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 831 of 3530

510(k) clearances, page 831 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K131131	E.g. Scan(tm) II Esophagoscope System	IntroMedic Co., Ltd.	EOX	Class II	2013-06-21
K130914	Filmarray Blood Culture Identification (Bcid) Panel	BioFire Diagnostics, LLC	PEN	Class II	2013-06-21
K130833	Dp-20 Digital Ultrasonic Diagnostic Imaging System; Dp-30 Digital Ultrasonic Diagnostic Imaging System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2013-06-21
K130816	Interx Sterile Self-Adhesive Dual Electrode (Issde)	InterX Technologies	GXY	Class II	2013-06-21
K130664	Hyrdromax Hmef	A-M Systems	CAH	Class II	2013-06-21
K130310	Certain Bellatek Provisional Abutments	ZimVie US Corp LLC	NHA	Class II	2013-06-21
K130295	Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional Lipid Profile and Glucose Measuring System.	Infopia Co, Ltd.	NBW	Class II	2013-06-21
K130281	Oak Ridge Products Sharp Container	Oak Ridge Products	MMK	Class II	2013-06-21
K130099	Taperfill Femoral Hip Stem 425-31-005_017 425-41-005_019	Encore Medical, LP	LPH	Class II	2013-06-21
K124038	Bedside Paediatric Early Warning System (Bedsidepews)	Bedside Clinical Systems, Inc.	MWI	Class II	2013-06-21
K123158	Ion Magnum Genius	Ion Genius, Inc.	NGX	Class II	2013-06-21
K122957	Tezo Titanium Cage Family	Ulrich GmbH & Co. KG	MAX	Class II	2013-06-21
K120727	Mfm-Cms Central Monitoring System	Edan Instruments, Inc.	MHX	Class II	2013-06-21
K131543	Tampax(r) L Plastic Tampons, Unscented	Procter & Gamble Co.	HEB	Class II	2013-06-20
K130894	Xpert Mrsa/sa Blood Culture Assay; Genexpert Dx Systems (Gx-I, Gx-II, Gx-IV, Gx-Xvi); Genexpert Infinity-48 System; Gene	Cepheid	NQX	Class II	2013-06-20
K130877	Expedium Spine System	Medos International SARL	NKB	Class II	2013-06-20
K130795	Titan	Interacoustics a/S	EWO	Class II	2013-06-20
K130794	Celltracks Analyzer II System	Veridex, LLC	NQI	Class II	2013-06-20
K130722	Aircast Venaflow Elite System	DJO, LLC	JOW	Class II	2013-06-20
K130486	Futurabond Universal	Voco GmbH	KLE	Class II	2013-06-20
K130397	Arrow Gpscath Balloon Dilatation Catheter	Hotspur Technologies	LIT	Class II	2013-06-20
K130279	Reform Pedicle Screw System	Spinal USA	MNI	Class II	2013-06-20
K130217	Orthopediatrics Acl Reconstructive System	Orthopediatrics Corp	MBI	Class II	2013-06-20
K123106	Digital Diagnostic X-Ray System Model Xgeo Gu60a	Samsung Electronics Co., Ltd.	KPR	Class II	2013-06-20
K122763	Physiological Data Processor	Zephyr Technology Corporation	DRG	Class II	2013-06-20
K121101	Spotcheck Neonatal Total Galactose Microplate Reagent Kit	Astoria-Pacific, Inc.	JIA	Class I	2013-06-20
K112598	American Surgical Company/ Neurosurgical Sponges (Brand)	American Surgical Company, LLC	HBA	Class II	2013-06-20
K131443	Coalign Innovations Acculif Xl Ibf Cage	Coalign Innovations, Inc.	MAX	Class II	2013-06-19
K131395	Transtek Blood Pressure Monitor	Guangdong Transtek Medical Electronics Co.,Ltd	DXN	Class II	2013-06-19
K131267	Voluson E6/e8/e8expert/e8expert Limited Edition/e10	GE Healthcare	IYN	Class II	2013-06-19
K130819	Cll- V1 Light Source	Olympus Winter & Ibe GmbH	NTN	Class II	2013-06-19
K130774	Universal Distal Radius System	Newclip Technics	HRS	Class II	2013-06-19
K130695	Z5 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2013-06-19
K130566	Basixtouch	Merit Medical Systems, Inc.	MAV	Class II	2013-06-19
K130564	Full Automatic (Nibp) Blood Pressure Monitor	Health & Life Corporation	DXN	Class II	2013-06-19
K130337	Randox Speciality Control (I) Levels 1, 2 and 3	Randox Laboratories, Limited	JJY	Class I	2013-06-19
K123007	Veri-Q Mgd-1001 Blood Glucose Monitoring System, Veri-Q Plus Mgd-1001 Blood Glucose Monitoring System	Mico Biomed Co., Ltd.	NBW	Class II	2013-06-19
K122567	Joule 810/940/980 Multi-Platform System	Sciton, Inc.	GEX	Class II	2013-06-19
K121045	Human Albumin Csf Kit	The Binding Site Group Ltd.	DCF	Class II	2013-06-19
K131445	Osteomed Extremilock Foot Plating System	Osteomed	HRS	Class II	2013-06-18
K131193	Actitouch Act-Adaptive Compression Therapy System	Tactile Systems Technology Inc	JOW	Class II	2013-06-18
K131153	Evenflo Advanced Double Electric Breast Pump	Evenflo Feeding Incorporated	HGX	Class II	2013-06-18
K130927	Durablue Sterilization Wrap	Cardinal Health200, LLC	FRG	Class II	2013-06-18
K130563	Full Automatic (Nibp) Blood Pressure Monitor	Health & Life Corporation	DXN	Class II	2013-06-18
K130545	Multi Lead Trial Cable	Abbott Medical	GZB	Class II	2013-06-18
K130499	Iu22 Diagnostic Ultrasound System	Philips North America LLC	IYN	Class II	2013-06-18
K130298	Biopro Kwick-Wire Universal Screw System	Biopro, Inc.	JDW	Class II	2013-06-18
K130050	Titan Reverse Shoulder System	Ascension Orthopedic	KWS	Class II	2013-06-18
K123253	Ids Isys 1,25 Dihydroxy Vitamin D, Ids-Isys, 1,25 Dihydroxy Vitamin D Control Set, and Ids Isys 1,25 Dihydroxy Vitamin D	Immunodiagnostic Systems Ltd.	MRG	Class II	2013-06-18
K123144	Vivo 50	GE Healthcare, Breas Medical AB	NOU	Class II	2013-06-18