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 938 of 3530

510(k) clearances, page 938 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K111266	Easylock Osteosystem	Trimed Inc	HRS	Class II	2011-10-06
K110579	Architect B12 Reagents, Architect B12 Calibrators, and Architect B12 Controls	Abbott Medical	CDD	Class II	2011-10-06
K110531	Endoflip Ecd	Crospon, Ltd.	FED	Class II	2011-10-06
K103643	Ascot Home Medical Monitoring System (Hmms)	Ascot Technologies, Inc.	DRG	Class II	2011-10-06
K103625	Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic Device	Draeger Medical Systems, Inc.	CBK	Class II	2011-10-06
K103485	Senograph Ds, Senograph Essenstial	General Electric Co.	MUE	Class II	2011-10-06
K101592	Erase Hand- Held Controller; Erase Single Use Electric Catridge System	Cheng Medical, Corporation	GXD	Class II	2011-10-06
K112715	Candela Gentlemax Family of Lasers	Candela Corporation	GEX	Class II	2011-10-05
K112173	Speacelabs Multigas Module	GE Healthcare	CBR	Class II	2011-10-05
K112007	Carto 3 Ep Navigation System, Version 2.2	Biosense Webster Inc	DQK	Class II	2011-10-05
K111848	Exeter X3 Rimfit Acetabular Cup	Stryker Corp.	JDI	Class II	2011-10-05
K111740	Ameriwater Mro Portable Reverse Osmosis System - Single Patient, 1 to 3 Station	AmeriWater LLC.	FIP	Class II	2011-10-05
K111447	Zimmer Periarticular Screws	Zimmer GmbH	HWC	Class II	2011-10-05
K110819	Singhmed Roolip Manipulator	J.Singh Instruments	HEW	Class II	2011-10-05
K112703	Shaker Digital Thermometer	Measure Technology Co., Ltd.	FLL	Class II	2011-10-04
K112456	Adapt(tm) Universal Balloon Open Access Port	Teleflexmedical, Inc.	GCJ	Class II	2011-10-04
K112116	Digital Clinical Thermometer Model V901us	Amperor-Electronic(Sz) Co., Ltd.	FLL	Class II	2011-10-04
K111905	Intellivue Guardian Software Model 866009, Intellivue Cl Sp02 Pod Model 865215, Intellivue Cl Nbp Pod Model 865216	Philips Medizinsysteme Boeblingen GmbH, Cardiac an	DXJ	Class II	2011-10-04
K111662	Venotrain Curaflow	Bauerfeind AG	DWL	Class II	2011-10-04
K111583	Flaatz 560	DRTECH Corporation	MQB	Class II	2011-10-04
K111551	Oec(r) 9800, Oec(r) 9800 Plus	GE Healthcare	OWB	Class II	2011-10-04
K111378	Oximetry Interface Kit	Respironics, Inc.	MNS	Class II	2011-10-04
K111206	Teco Diagnostics Saliva Alcohol Test	Teco Diagnostics	DIC	Class II	2011-10-04
K110870	Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System	Toshiba America Medical Systems, In.C	IYN	Class II	2011-10-04
K110063	Sovereign Spinal System	Medtronic Sofamor Danek	OVD	Class II	2011-10-04
K103651	Cardiomed	Cardio Medical Products, Inc.	LDD	Class II	2011-10-04
K103487	Fora Pnc100 Digital Pregancy Test, Td-5301 Pregancy Test	Taidoc Technology Corporation	LCX	Class II	2011-10-04
K112228	Vitek 2 Streptococcus Levofloxacin	bioMerieux, Inc.	LON	Class II	2011-10-03
K111899	Armada 35/35Ll Pta Catheter	Abbott Vascular	LIT	Class II	2011-10-03
K111735	Reverse Shoulder Prosthesis Monoblock Hemi Adapter	Encore Medical, LP	PHX	Class II	2011-10-03
K111644	Mobicath Transseptal Needle	Great Batch Medical	DRC	Class II	2011-10-03
K111606	Pinnacle Precision Access System	Terumo Medical Corp.	DYB	Class II	2011-10-03
K111357	Straumann Narrow Neck Crossfit (Nnc) 03.3Mm Dental Implant System	Straumann USA, LLC	DZE	Class II	2011-10-03
K111169	Protraction Face Mask, Reverse Pull Face Mask Model Km-Pvs, Km-Pis, Km-Pvm, Km-Pim, Model Km-Fms, Km-Fml, Km-Fmf	Kwang Myung Daicom Ltd.	DZB	Class II	2011-10-03
K110672	Etwo Skin Treatment System	Syneron, Ltd.	GEI	Class II	2011-10-03
K110318	Excellagen	Tissue Repair Company	KGN	Unclassified	2011-10-03
K110308	Prosthetic System	OSSTEM Implant Co., Ltd.	NHA	Class II	2011-10-03
K103675	Chienmax Vietnam Co. Ltd Powder Free Blue Nitrile Examination Glove	Chienmax Vietnam Co., Ltd.	LZA	Class I	2011-10-03
K102871	Silver Care Anitbacterial Toothbrush	Piave Spazzolificio S.p.A.	EFW	Class I	2011-10-03
K112738	Andon Health Care Management System Software	Andon Medical co., Ltd	NBW	Class II	2011-09-30
K112609	Desara Mesh	Caldera Medical, Inc.	OTN	Class II	2011-09-30
K112530	3Di Including Cscore	Shina Systems Ltd.	LLZ	Class II	2011-09-30
K112442	Radial-Emitting Shaped Fiber Optic Delivery System	Biolitec Medical Devices, Inc.	GEX	Class II	2011-09-30
K112320	Full Automatic (Nibp) Blood Pressure Monitor	Health & Life Corporation	DXN	Class II	2011-09-30
K112293	Hts Extremity Coil, Hts Surface Coil	Time Medical Systems, Inc.	MOS	Class II	2011-09-30
K112096	Imagelink	Computer Programs and Systems, Inc.	LLZ	Class II	2011-09-30
K111865	Wired/ Wireless Fdr D-Evo with X-Ray Detection Feature	FUJIFILM Healthcare Americas Corporation	MQB	Class II	2011-09-30
K111676	Apex	Elekta Limited	IXI	Class II	2011-09-30
K111412	Surgisteer Scissors, Surgisteer Dissector / Grasper, Surgisteer Hook	Steerable Technologix	GEI	Class II	2011-09-30
K111366	Bd Nexiva Diffusics Closed IV Catheter System	Becton, Dickinson & Company (BD)	FOZ	Class II	2011-09-30