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 301 of 3528

510(k) clearances, page 301 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K214091	Dental Image Plate Scanner, Model DFC-4T-SMART	Hefei Dentafilm Medical Equipment Co., Ltd.	MUH	Class II	2022-03-02
K213932	A-dec 300, A-dec 500	A-dec, Inc.	EIA	Class I	2022-03-02
K213579	Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph	Fona S.R.L	OAS	Class II	2022-03-02
K213567	Medline UNITE Calcaneal Fracture Plating System	MEDLINE INDUSTRIES, LP - Northfield	HRS	Class II	2022-03-02
K213553	Giraffe Incubator Carestation CS1	GE Healthcare	FMZ	Class II	2022-03-02
K213551	Giraffe Omnibed Carestation CS1	GE Healthcare	FMT	Class II	2022-03-02
K213457	Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135	Fort Defiance Industries, LLC	FLE	Class II	2022-03-02
K213279	NovaGuide 2 Intelligent Ultrasound	NeuraSignal, Inc.	IYN	Class II	2022-03-02
K213135	Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge	Chirurgie Innovation	FAS	Class II	2022-03-02
K213127	ReNew Disposable Scissor Tips	Microline Surgical, Inc	GEI	Class II	2022-03-02
K212698	Plus Medical Isolation Gown Level 3	Foshan Nanhai Plus Medical Co Ltd	FYC	Class II	2022-03-02
K212652	Sterile Syringe with Fixed Safety Needle for Single Use	Gemtier Medical (Shanghai) Inc.	MEG	Class II	2022-03-02
K212379	N Latex FLC kappa, N Latex FLC lambda	Siemens Healthcare Diagnostics Products Limited	DFH	Class II	2022-03-02
K211183	Sugita AVM Microclips	Mizuho America, Inc.	HCH	Class II	2022-03-02
K210923	Southern Implants Instrument Trays	Southern Implants, (Pty.) Ltd.	KCT	Class II	2022-03-02
K203376	ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G	Medtecs (Taiwan) Corp.	FXX	Class II	2022-03-02
K201861	Bio Fluff System	Gnali Bocia S.r.l.	KPL	Class II	2022-03-02
K220109	DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System	Cardiovascular Systems Incorporated	MCW	Class II	2022-03-01
K213590	Blue Topaz Sacroiliac Screw System	Osseus Fusion Systems LLC	OUR	Class II	2022-03-01
K213400	Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry	Rb Health (Us), LLC	NUC	Class II	2022-03-01
K213189	Wrist-type Fully Automatic Digital Blood Pressure Monitor	Joytech Healthcare Co., Ltd.	DXN	Class II	2022-03-01
K212945	Sterile Disposable Temperature Probe	Shenzhen Envisen Industry Co. Ltd.	FLL	Class II	2022-03-01
K212596	Sterile Latex Surgical Gloves Powder Free	Amazing Rubber Products Pvt. Ltd	KGO	Class I	2022-03-01
K212365	BoneView	Gleamer	QBS	Class II	2022-03-01
K212187	Restoration® Modular Hip System	Howmedica Osteonics Corp., dba Stryker Orthopaedics	LPH	Class II	2022-03-01
K212057	Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS	Artventive Medical Group, Inc.	KRD	Class II	2022-03-01
K211868	Myah	VISIA imaging S.r.l.	MXK	Class II	2022-03-01
K211802	GoBack Crossing Catheter	Upstream Peripheral Technologies Ltd.	PDU	Class II	2022-03-01
K211776	Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)	Microlife Intellectual Property GmbH	FLL	Class II	2022-03-01
K211484	Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles	Shinva Ande Healthcare Apparatus Co., Ltd.	MEG	Class II	2022-03-01
K210848	Sure-Fine Insulin Syringes	Shina Med Corporation	FMF	Class II	2022-03-01
K210811	Dynamyx Digital Pathology Software	Inspirata, Inc.	QKQ	Class II	2022-03-01
K210151	Digimamo D	Vmi Tecnologias Ltda	MUE	Class II	2022-03-01
K210075	Vigilant Software Suite – Vigilant Master Med	Fresenius Kabi AB	PHC	Class II	2022-03-01
K210074	Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable	Fresenius Kabi AB	FRN	Class II	2022-03-01
K210073	Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo	Fresenius Kabi AB	FRN	Class II	2022-03-01
K202046	LOTA SLA Dental Implant System and LOTA HA Dental Implant System	KJ Meditech Co., Ltd.	DZE	Class II	2022-03-01
K213750	VyLink™ Spinal Screw System	VY Spine, LLC	NKB	Class II	2022-02-28
K213635	Vathin Video Bronchoscope System	Hunan Vathin Medical Instrument Co., Ltd.	EOQ	Class II	2022-02-28
K212833	Disposable Nitrile Examination Gloves	Chifeng Huawei Medical Science&Technology Co., Ltd.	LZA	Class I	2022-02-28
K211661	ENFit enteral syringes (NUTRIFIT)	Pentaferte Italia S.r.l.	PNR	Class II	2022-02-28
K193406	CardioChek Plus Test System; CardioChek Plus Home Test System	Polymer Technology Systems, Inc. D/B/A Pts Diagnostics	NBW	Class II	2022-02-26
K220238	Cohitech Cottonlock Tampons with Reusable Applicator	Cotton High Tech S.L.	HEB	Class II	2022-02-25
K220217	Normatec 3	Normatec Industries, LP	IRP	Class II	2022-02-25
K214097	Explorer Air II	Surgvision GmbH	IZI	Class II	2022-02-25
K214066	FEops HEARTguide	Feops NV	QQI	Class II	2022-02-25
K213693	MAGNETOM Vida with syngo MR XA50A	Siemens Medical Solutions USA, Inc.	LNH	Class II	2022-02-25
K213241	VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole	bioMerieux, Inc.	LON	Class II	2022-02-25
K213084	Ear Thermometer, Model ET005, ET008, ET009	Guangzhou Berrcom Medical Device Co., Ltd	FLL	Class II	2022-02-25
K213043	Levator Elite (Model LE9011)	Shenzhen Dongdixin Technology Co., Ltd.	IPF	Class II	2022-02-25