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 366 of 3528

510(k) clearances, page 366 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K210054	Cios Spin	Siemens Medical Systems USA, Inc.	OWB	Class II	2021-02-05
K210053	LVivo Software Application	Dia Imaging Analysis, Ltd.	QIH	Class II	2021-02-05
K210036	Carnation Ambulatory Monitor (CAM)	Bardy Diagnostics, Inc.	DSH	Class II	2021-02-05
K203635	Patient Monitoring Cables	JKH USA, LLC	DSA	Class II	2021-02-05
K203588	ELEOS™ Limb Salvage System	Onkos Surgical, Inc.	JDI	Class II	2021-02-05
K203475	LimaCorporate Kirschner Wire	Lima Corporate S.p.A.	HTY	Class II	2021-02-05
K203374	X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)	De Gotzen S.r.l.	MUH	Class II	2021-02-05
K203334	The Citrefix Knotless Suture Anchor	Acuitive Technologies	MAI	Class II	2021-02-05
K203319	SYMPHONY™ OCT System	Medos International SARL	NKG	Class II	2021-02-05
K203302	GentleWave X	Sonendo Inc	ELC	Class II	2021-02-05
K203290	Bonelogic	Disior Oy	LLZ	Class II	2021-02-05
K201421	Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons	Dukal LLC	FXX	Class II	2021-02-05
K201324	Antibacterial Bandage	Jiangsu Excellence Medical Supplies Co., Ltd	FRO	Unclassified	2021-02-05
K201306	Hamilton-C3	Hamilton Medical AG	CBK	Class II	2021-02-05
K201121	Sphincterotome	Hangzhou AGS MedTech Co., Ltd.	KNS	Class II	2021-02-05
K200470	Shofu Block HC Hard	Shofu Dental Corp.	EBF	Class II	2021-02-05
K200368	LINK Embrace Shoulder System - Reverse Configuration	Waldemar Link GmbH & Co. KG	PHX	Class II	2021-02-05
K200320	Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload	M/s. Meril Endo Surgery Private Limited.	GDW	Class II	2021-02-05
DEN200018	eXciteOSA with remote and eXciteOSA without remote	Signifier Medical Technologies Limited	QNO	Class II	2021-02-05
K210174	BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set	BEMER Int. AG	NGX	Class II	2021-02-04
K203582	QUIBIM Precision Prostate (qp-Prostate)	Quibim S.L.	LLZ	Class II	2021-02-04
K203573	RESPONSE Navigation Instruments	Orthopediatrics Corp	OLO	Class II	2021-02-04
K202872	Prase PEEK Anterior Cervical Interbody Spacer	Gbs Commonwealth Co., Ltd.	ODP	Class II	2021-02-04
K202493	Medical Face Mask	Gemtier Medical (Shanghai) Inc.	FXX	Class II	2021-02-04
K203598	Omnichroma Flow Bulk	Tokuyama Dental Corporation	EBF	Class II	2021-02-03
K203420	EcoFit® Hip System	implantcast GmbH	LZO	Class II	2021-02-03
K203294	Arthrex Pilon Fusion System	Arthrex GmbH	HRS	Class II	2021-02-03
K202627	Medical Face Masks	Guilin Hbm Sanitary Protections, Inc.	FXX	Class II	2021-02-03
K202151	Smart SPACE Shoulder System	Techmah Medical, LLC	QHE	Class II	2021-02-03
K202027	Balex bone Expander System	Taeyeon Medical Co., Ltd.	HRX	Class II	2021-02-03
K200636	AXUS ES-5 Electro-Acupuncture Device	Lhasa Oms, Inc.	BWK	Unclassified	2021-02-03
K200301	UNiTi ACDF Implant System	Pressio, Inc.	PHQ	Class II	2021-02-03
K192568	Jiajian Self-Adhesive Electrode	Wuxi Jiajian Medical Instrument Co., Ltd	GXY	Class II	2021-02-03
K203667	EzRay M (Model: VMX-P300)	Vatech Co., Ltd.	IZL	Class II	2021-02-02
K203634	BioPoly Great Toe Hemiarthroplasty Implant	Biopoly, LLC	KWD	Class II	2021-02-02
K203553	Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR	Canon Medical Systems Corporation	LNH	Class II	2021-02-02
K203299	CellFX System	Pulse Biosciences, Inc.	GEI	Class II	2021-02-02
K203278	INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers	Globus Medical, Inc.	MAX	Class II	2021-02-02
K202511	Disposable Medical Surgical Mask	Improve Medical (Hunan) Co., Ltd.	FXX	Class II	2021-02-02
K202331	Medical Face Mask	Gemtier Medical (Shanghai) Inc.	FXX	Class II	2021-02-02
K202323	Disposable Medical Surgical Masks	Tianjin Teda Jinshan Easy Packing Manufacture Co., Ltd.	FXX	Class II	2021-02-02
K202097	Fundus Camera	Huvitz Co., Ltd.	HKI	Class II	2021-02-02
K202096	3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On	Ecoguard Inc	FXX	Class II	2021-02-02
K201231	CTxx85 CT Scanner	Analogic Corp.	JAK	Class II	2021-02-02
K193422	Easydrip Pen Needle, Easydrip Plus Pen Needle	Sandstone Medical (Suzhou) Inc.	FMI	Class II	2021-02-02
K203794	HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture	Medos International SARL	MBI	Class II	2021-02-01
K203603	Monopolar Hook	Human Xtensions, Ltd.	GCJ	Class II	2021-02-01
K203568	Hoffmann LRF System	Stryker Corp.	KTT	Class II	2021-02-01
K203537	Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems	Sedecal S.A.	KPR	Class II	2021-02-01
K203483	Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves	Guilin HBM Health Protections, Inc.	KGO	Class I	2021-02-01