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 384 of 3528

510(k) clearances, page 384 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K202364	Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1	Canon Medical Systems Corporation	IYN	Class II	2020-10-15
K202349	Cartesion Prime, PCD-1000A, V10.7	Canon Medical Systems Corporation	KPS	Class II	2020-10-15
K202340	Droplet Pen Needle 30G & 33G	HTL-Strefa S.A.	FMI	Class II	2020-10-15
K202327	Invictus™ OsseoScrew® System	Alphatec Spine, Inc.	NKB	Class II	2020-10-15
K202041	Opera Evo	Quanta System Inc.	GEX	Class II	2020-10-15
K201908	LIAISON Testosterone xt	Diasorin Inc.	CDZ	Class I	2020-10-15
K201615	Signa 7.0T	GE Healthcare	LNH	Class II	2020-10-15
K201587	icotec Anterior Cervical Plate System	Icotec AG	KWQ	Class II	2020-10-15
K201398	SINUSPRIME Dilation System	Stryker Ent	LRC	Class I	2020-10-15
K200764	Statstix	Centrix Incorporated	MVL	Unclassified	2020-10-15
K200757	Foley Catheter with Temperature Sensor	DeRoyal Industries, Inc.	EYC	Class II	2020-10-15
K200718	Arthrosurface WristMotion Total Wrist Arthroplasty System	Arthrosurface, Inc.	JWJ	Class II	2020-10-15
K200296	Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses	Pegavision Corporation	LPL	Class II	2020-10-15
K200207	xPORT S Lens Fragmentation System	Carl Zeiss Meditec Cataract Technology Inc	HQC	Class II	2020-10-15
K202666	CONSTRUX Mini PTC Spacer System	Orthofix SRL	ODP	Class II	2020-10-14
K201595	Merit Hydrophilic Guide Wire	Merit Medical Systems, Inc.	DQX	Class II	2020-10-14
K201562	Spirotrac	Vitalograph Ireland Ltd.	BZG	Class II	2020-10-14
K200386	Z5-Bl	Z-Systems AG	DZE	Class II	2020-10-14
K202305	Zavation IBF System	Zavation Medical Products, LLC	MAX	Class II	2020-10-13
K201962	Skeletal Dynamics Ulnar Shortening Plating System	Skeletal Dynamics, Inc	HRS	Class II	2020-10-13
K200596	G21 Cement, VADER® Pedicle System	Icotec AG	PML	Class II	2020-10-13
K200114	Astroglide Organix Liquid	Biofilm, Inc.	NUC	Class II	2020-10-13
K202501	Quantib Prostate	Quantib B.V.	LLZ	Class II	2020-10-11
K202213	syngo.CT Neuro Perfusion	Siemens Medical Solutions USA, Inc.	JAK	Class II	2020-10-11
K201828	Voluson SWIFT, Voluson SWIFT+	GE Healthcare	IYN	Class II	2020-10-11
K201528	Yushan X-Ray Flat Panel Detector with DROC	Innocare Optoelectronics Corp.	MQB	Class II	2020-10-11
K200633	Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove	0 & M Halyard, Inc.	LZC	Class I	2020-10-11
K202740	Klassic Knee System Tibial Inserts, PS-Max	Total Joint Orthopedics, Inc.	JWH	Class II	2020-10-09
K202609	Instrument Clamps Electromagnetic	Stryker Corp.	PGW	Class II	2020-10-09
K202285	Medline ENfit OTC Feeding Syringe	MEDLINE INDUSTRIES, LP - Northfield	PNR	Class II	2020-10-09
K201983	BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)	Med-el Elektromedizinische Geraete, GmbH	PFO	Class II	2020-10-09
K201882	AEON Endoscopic Stapler	Lexington Medical, Inc.	GDW	Class II	2020-10-09
K201377	SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter	Cordis US Corp.	LIT	Class II	2020-10-09
K201038	Luce Ceramic Bracket	Luce Castle Co., Ltd.	NJM	Class II	2020-10-09
K200510	Multi-LinkTM X2 ECG Adapter and Leadwires	Jaeger Medical GmbH	DSA	Class II	2020-10-09
K200434	V20, V20a, AVSM3 SNF	Mediana Co., Ltd.	DXN	Class II	2020-10-09
K200103	BIOTEQ Drainage Catheter Set (One Step Type)	Bioteque Corp.	FGE	Class II	2020-10-09
K193631	Stethee Pro 1, Stethee Pro Software System	M3Dicine Pty, Ltd.	DQD	Class II	2020-10-09
K192921	Zeos Aqua Vision Pump and tube	Hemodia SAS	HRX	Class II	2020-10-09
K202592	Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adavanced Imaging Modality)	Stryker Corp.	GCJ	Class II	2020-10-08
K202478	Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares	Boston Scientific Corporation	FDI	Class II	2020-10-08
K202309	Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System	Highridge Medical, LLC	KWQ	Class II	2020-10-08
K201972	Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1	Canon Medical Systems Corporation	IYN	Class II	2020-10-08
K201970	Schoelly Cystoscopes/Hysteroscopes and Accessories	Schoelly Fiberoptic, GmbH	HIH	Class II	2020-10-08
K201939	GAIA Lumbar Interbody Fusion Device (LIFD) Family	Printerprezz	MAX	Class II	2020-10-08
K201917	Piccolo Composite Proximal Tibia Plate System	CarboFix Orthopedics Inc.	HRS	Class II	2020-10-08
K201845	Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)	Guangzhou Longest Science & Technology Co., Ltd.	NGX	Class II	2020-10-08
K201777	31Hn713d	LG Electronics.Inc	PGY	Class II	2020-10-08
K201525	ECG App	Apple Inc.	QDA	Class II	2020-10-08
K201483	Impression Material	Zhengzhou Huaer Electro-Optics Technology Co., Ltd.	ELW	Class II	2020-10-08