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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 802 of 3530

510(k) clearances, page 802 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K132441	Bard Ventralex Hernia Patch	C.R. Bard Inc	FTL	Class II	2013-12-13
K132060	Durablue Sterilization Wrap	Medtronic, Inc.	FRG	Class II	2013-12-13
K132015	Truclear Morcellation System and Truclear Morcellators	Smith & Nephew, Inc.	HIH	Class II	2013-12-13
K131996	S-Scan	Esaote S.p.A.	LNH	Class II	2013-12-13
K131979	Provant Therapy System	Regenesis Biomedical Inc	ILX	Class II	2013-12-13
K130913	Genesys Spine Apache Lateral Lumbar Interbody Fusion System	Genesys Spine	MAX	Class II	2013-12-13
K130738	Endoscopic Linear Cutting Staplers with Single Use Loading Units	Nanjing Maidixin Medical Device Co., Ltd.	GDW	Class II	2013-12-13
K130704	Microdose Si	Philips Digital Mammography Sweden AB	MUE	Class II	2013-12-13
K122035	Hepafat Scan	Resonance Health Analysis Services Pty Ltd	LNH	Class II	2013-12-13
K121248	Liquoguard Csf Liquoguard Csf Tubing Set (1500Mm) Liquoguard Csf Tubing Set (2000Mm) Safety Cushion for Tubing Set Attac	Moller Medical GmbH	JXG	Class II	2013-12-13
DEN130022	Neuralieve Cerena Transcranial Magnetic Stimulator	Eneura Therapeutics	OKP	Class II	2013-12-13
K133435	Magnetom Aera and Skyra with Software Mr D13a	Siemens Medical Solutions USA, Inc.	LNH	Class II	2013-12-12
K133230	Inqwire Diagnostic Guide Wire	Merit Medical Systems, Inc.	DQX	Class II	2013-12-12
K133074	Mega 8Fr. 50Cc and Sensation Plus 8Fr. 50Cc Intra-Aortic Balloon Catheters and Accessories	Datascope Corp.	DSP	Class II	2013-12-12
K132862	Healthpro Professional Blood Glucose Monitoring System	Infopia Co, Ltd.	NBW	Class II	2013-12-12
K132803	Medapps 2.0 Remote Patient Monitoring System, Healthpal, Healthcom, Mobile Link	Medapps Inc., dba Alere Connect	DRG	Class II	2013-12-12
K132754	Neogen Psr System	Energist Limited	GEI	Class II	2013-12-12
K132558	Sync-Rx System	Volcano Corporation	OWB	Class II	2013-12-12
K132523	Myoperfusion	Toshibamedical Systems Corporation	JAK	Class II	2013-12-12
K132177	Medcomp Gen III Power Injectable Port	Medcomp ( Medical Components)	LJT	Class II	2013-12-12
K132120	Wtf Secura Syringe and Needle	Beijing Wantefu Medical Apparatus Co., Ltd.	FMF	Class II	2013-12-12
K131766	Platinum Drf Imaging System	Apelem-Dms Group	JAA	Class II	2013-12-12
K130439	External Counterpulsation Device with Sp02 Mornitoring	Chongqing Psk Sci-Tech Development Co., Ltd.	DRN	Class II	2013-12-12
K123861	Aidi Dental Implant System	Aidi Biomedical, LLC	DZE	Class II	2013-12-12
K133687	Thd N-Ano Anoscope	Thd SpA	FER	Class II	2013-12-11
K133180	Erbe Esu Model Vio Dv with Accessories	Erbe USA Inc	GEI	Class II	2013-12-11
K133094	Certex Oct Spinal Implant System	Xtant Medical Holdings, Inc.	KWP	Class II	2013-12-11
K132897	Clydesdale Spinal System	Medtronic Sofamor Danek	MAX	Class II	2013-12-11
K132873	Vanguard Xp Knee System	Zimmer GmbH	MBH	Class II	2013-12-11
K132773	Sidexis 4	Sirona Dental Systems GmbH	LLZ	Class II	2013-12-11
K132028	Ulthera System	Merz North America, Inc.	OHV	Class II	2013-12-11
K131649	Me	Syneron Beauty	ONF	Class II	2013-12-11
K131596	Wound Measuring & Monitoring Device	WoundVision, LLC	FXN	Class I	2013-12-11
K130758	Kronner Side-Kick Uterine Manipulator Holder	Kronner Prototypes, Inc.	LKF	Class II	2013-12-11
K130708	Smith & Nephew Patient Matched Cutting Blocks	Smith & Nephew, Inc.	JWH	Class II	2013-12-11
K130317	Genesys Spine Apache Ibfd Star Cervical System	Genesys Spine	ODP	Class II	2013-12-11
K123728	Retrieval Bag	Flexbar Machine Corp.	GCJ	Class II	2013-12-11
K122834	Polysite Implantable Infusion Ports	Perouse Medical	LJT	Class II	2013-12-11
K121873	Avinent Dental Implant System	Avinent Implant System S.L.	DZE	Class II	2013-12-11
K133474	Biosign Flu a + B, Status Flu a & B	Princeton BioMeditech Corp.	PSZ	Class II	2013-12-10
K133039	Restoris Multicompartmental Knee System	Mako Surgical Corp.	NPJ	Class II	2013-12-10
K131586	Canary Breathing System	Palo Alto Health Sciences, Inc.	HCC	Class II	2013-12-10
K123248	CPR Rsq Assist	Avantech, Inc.	LIX	Class II	2013-12-10
K122393	Tg-Body Mi&body S-Trainer	Miga Medical Co., Ltd.	NGX	Class II	2013-12-10
K133289	Precice Intramedullary Limb Lengthening System	Ellipse Technologies, Inc.	HSB	Class II	2013-12-09
K133126	K7 Lumbar Spacers	K7, LLC	MAX	Class II	2013-12-09
K133016	Vent-Os Sinus Dilation System	Sinusys Corporation	LRC	Class I	2013-12-09
K132783	Exoshape Duo Soft Tissue Fastener	Medshape, Inc.	MBI	Class II	2013-12-09
K132775	Ponto Plus and Ponto Plus Power	Oticon Medical AB	LXB	Class II	2013-12-09
K132532	Syngo.plaza Vb10a	Siemens AG Healthcare	LLZ	Class II	2013-12-09