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 905 of 3530

510(k) clearances, page 905 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K113593	Nextgen Altius Oct System	Biomet Spine (Aka Ebi, LLC)	KWP	Class II	2012-04-17
K113424	Lofric Single Use Urinary Catheter	Astra Tech, Inc.	EZD	Class II	2012-04-17
K112928	Rs Safe White Nitrile Medical Examination Gloves Powder Free or Other Proprietary Name	Riverstone Resources Sdn Bhd	LZA	Class I	2012-04-17
K112305	Vigor a Low Speed Air Motor, Vigor C Low Speed Contra-Angle Handpieces, Vigor S Low Speed Straight Handpieces	Thunder Tiger Corp.	EGS	Class I	2012-04-17
K111999	Healgen 11 Reagent Strip for Urinalysis, Healgen 10 Reagent Strip for Urinalysis, and Healgen 4 Reagent Strip for Urinal	Healgen Scientific LLC	JIO	Class II	2012-04-17
K110840	Liac	Sordina S.p.A.	IYE	Class II	2012-04-17
K103037	Ind Urinary Tract Infection (Uti) Test Strips	Ind Diagnostic, Inc.	NGJ	Class I	2012-04-17
K120830	Navigator Delivery System (Navigator Ds)	Carticept Medical, Inc.	FRN	Class II	2012-04-16
K120403	Spider Flexible Blunt Dissector and Band Passer	Asensus Surgical, Inc.	GCJ	Class II	2012-04-16
K120291	Op Spine System	Orthopediatrics Corp	OSH	Class II	2012-04-16
K120117	Codman Quad-Lock Sterilization Container System	Cerenovus, Inc.	KCT	Class II	2012-04-16
K113802	Escalate Laminoplasty System	Howmedica Osteonics Corp	NQW	Class II	2012-04-16
K113352	Transcorp Spinal Access System	Transcorp	HRX	Class II	2012-04-16
K112290	Supercath Z3v	Togo Medikit Co., Ltd.	FOZ	Class II	2012-04-16
K103767	Dual Heated Infant Vreathing Cirouits	Fisher & Paykel Healthcare, Inc.	BZE	Class II	2012-04-16
K120972	Flexitouch System	Tactile Systems Technology Inc	JOW	Class II	2012-04-13
K120805	Proteus Pta Balloon Catheter with Embolic Capture Feature	Angioslide, Ltd.	LIT	Class II	2012-04-13
K120794	Ascend Shoulder System	TORNIER Inc.	KWS	Class II	2012-04-13
K120703	Zonare Zs3 Diagnostic Unltrasound System	Zonare Medical Systems, Inc.	IYN	Class II	2012-04-13
K120331	Syngo CT Dynamic Angio	Siemens AG Medical Solutions	JAK	Class II	2012-04-13
K120315	Syngo.mr Spectro Engine, Syngo.mr Spectro Svs, Syngo.mr Spectro Csi, Syngo.mr Spectro Extension	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2012-04-13
K120300	CT-Guide Needle Guidance System	Activiews, Ltd.	JAK	Class II	2012-04-13
K120292	Caplox II Pedicle Screw System	CAPTIVA SPINE, Inc.	MNI	Class II	2012-04-13
K120161	Alphapoint Imaging Software	Radlogics, Inc.	LLZ	Class II	2012-04-13
K120135	2D Cardiac Performance Analysis Mr 1.0	TOMTEC Imaging Systems GmbH	LLZ	Class II	2012-04-13
K120092	Plymouth Thoracolumbar Plate System	Globus Medical, Inc.	KWQ	Class II	2012-04-13
K120062	Drx-Revolution Mobile X-Ray System	Eastman Kodak Company	IZL	Class II	2012-04-13
K120032	Mechanical Wheelchair	Aikin Healthcare Co., Ltd	IOR	Class I	2012-04-13
K113096	Micro I	Carefusion Germany 234 GmbH	BZG	Class II	2012-04-13
K112717	Nuvasive Nvjjb System	NuVasive Inc	ETN	Class II	2012-04-13
K112141	Smartepil,depilase Yag Lase Plus	Castle Laser Systems, Limited	GEX	Class II	2012-04-13
K110590	Intrabeam Needle Applicator	Carl Zeiss Surgical GmbH	JAD	Class II	2012-04-13
K102327	Clearvision Dr 7000F	JPI Healthcare Co., Ltd	MQB	Class II	2012-04-13
K120209	Patient Controlled Analgesia (Pca) Button Cable	American I.V. Products, Inc.	MRZ	Class II	2012-04-12
K113839	Retract Gingival Retraction/hemostatic Paste	Parkell, Inc.	MVL	Unclassified	2012-04-12
K113768	U-Right Td-4280 Blood Glucose Monitoring System	Taidoc Technology Corporation	LFR	Class II	2012-04-12
K113583	Curad Antibacterial Bandage	MEDLINE INDUSTRIES, LP - Northfield	FRO	Unclassified	2012-04-12
K113186	Sterile Insulin Pen Needle	Shina Corp.	FMI	Class II	2012-04-12
K112398	Triv(tm) Valved Tearaway Introducer, Tirv(tm) Valved Tearaway Introducer with Side Port	Galt Medical Corp	DYB	Class II	2012-04-12
K112215	Hemcon Hemostatic Gel	Hemcon Medical Technologies Europe, Ltd.	QSY	Unclassified	2012-04-12
K111547	Bili-Therapy Pad Type	Atom Medical Corporation	LBI	Class II	2012-04-12
K111050	Esophageal / Rectal Temperature Probe, 9Fr, 12Fr, Esophageal Stethoscope with Temperature Sensor, 9Fr, 12Fr, 18Fr, 24Fr	Starboard Medical, Inc.	BZT	Class II	2012-04-12
K110333	Naturalase CO2 Laser System	Focus Medical, LLC.	ONG	Class II	2012-04-12
K120264	Konan Specular Microscope Xiv	Konan Medical, Inc.	NQE	Class II	2012-04-11
K120252	Raumedic-Icp-Temp-Monitoring-System	Raumedic AG	GWM	Class II	2012-04-11
K113847	Borrelia Burgdorferi Igg Blot Test	Gold Standard Diagnostics, LLC	LSR	Class II	2012-04-11
K113533	Neuro Check Device with Io-Flex Wire	Baxano, Inc.	HAE	Class II	2012-04-11
K112438	Titan Modular Total Shoulder System	Ascension Orthopedic	KWS	Class II	2012-04-11
K112073	Infusite Needleless Acces Device (Sterile, Bulk Non-Sterile) and Infusite Needleless Access Device 'Y' Adapter (Bulk...	Rx Devices, LLC	FPA	Class II	2012-04-11
K103227	Oratect Oral Fluid Drug Screen Devices	Branan Medical Corp.	DIO	Class II	2012-04-11