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 2026-10-21, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 534 of 3529

510(k) clearances, page 534 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K173079	Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4	Philips Medical Systems Nederland B.V.	LNH	Class II	2018-04-04
K173074	ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor	Stryker Corp.	MBI	Class II	2018-04-04
K173072	Algidex Ag Silver Alginate Wound Dressing	DeRoyal Industries, Inc.	FRO	Unclassified	2018-04-04
K172963	Master-Frank N95 Particulate Respirator	Master & Frank Enterprise Co., Ltd.	MSH	Class II	2018-04-04
K172239	Simplant 18	Dentsply Sirona Inc	LLZ	Class II	2018-04-04
K172141	Pulse Oximeter	Shanghai Berry Electronic Tech Co., Ltd.	DQA	Class II	2018-04-04
K180677	Surefire Spark Infusion System	Surefire Medical, Inc.	DQO	Class II	2018-04-03
K180597	AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO	Lumenis Ltd	GEX	Class II	2018-04-03
K180566	Unite Connect for Clinical Systems	Ascom Sweden AB	MSX	Class II	2018-04-03
K180503	PRECICE STRYDE System	NuVasive Specialized Orthopedics, Inc.	HSB	Class II	2018-04-03
K180320	dpl IIa Panel	LED Technologies, Inc.	OHS	Class II	2018-04-03
K180243	Infinity-Lock Button System	Xiros Ltd	HTN	Class II	2018-04-03
K173958	OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens	Visco Vision Inc.	LPL	Class II	2018-04-03
K173885	Genesys Spine Binary Lumbar Plate System	Genesys Spine	KWQ	Class II	2018-04-03
K173506	LigaPASS	Medicrea International	OWI	Class II	2018-04-03
K173362	DSM Biomedical Calcium Phosphate Cement	Kensey Nash Corporation dba Dsm Biomedical	MQV	Class II	2018-04-03
K172635	High-Flo Silver Polyethylene Catheter	Cook Incorporated	DQO	Class II	2018-04-03
K172630	Kisses Plus Implant System	Achimhai Medical Corporation	DZE	Class II	2018-04-03
DEN170047	Curetis Unyvero LRT Application	Curetis GmbH	QBH	Class II	2018-04-03
K180586	Varian Head Frame	Varian Medical Systems, Inc.	IYE	Class II	2018-04-02
K180210	CREO® Stabilization System	Globus Medical, Inc.	NKB	Class II	2018-04-02
K173896	Microcyn Antimicrobial Hydrogel	Sonoma Pharmaceuticals, Inc.	FRO	Unclassified	2018-04-02
K173669	K-D Balance	King-Devick Technologies, Inc	LXV	Unclassified	2018-04-02
K173639	Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax	Siemens Medi Cal Solutions, Inc.	OWB	Class II	2018-04-02
K172382	GC Fuji Direct	GC America Inc.	EMA	Class II	2018-04-02
K171692	Instrument basket, for EndoEYE	Olympus Winter & Ibe GmbH	KCT	Class II	2018-04-02
K180592	G-scan Brio	Esaote S.p.A.	LNH	Class II	2018-03-30
K180538	gammaCore Sapphire	Electrocore, Inc.	PKR	Class II	2018-03-30
K180323	Vitrea Software Package; VSTP-001A	Canon Medical Systems Corporation	LLZ	Class II	2018-03-30
K180194	SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System	Paragonix Technologies Inc.	MSB	Class II	2018-03-30
K173789	Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon	Elekta Instrument AB	IWB	Class II	2018-03-30
K173637	syngo.CT Coronary Analysis; syngo.CT Vascular Analysis	Siemens Medical Solutions USA, Inc.	JAK	Class II	2018-03-30
K173630	SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence	Siemens Medical Solutions USA, Inc.	JAK	Class II	2018-03-30
K173617	MAGNETOM Vida with Compressed Sensing GRASP-VIBE	Siemens Medical Solutions USA, Inc.	LNH	Class II	2018-03-30
K173548	Merit Pursue Microcatheter	Merit Medical Systems, Inc.	DQY	Class II	2018-03-30
K173517	RADspeed fit	Shimadzu Corp.	KPR	Class II	2018-03-30
K173379	Straumann Variobase for Crown AS	Straumann USA, LLC	NHA	Class II	2018-03-30
K173029	Nipro Syringe	Nipro Medical Corporation	FMF	Class II	2018-03-30
K172335	Bleep DreamPort	Snapcpap	BZD	Class II	2018-03-30
K172312	eego amplifiers	Eemagine Medical Imaging Solutions GmbH	GWL	Class II	2018-03-30
K172246	Olympus Urf-V2/v2r	Olympus Medical Systems Corp.	FGB	Class II	2018-03-30
K172078	ImmuLisa Enhanced RNA POL III Antibody ELISA	Immco Diagnostics, Inc.	NYO	Class II	2018-03-30
K171997	Mandril Wire Guide	Cook Incorporated	DQX	Class II	2018-03-30
K171988	Performer Guiding Sheath	Cook Incorporated	DYB	Class II	2018-03-30
K171952	Dimesol Tubing Sets for Hemodialysis	Dimesol, Inc.	FJK	Class II	2018-03-30
K171867	Dr’s Finder NEO	Good Doctors Co., Ltd.	LQY	Unclassified	2018-03-30
K171857	AMSure® Enteral Feeding Syringe with ENFit Tip	Amsino International, Inc.	PNR	Class II	2018-03-30
K170608	UF(II) Implant System	Dio Corporation	DZE	Class II	2018-03-30
K180535	Voluson P6 and Voluson P8	GE Healthcare	IYN	Class II	2018-03-29
K180531	NovoStitch Pro Meniscal Repair System	Ceterix Orthopaedics, Inc.	GAT	Class II	2018-03-29