class II	2018-07-26
K180272	Saniclave 250	Revolutionary Science	FLE	Class II	2018-07-26
K173656	Arthrex FibuLock Nail	Arthrex GmbH	HSB	Class II	2018-07-26
K173107	Vios Central Station Monitor Software, Vios Central Server Software	Vios Medical, Inc.	DXJ	Class II	2018-07-26
K181670	Alphenix, INFX-8000V/B, V8.0	Canon Medical Systems Corporation	OWB	Class II	2018-07-25
K181495	Republic Spine Dark Star Spinal System	Republic Spine	NKB	Class II	2018-07-25
K181453	ATEC ALIF Spacer System	Alphatec Spine, Inc.	MAX	Class II	2018-07-25
K180960	FIXIT / ComposiTCP Threaded Anchor System	S.B.M. SAS Sciences for Bio Materials	MAI	Class II	2018-07-25
K180752	Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole	Corinth Medtech, Inc.	HIH	Class II	2018-07-25
K180632	Exactech Equinoxe Small Reverse Shoulder System	Exactech, Inc.	PHX	Class II	2018-07-25
K180407	Smartinhaler	Adherium (Nz), Ltd.	CAF	Class II	2018-07-25
K180226	TREND II Spinal Fixation System- STEP Series	Paonan Biotech Co., Ltd	NKB	Class II	2018-07-25
K173947	Lumbar Interbody Fusion System (OLLIF)	Advanced Research Medical	MAX	Class II	2018-07-25
K173837	RHYTHMIA HDx Mapping System (with software Version 2.0)	Boston Scientific Corporation	DQK	Class II	2018-07-25
K181686	CELERITY 20 Steam Biological Indicator	STERIS Corporation	FRC	Class II	2018-07-24
K181399	FIREFLY® Pedicle Screw Navigation Guide	Mighty Oak Medical	PQC	Class II	2018-07-24