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 440 of 3528

510(k) clearances, page 440 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K190119	Foryou NPWT Dressing Kit	4l Health Co., Ltd.	OMP	Class II	2019-11-01
K183018	VPro5	Propel Orthodontics, LLC	OYH	Class II	2019-11-01
K181993	STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)	Sturdy Industrial Co., Ltd.	FLE	Class II	2019-11-01
K192961	Adh19	3M Deutschland GmbH	KLE	Class II	2019-10-31
K192867	Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)	Bovie Medical Corporation dba Apyx Medical Corporation	GEI	Class II	2019-10-31
K192743	VisionX 2.4	Durr Dental SE	LLZ	Class II	2019-10-31
K192525	087 Balloon Guide Catheter System	Q'apel Medical, Inc.	DQY	Class II	2019-10-31
K192345	MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL	Liofilchem S.r.l.	JWY	Class II	2019-10-31
K192110	Vitek Densichek	bioMerieux, Inc.	LON	Class II	2019-10-31
K191896	Belimed Steam Sterilizer MST-H TOP 5000	Belimed AG	FLE	Class II	2019-10-31
K191769	ePM Series Patient monitors	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	MHX	Class II	2019-10-31
K191002	OR3O Dual Mobility System	Smith & Nephew, Inc.	LPH	Class II	2019-10-31
K190747	Claritag	Dgi Technologies	GEH	Class II	2019-10-31
K190281	Ultrasonic Surgical System	Medisonic Technology Co	LFL	Unclassified	2019-10-31
K190047	StimRouter Neuromodulation System	Bioness, Inc.	GZF	Class II	2019-10-31
K183412	mediCAD Web	mediCAD HECTEC GmbH	LLZ	Class II	2019-10-31
K192790	Atellica IM Total hCG (ThCG)	Siemens Healthcare Diagnostics Inc.	DHA	Class II	2019-10-30
K192783	Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile	Scientia Vascular	DQX	Class II	2019-10-30
K192775	Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri	Stereotaxis Inc	PJB	Class II	2019-10-30
K192504	Treace Medical Concepts (TMC) Plating System	Treace Medical Concepts, Inc.	HRS	Class II	2019-10-30
K192083	Okami Medical LOBO Vascular Occlusion System	Okami Medical Inc.	KRD	Class II	2019-10-30
K191264	Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)	Ujenzi Charitable Trust	OQY	Class II	2019-10-30
K191170	Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter	Innovative Health, LLC.	NLH	Class II	2019-10-30
K191134	Ib3d Alif	Medicrea International	MAX	Class II	2019-10-30
K190921	Arthrex Low Profile Screws	Arthrex GmbH	HWC	Class II	2019-10-30
K190267	EZE SIT Valvulotome	LeMaitre Vascular Inc.	MGZ	Class II	2019-10-30
K192494	NexGen Anterior Cervical Plate System	Precision Spine, Inc.	KWQ	Class II	2019-10-29
K192369	PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit	Ixensor Co Ltd	LCP	Class II	2019-10-29
K192173	ROSA ONE Spine application	MedTech LLC	OLO	Class II	2019-10-29
K192133	Zimmer Biomet Universal Navigation System	Highridge Medical, LLC	OLO	Class II	2019-10-29
K192121	Black Diamond Pedicle Screw System	Osseus Fusion Systems LLC	NKB	Class II	2019-10-29
K192114	Game Ready GRPro 2.1 System	Cool Systems, Inc. (dba Game Ready)	IRP	Class II	2019-10-29
K192053	W Zirconia Implants	TAV Medical	DZE	Class II	2019-10-29
K192041	G21 SpaceFlex Hip	G21, S.r.l.	MBB	Class II	2019-10-29
K191925	MATRx Plus	Zephyr Sleep Technologies	MNR	Class II	2019-10-29
K191862	Compression Therapy Device Model LGT-2200SP	Guangzhou Longest Science & Technology Co., Ltd.	IRP	Class II	2019-10-29
K191855	EmFace Device	Inmode MD, Ltd.	PBX	Class II	2019-10-29
K191385	Brilliant Componeer	Coltene /Whaledent AG	EBF	Class II	2019-10-29
K192802	primeMidline Catheters	PFM Medical GmbH	PND	Class II	2019-10-28
K192673	3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228	3M Company	JOJ	Class II	2019-10-28
K192046	LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set	Diasorin Inc.	QFO	Class II	2019-10-28
K192029	Straumann PUREloc abutments	Straumann USA, LLC	NHA	Class II	2019-10-28
K191881	KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun	Kbl AG	LEJ	Class II	2019-10-28
K182605	HS AMICA devices family	H.S. Hospital Service S.p.A.	GEI	Class II	2019-10-28
K180347	3d Cage	Fims Co., Ltd.	MAX	Class II	2019-10-28
K190624	EarlyVue VS30	Philips Medizin Systeme Boeblingen GmbH	DSJ	Class II	2019-10-27
K192787	Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System	Dexcom, Inc.	QDK	Class II	2019-10-25
K192725	Cytal Wound Matrix 3-Layer	ACell, Inc	KGN	Unclassified	2019-10-25
K192705	MiniCap Extended Life PD Transfer Sets	Baxter Healthcare Corporation	KDJ	Class II	2019-10-25
K192667	gel-e Flex+ gel OTC	Gel-E, Inc.	QSY	Unclassified	2019-10-25