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 1024 of 3531

510(k) clearances, page 1024 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K100187	Easyra Glu-T Reagent, Easyra Glu-H Reagent	Medica Corp.	CGA	Class II	2010-05-05
K100180	Surgiquest Anchorport Sil Kit	Surgiquest, Inc.	GCJ	Class II	2010-05-05
K094005	Fora G31a/td-4256A Blood Glucose Monitoring System and Fora G31b/td-4256B Blood Glucose Monitoring System	Taidoc Technology Corporation	NBW	Class II	2010-05-05
K092302	Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color	Bettercare Plastic Products Co., Ltd.	LYZ	Class I	2010-05-05
K100614	Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates	Blackstone Medical, Inc.	KWQ	Class II	2010-05-04
K100523	Adult Cerebral-Somatic Oximetry Sensor, Pediatric Cerebral-Somatic Oximetry Sensor Model Hhs-Safb-Sm, Hhs-Spfb-USA	Hygia Health Services, Inc.	NMD	Class II	2010-05-04
K100423	Dermabond Nx Adhesive Model: Dnx6, Dnx12	Ethicon, Inc	MPN	Class II	2010-05-04
K100341	Spermcheck Fertility	Princeton BioMeditech Corp.	POV	Class II	2010-05-04
K100325	Peri-Loc Locking Hole Inserts and Cable Accessories	Smith & Nephew, Inc.	HWC	Class II	2010-05-04
K100306	Kendall Scd Sequential Compression Comfort Sleeves	Medtronic, Inc.	JOW	Class II	2010-05-04
K100139	Safe Life N95 Respirator and Surgical Mask, Models B130 and B150	Safelife Corp.	MSH	Class II	2010-05-04
K100019	Pascal Streamline Photocoagulator	OptiMedica Corp.	HQF	Class II	2010-05-04
K093737	Hemosil F11 & Fv DNA Control	Instrumentation Laboratory Co.	NZB	Class II	2010-05-04
K093886	Engstrom Carestation, Engstrom Pro	Datex-Ohmeda Inc., A Division of Instrumentarium C	CBK	Class II	2010-05-03
K101041	Dc-7 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	ITX	Class II	2010-04-30
K100994	Preloaded Tissue Marker Device	Carbon Medical Technologies, Inc.	NEU	Class II	2010-04-30
K100939	Intellivue Patient Monitor Model: Mp2, Mp5, Mp5t, Mp20, Mp30, Mp40, Mp50, Mp60, Mp70, Mp75, Mp80 and Mp90	Philips Medizinsysteme Boeblingen GmbH, Cardiac an	MHX	Class II	2010-04-30
K100930	Primewire Prestiage Pressure Guide Wire, Models 8185, 8185J, 8300, 8300J	Volcano Corporation	DQX	Class II	2010-04-30
K100921	Admiral Xtreme Pta Balloon Dilatation Catheter	Invatec S.p.A.	LIT	Class II	2010-04-30
K100915	Inspectra Sto2 Tissue Oxygenation Monitor, Model 650	Hutchinson Technology, Inc.	MUD	Class II	2010-04-30
K100733	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Rayen Safety Products Limited	LYZ	Class I	2010-04-30
K100723	Disposable Circular Stapler, Disposable Circular Stapler Model Kygw-25.5, Kygw-28.5	Changzhou Kangdi Medical Stapler Co., Ltd.	GDW	Class II	2010-04-30
K100475	Axsos Locked Plating System Line Extension of 5Mm Locking Inserts	Howmedica Osteonics Corp	HRS	Class II	2010-04-30
K100436	Clickfine Pen Needle	Ypsomed AG	FMI	Class II	2010-04-30
K100347	Optibond Se	Sybron Dental Specialties, Inc.	KLE	Class II	2010-04-30
K100292	Caas Qva 3D, Caas Qca 3D	PIE Medical Imaging B.V.	LLZ	Class II	2010-04-30
K100278	Quadrox-Id Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Models Be-Hmod 30000-USA, Beq-Hmod 30000-USA	MAQUET CARDIOPULMONARY GmbH	DTZ	Class II	2010-04-30
K100093	Vsi Torque Device	Vascular Solutions LLC	DQX	Class II	2010-04-30
K100012	Gryphon T Br Ds Anchor W/orthocord, Gryphon T Br Anchor W /Orthocord, Gryphon P Br Ds Anchor W/orthocord, Gryphon P Br a	DePuy Mitek, Inc.	MAI	Class II	2010-04-30
K094064	Iluma Vision Model Version 2.2	3M Imtec	LLZ	Class II	2010-04-30
K093857	C7 Xr Imaging System with C7 Dragonfly Imaging Catheter and Disposable Accessories	Lightlab Imaging, Inc.	NQQ	Class II	2010-04-30
K093263	Stretch Vinyl Examination Glove, Powder Free, Yellow/white	Qingdao Lang Hui Import & Export Co., Ltd.	LYZ	Class I	2010-04-30
K093235	Ringloc + Hybrid Acetabular System	Zimmer GmbH	KWA	Class III	2010-04-30
K092969	H/s Catheter Set 5 French, Model 61-5005F, H/s Catheter Set 7 French, Model 61-5007F	Sterling Medical, Inc.	LKF	Class II	2010-04-30
K092554	Blastomere Biopsy Pipettes, Polar Body Biopsy Pipettes	Sunlight Medical, Inc.	MQH	Class II	2010-04-30
K092033	Vibrolith and Vibrolith Plus Intracorporeal Lithotriptor	Elmed USA	FFK	Class II	2010-04-30
K091958	Belfort-Dildy Obstetric Tamponade System	Glenveigh Surgical, LLC	OQY	Class II	2010-04-30
K091797	Tsrh Spinal System	Medtronic Sofamor Danek	NKB	Class II	2010-04-30
DEN090005	Prineo Skin Closure System	Closure Medical Corp.	OMD	Class II	2010-04-30
K100517	Instrumed Forceps Obsterical, Model# 46-5Xxx, Ob-Xxxx	Instrumed International Inc dba Avalign German Specialty Instruments	HDA	Class II	2010-04-29
K100301	Opal Bond Flow	Ultradent Products Inc.	DYH	Class II	2010-04-29
K100266	Actiwave 1E, Actiwave2e, Actiwave2m, Actiwave4e, Actiwave Cardio Model 08-514, 08-521, 08-536, 08-557, 08-603	Camntech	MWJ	Class II	2010-04-29
K093899	Mammotome Biopsy System for Molecular Imaging	Ethicon Endo-Surgery Inc	KNW	Class II	2010-04-29
K093728	Be Micro, Trea	EB Neuro S.p.A.	OLV	Class II	2010-04-29
K093422	Vital Sync Model 5000 Series	Somanetics Corp.	MWI	Class II	2010-04-29
K093017	Stellar 300	Larsen & Toubro Limited	MWI	Class II	2010-04-29
K091486	K-Assay Microalbumin and K-Assay Microalbumin Calibrator	Kamiya Biomedical Company, LLC	DCF	Class II	2010-04-29
K090510	Doppler Fetal Heartbeat Rate Detector	Shenzhen Bestman Instrument Co.,Ltd	KNG	Class II	2010-04-29
K100866	Profemur Hip System Modular Necks	Wrightmedicaltechnologyinc	LZO	Class II	2010-04-28
K100710	Roll-X Guidewire	Abbott Medical	DQX	Class II	2010-04-28