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 2026-11-02, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1043 of 3531

510(k) clearances, page 1043 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K093391	Simuplan Treatment Planning System	Simuplan S.L.	MUJ	Class II	2009-12-23
K093242	Patriot Transcontinental Llif Spacer	Globus Medical, Inc.	MAX	Class II	2009-12-23
K093098	Aution Max Model Ax-4030 Urinalysis System	Arkray, Inc.	KQO	Class I	2009-12-23
K093077	Zodiac Polyaxial Spinal Fixation System	Alphatec Spine, Inc.	MNI	Class II	2009-12-23
K092998	Conmed Linvatec Intercept Implant	Linvatec Corporation	MBI	Class II	2009-12-23
K092837	Oti-Scan 3000	Opko Instrumentation, Inc.	IYO	Class II	2009-12-23
K092803	Cardo Medical Align 360 Medialized Patella Component	Cardo Medical Corp.	JWH	Class II	2009-12-23
K092510	Fully Automatic Electronic Blood Pressure Monitor, Models Kd-7901, Kd-7905, Kd-7911	Andon Health Co., Ltd	DXN	Class II	2009-12-23
K092469	O-Scan Mr System	Esaote S.p.A.	LNH	Class II	2009-12-23
K092438	Ziehm Solo	Ziehm Imaging GmbH	OWB	Class II	2009-12-23
K092371	Swift-Lock Anchor, Model 1192	Abbott Medical	GZB	Class II	2009-12-23
K091749	U by Kotex Click* Unscented Tampons, Model Absorbency: Regular, Super and Super Plus	Kimberly-Clark Corporation	HEB	Class II	2009-12-23
K091729	Alpha-Bsm, Beta-Bsm, Gamma-Bsm, Equivabone	Etex Corp.	LYC	Class II	2009-12-23
K091644	Synthes (USA) 2.4Mm Lcp Volar Column Distal Radius Plates	Synthes (USA) Products LLC	HRS	Class II	2009-12-23
K091579	Foresee Home	Notal Vision Ltd.	HPT	Class I	2009-12-23
K091426	Cervicore Corpectomy Cage	Verticor, Ltd.	MQP	Class II	2009-12-23
K091265	Zoll E Series with Cprreadycharge	ZOLL Medical Corporation	MKJ	Class III	2009-12-23
K090832	Rapid-I	Vitrolife Sweden AB	MQK	Class II	2009-12-23
K090820	Tria Hair Removal Laser System	Spectragenics, Inc.	GEX	Class II	2009-12-23
K090819	Ontex Tampon (Unscented)	Ontex International NV	HEB	Class II	2009-12-23
K090690	Venous Softbag Reservoirs with Softline Coating	MAQUET CARDIOPULMONARY GmbH	DTN	Class II	2009-12-23
K090555	Plegiox Cardioplegia Heat Exchanger with Softline Coating, Model Bio-Chx 30	MAQUET CARDIOPULMONARY GmbH	DTR	Class II	2009-12-23
K090534	Venous Hardshell Cardiotomy Reserviors	MAQUET CARDIOPULMONARY GmbH	DTN	Class II	2009-12-23
K093483	Atlantis Abutment for Nobel Biocare Active Implant, Atlantis Gemini Abutment, Gemini + Abutment	Astra Tech, Inc.	NHA	Class II	2009-12-22
K093439	Powder-Free Vinyl Patient Examination Gloves	Tangshan Pufa Plastic Products Co., Ltd.	LYZ	Class I	2009-12-22
K093167	Sta Compact Automated Multi-Parametric Analyzer	Diagnostica Stago, Inc.	JPA	Class II	2009-12-22
K093025	Bovie Resistick II Coated Electrosurgical Electrodes	Apyx Medical Corporation	GEI	Class II	2009-12-22
K093019	Enamelite Acryseal Spray Sealant	Enamelite, LLC	EBD	Class II	2009-12-22
K092904	Pathway Ivb/vbr	Custom Spine, Inc.	ODP	Class II	2009-12-22
K092796	Iba Proton Therapy System, Proteus 235	Ion Beam Applications S.A.	LHN	Class II	2009-12-22
K092186	Vpap Tx	ResMed Corp	MNS	Class II	2009-12-22
K092170	Sta Liatest Free Ps	Diagnostica Stago, Inc.	GGP	Class II	2009-12-22
K091926	Choice Spine Anterior Cervical Plate (Acp) System	Choicespine, LP	KWQ	Class II	2009-12-22
K091762	Dura-Stick Self-Adhesive Electrodes with Aloe	Medtronic, Inc.	GXY	Class II	2009-12-22
K091701	Straumann Modified Dental Abutment	Straumann USA, LLC	NHA	Class II	2009-12-22
K091543	Legion Porous Plus Ha Primary Femoral Components	Smith & Nephew, Inc.	MBH	Class II	2009-12-21
K090435	Vertecem	Teknimed SAS	NDN	Class II	2009-12-21
K093644	Restoration Adm System X3 Acetabular	Howmedica Osteonics Corp	MEH	Class II	2009-12-18
K093601	Af 840 Ph.i.s.i.o. Arterial Filter	Corcym Inc.	DTM	Class II	2009-12-18
K093557	Smartwand-Dtx	Clearcount Medical Solutions, Inc.	LWH	Class I	2009-12-18
K093177	Intellibridge System	Philips North America LLC	MWI	Class II	2009-12-18
K093113	Etkon Es1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment	Straumann USA, LLC	NHA	Class II	2009-12-18
K093050	Arrow Seldinger Arterial Catherization Devices, Models Ex Sac 00520	Arrow Intl., Inc.	DQY	Class II	2009-12-18
K093001	Sta-R Evolution Expert Series Hemostasis System Automated Multi-Parametric Analyzer	Diagnostica Stago, Incorporated	JPA	Class II	2009-12-18
K092910	Fluid-Filled Teether	Qualiman Industrial Co., Ltd.	KKO	Class II	2009-12-18
K092883	LED Lamp or Other	Intravista Medical Systems, Inc.	HJO	Class II	2009-12-18
K092823	Amsco Warming Cabinet	STERIS Corporation	LGZ	Class II	2009-12-18
K092788	Periophil Biphasic	Cytophil, Inc	LYC	Class II	2009-12-18
K092648	Respironics Performax Se Total Face Mask	Respironics Inc., Sleep & Home Respiratory Group	CBK	Class II	2009-12-18
K092546	Gmdasz TENS Electrodes, Models Cwn1005, Dia. 5Cm, Dwn2505, 5Cmx5cm, Cwn1007.dia. 7Cm, Cwn2509,5cmx9cm	Gmdasz Manufacturing Co., Ltd.	GXY	Class II	2009-12-18