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 2026-10-12, 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 245 of 3528

510(k) clearances, page 245 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K221252	Scivita 4KINSIGHT ICG Imaging System	Scivita Medical Technology Co., Ltd.	GCJ	Class II	2023-01-13
K221020	Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F	Potrero Medical, Inc.	EZL	Class II	2023-01-13
K220495	SignaSure Dual Mobility System	Signature Orthopaedics Pty Limited	MEH	Class II	2023-01-13
K214078	Silk’n Toothwave	Home Skinovations, Ltd.	QMJ	Class II	2023-01-13
K213514	Spectricept Skin and Wound Cleanser	Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.	FRO	Unclassified	2023-01-13
K223782	Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set	Ambu A/S	EOQ	Class II	2023-01-12
K223731	NuVasive Modulus-C Interbody System	NuVasive Inc	ODP	Class II	2023-01-12
K223644	Neuronaute with IceCap 2 & IceCap 2 Small	Bioserenity	GWQ	Class II	2023-01-12
K223363	MAMMOVISTA B.smart (VB70)	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2023-01-12
K222976	MU System	Dentis Co.,Ltd	NHA	Class II	2023-01-12
K222830	Rainbow 360	Kerr Corporation	KLE	Class II	2023-01-12
K222458	Aibolit 3D+	Aibolit Technologies, LLC	LLZ	Class II	2023-01-12
K222150	PreXion3D Expedition	Prexion Corporation	OAS	Class II	2023-01-12
K222011	HandX Instrument - Monopolar Spatula	Human Xtensions, Ltd.	GCJ	Class II	2023-01-12
K221873	NeoGen PSR System	Energist Limited	GEI	Class II	2023-01-12
K221774	Garmin ECG App	Garmin International, Inc.	QDA	Class II	2023-01-12
K223931	Dexcom G6 Continuous Glucose Monitoring (CGM) System	Dexcom, Inc.	QBJ	Class II	2023-01-11
K223764	INFINITY OCT System	Medtronic Sofamor Danek USA Inc	NKG	Class II	2023-01-11
K223738	Alpha Control Liner System (ACLS)	Coapt LLC	GXY	Class II	2023-01-11
K223719	Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System	Aegis Spine, Inc.	KWQ	Class II	2023-01-11
K223465	RadianceTx Radionuclide Brachytherapy Source	Radiance Therapeutics, Inc.	KXK	Class II	2023-01-11
K223295	Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D	Fujifilm Corporaton	FDA	Class II	2023-01-11
K223181	NuVasive Reline System	Nu Vasive, Incorporated	NKB	Class II	2023-01-11
K223000	Artix BG	Inari Medical, Inc.	QEW	Class II	2023-01-11
K222181	Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate	Iconic Medicare Sdn Bhd	LZA	Class I	2023-01-11
K221278	Transducer Probe Cover	Hony Medical Co., Ltd	ITX	Class II	2023-01-11
K191111	DD Solid Connect® CAD/CAM Abutments	Dental Direkt GmbH	NHA	Class II	2023-01-11
K222799	Haymaker® Screw System	Orthocircle Spine D.B.A. OC Medical Devices	HWC	Class II	2023-01-10
K222115	ISAAC Neurovascular Navigation Catheter	Terumo Cardiovascular Systems Corporation	DQY	Class II	2023-01-10
K221090	Metal Cannulated Screw	Double Medical Technology Inc.	HWC	Class II	2023-01-10
K211047	CoCr Head	Zimmer GmbH	LPH	Class II	2023-01-10
K223789	21Hq513d	LG Electronics.Inc	PGY	Class II	2023-01-09
K223336	Vitrea Software Package, VSTP-002A	Canon Medical Systems Corporation	LLZ	Class II	2023-01-09
K222789	VADER® Pedicle System, G21 Cement	Icotec AG	PML	Class II	2023-01-09
K222787	Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P	Chongqing Sunkingdom Medical Instrument Co.,Ltd	IYO	Class II	2023-01-09
K222711	HS186B Scooter	Suzhou Master Machinery Manufacturing Co.,Ltd.	INI	Class II	2023-01-09
K211163	Bone Cement Genta, Bone Cement HV, Bone Cement LV	Tecres SpA	LOD	Class II	2023-01-09
K223749	U by Kotex® Click® Unscented Menstrual Tampons	Kimberly-Clark Corporation	HEB	Class II	2023-01-06
K223675	WatchPAT ONE (WP1)	Itamar Medical	MNR	Class II	2023-01-06
K223412	LumiVy™ Lumbar IBF System	VY Spine, LLC	MAX	Class II	2023-01-06
K223200	Curiteva Navigation System	Curiteva, Inc.	OLO	Class II	2023-01-06
K222577	TECHFIT Diagnostic Models	Techfit Digital Surgery, Inc.	LLZ	Class II	2023-01-06
K222296	ARTICUL/EZE Ceramic Heads	Depuy Ireland UC	LZO	Class II	2023-01-06
K221260	Csf-3	Cardiacsense	DPS	Class II	2023-01-06
K213423	T3 Platform software	Etiometry Inc.	PLB	Class II	2023-01-06
K211812	BLUEDIAMOND IMPLANT, Abutment Screw	Megagen Implant Co., Ltd.	DZE	Class II	2023-01-06
K203380	Disposable Surgical Face Mask	Shandong Pop Jeans Intelligent Manufacturing Co., Ltd.	FXX	Class II	2023-01-06
K223671	CONDUIT LLIF Straight Inserters	Enztec Limited	MAX	Class II	2023-01-05
K223650	REMEDY Stemmed Knee Spacer	Osteoremedies, LLC	JWH	Class II	2023-01-05
K221266	Cervical Spine Truss System (CSTS) Interbody Fusion Device	4Web Medical, Inc.	ODP	Class II	2023-01-05