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 1034 of 3531

510(k) clearances, page 1034 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K092905	Autostart Burette	Analytica, Ltd.	FPA	Class II	2010-03-04
K092857	Vericore Abutment in Titanium for Implant Systems	Whip-Mix Corp.	NHA	Class II	2010-03-04
K092366	Tts100 Portable Hyperthermic Perfusion Device	Thermal Therapeutic Systems, Inc.	LGZ	Class II	2010-03-04
K092148	Hamilton-C2	Hamilton Medical AG	CBK	Class II	2010-03-04
K091732	Vrlxp, Model Xp	Deep Breeze, Ltd.	OCR	Class II	2010-03-04
K083186	Aesculap Hydrolift Vbr System	Aesculap Implant System, Inc.	MQP	Class II	2010-03-04
K100468	Zeiss Infrared 800 with Flow 800 Option	Carl Zeiss Surgical GmbH	IZI	Class II	2010-03-03
K100413	Temp It	Spident Co., Ltd.	EBF	Class II	2010-03-03
K093894	Anthogyr Impulsion Implantology Contra-Angle	Anthogyr	EFA	Class I	2010-03-03
K093812	Acuson S2000 Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	IYN	Class II	2010-03-03
K093757	Md300c1 Fingertip Pulse Oximeter	Beijing Choice Electronic Technololgy Co., Ltd.	DQA	Class II	2010-03-03
K093594	Modification to Relieva Stratus Microflow Spacer	Acclarent Inc	KAM	Class I	2010-03-03
K093559	Vintage Mp	Shofu Dental Corp.	EIH	Class II	2010-03-03
K093273	Vit Kit - Freeze and Thaw	FUJIFILM Biosciences Inc.	MQL	Class II	2010-03-03
K093258	Blom-Singer Indwelling Tep Occluder	Freudenberg Medical, LLC	EWL	Class II	2010-03-03
K093194	Mgb Disposable Retrieval Bag Lapbag	Mgb Endoskopische Gerate GmbH (Berlin)	GCJ	Class II	2010-03-03
K092675	Grindcare	Medotech A/S	HCC	Class II	2010-03-03
K092613	Color Lcd Monitor, Model Radiforce Rs210	Eizo Nanao Corporation	LLZ	Class II	2010-03-03
K092331	Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;	Encore Medical, LP	KWA	Class III	2010-03-03
K091208	Gs III System	OSSTEM Implant Co., Ltd.	DZE	Class II	2010-03-03
K090658	Synthes External Fixation Devices, Mr Conditional	Synthes (USA) Products LLC	KTT	Class II	2010-03-03
K093764	Solov2 Blood Glucose Monitoring System	Biotest Medical Corp.	NBW	Class II	2010-03-02
K093717	C-Mor Visualization Device	Axis Surgical Technologies, Inc.	HRX	Class II	2010-03-02
K093126	Anapnoguard Endotracheal Tube	Hospitech Respiration	BTP	Class I	2010-03-02
K092902	U-Right Td-4238 and Td-4246 Blood Glucose Monitoring System Fora G31 Blood Glucose Monitoring System, Td-4256 Blood Gluc	Taidoc Technology Corporation	NBW	Class II	2010-03-02
K091967	Medacta Bipolar Head	Medacta International SA	KWY	Class II	2010-03-02
K091688	A-Grix Resorbable Bone Void Filler	Ag Digital Technology Corp.	MQV	Class II	2010-03-02
K091025	Chromid Vre Agar, Model: Ref 43 851	bioMerieux, Inc.	JSO	Class II	2010-03-02
K100386	Disposable Circular Stapler, Models Why-25, Why-29. Why 32	Changzhou Waston Medical Appliance Co., Ltd.	GDW	Class II	2010-03-01
K100079	Digital Ultrasound Scanner	Shenzhen Well.D Medical Electronics Co., Ltd.	IYO	Class II	2010-03-01
K093719	Pro-Fix Precision Fixation System Model Pfm#, Pfb#, Pft#	Osteogenics Biomedical, Inc.	DZL	Class II	2010-03-01
K093414	Port-a-Cath Power P.a.c. Implantable Venous Access Systems	Abbott Medical	LJT	Class II	2010-03-01
K093155	Vashe Wound Cleansing System	Puricore, Inc.	FRO	Unclassified	2010-03-01
K092842	Echoplaque	Indec Systems, Inc.	LLZ	Class II	2010-03-01
K092494	Gel Filled Gum Soother	Luv N' Care Ltd	KKO	Class II	2010-03-01
K092244	Ma61, Ma62, Ma63 Family of Portable Audiometers	Diagnostic Group LLC	EWO	Class II	2010-03-01
K091634	Nmi Fc	Boston Scientific Corporation	DTL	Class II	2010-03-01
K082823	Hevylite Human Iga Kappa and Iga Lambda Bn Kits	The Binding Site Group Ltd.	CFN	Class II	2010-03-01
K100282	Terumo Surshield- Pur Safety i.v. Catheter	Terumo Corp.	FOZ	Class II	2010-02-26
K100075	Powder-Free Vinyl Patient Examination Gloves, Colored (White)	Tangshan Jiteng Plastic Products Co., Ltd.	LYZ	Class I	2010-02-26
K100074	Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)	Tangshan Jiteng Plastic Products Co., Ltd.	LYZ	Class I	2010-02-26
K093796	Asept Peritoneal Drainage System	PFM Medical GmbH	PNG	Class II	2010-02-26
K093684	Easycare Online	ResMed Corp	BZD	Class II	2010-02-26
K093463	Avamax Vertebral Balloon Model Vbs1010, Vbs1015, Vbs1020	Care Fusion	NDN	Class II	2010-02-26
K093209	Focus ( Tm) Echogenic Nerve Stimulating Needle	Cook Inc.	BSP	Class II	2010-02-26
K093203	Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models 60831, 60832, 60841	Medtronic, Inc.	GEI	Class II	2010-02-26
K093174	Spiropalm	Cosmed S.r.l.	BZG	Class II	2010-02-26
K092965	Trailrunner Guidewires	Lake Region Mfg., Inc.	DQX	Class II	2010-02-26
K092947	Telesentry, Model Ts01	Scottcare Corporation	DSI	Class II	2010-02-26
K092733	Pyton	Arm Medical Devices, Inc.	BSK	Class II	2010-02-26