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 948 of 3531

510(k) clearances, page 948 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K111807	Medline Powder-Free Latex Surgical Gloves, Sterile, W/ or W/o Aloe Vera, with Protein Content Labeling Claim...	MEDLINE INDUSTRIES, LP - Northfield	KGO	Class I	2011-08-18
K111429	Sensititre (R) Hp Mic Susceptibility Plate with Cefaroline (0.004-8Ug/ml) and the Sensititre (R) 18-24 Hour Mic Susce...	Trek Diagnostic Systems, Ltd.	JWY	Class II	2011-08-18
K111167	Xtender Film Processor, Sprint Film Processor Model Xtender Model Sprint	Velopex International, Inc.	IXW	Class II	2011-08-18
K111106	Truebeam	Varian Medical Systems, Inc.	IYE	Class II	2011-08-18
K110882	Imc Insulin Syringe	Intl. Medsurg Connection, Inc.	FMF	Class II	2011-08-18
K110656	Imc Blood Collection Needle	Intl. Medsurg Connection, Inc.	FMI	Class II	2011-08-18
K110598	Smr Reverse Shoulder System	Lima Corporate S.p.A.	PHX	Class II	2011-08-18
K110296	Axis-Shield Anti-Ccp	Axis-Shield Diagnostics, Ltd.	NHX	Class II	2011-08-18
K110076	Reprocessed 3D Diagnostic Ultrasound Catheter	Sterilmed Inc	OWQ	Class II	2011-08-18
K103790	Ace Trimark Tricam Dental Implant	Ace Surgical Supply Co., Inc.	DZE	Class II	2011-08-18
K103673	Giardia/ Cryptosporidium Quik Chek	Techlab Inc., Corporate Research Center	MHI	Class II	2011-08-18
K103659	Cs 9300, Cs 9300C	Trophy	OAS	Class II	2011-08-18
K103274	Sentinelle Endo Coil Array for Pelvic Imaging	Sentinelle Medical, Inc.	MOS	Class II	2011-08-18
K102394	Amsco V-Pro 1 Low Temperature Sterilization System; Amsco V-Pro 1 Plus Low Temperature Sterilization System	STERIS Corporation	MLR	Class II	2011-08-18
K112308	Crosser Recanalization System	C.R. Bard Inc	PDU	Class II	2011-08-17
K112281	Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx, 6100Cb-Xxxx	Trireme Medical, Inc.	DQY	Class II	2011-08-17
K111987	Fibernet Embolic Protection Device	Lumen Biomedical, Inc.	NTE	Class II	2011-08-17
K111900	Nextstep Antegrade Chronic Hemodialysis Catheter	Teleflexmedical, Inc.	MSD	Class II	2011-08-17
K111881	Virtue Male Sling System and Alexis(r) Wound Retractor Kit	MEDLINE INDUSTRIES, LP - Northfield	OTM	Class II	2011-08-17
K111594	Zoll E Series	ZOLL Medical Corporation	MKJ	Class III	2011-08-17
K111479	Revere Crosstop	Globus Medical, Inc.	NKB	Class II	2011-08-17
K111449	Revolve Additional Implants	Globus Medical, Inc.	NKB	Class II	2011-08-17
K111284	Flash-C Ptca Balloon Dilation Catheter - 5Mm X 19Mm X 135Cm / 6Mm X 19Mm X 135Cm	Verge Medical Inc.	LOX	Class II	2011-08-17
K111135	Pyrenees Cervical Plate System (Translational Plates)	K2M, Inc	KWQ	Class II	2011-08-17
K111083	Philips Avalon Fetal/maternal Monitors Fm20, Fm30, Fm40 and Fm50	Philips Medizinsysteme Boeblingen GmbH, Cardiac an	HGM	Class II	2011-08-17
K110736	Advia Chemistry Ferritin (Frt) Method	Siemens Healthcare Diagnostics Inc.	DBF	Class II	2011-08-17
K100602	Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test Strips	Nova Biomedical Corporation	KHP	Class I	2011-08-17
K111714	Hairmax Dual 12	Lexington International, LLC	OAP	Class II	2011-08-16
K111145	Endo Head	Medacta International SA	LZY	Class II	2011-08-16
K110397	Trumatch Personalized Solutions	Depuy Orthopaedics Inc.	JWH	Class II	2011-08-16
K101973	Omega Laboratories Hair Drug Screening Assay for Methamphetamine and 4-Methylenedioxymethamphetamine (Mdma)	Omega Laboratories, Inc.	LAF	Class II	2011-08-16
K111974	Ion Health Usb Insta-Scan Thermometer	Taidoc Technology Corporation	FLL	Class II	2011-08-15
K111247	Cranial Remolding Orthosis	Orthotic Care Services, LLP	MVA	Class II	2011-08-15
K111176	Osteomed Low Profile Neuro Fixation System	Osteomed	GWO	Class II	2011-08-15
K110277	Rapidpoint 405 Neonatal Bilirubin	Siemens Healthcare Diagnostics Inc.	MQM	Class I	2011-08-15
K103735	Mediled Mini	Medix I.C.S.A.	LBI	Class II	2011-08-15
K112103	Interlock-35 Fibered Idc Occlusion System	Boston Scientific Corporation	KRD	Class II	2011-08-12
K112034	Teca Elite Disposable Concentric Needles	Medtronic, Inc.	IKT	Class II	2011-08-12
K111739	Kids Rock 3 Chair	Pride Mobility Products Corp	IOR	Class I	2011-08-12
K111599	Vitek 2 Ast-St Linezolid	bioMerieux, Inc.	LON	Class II	2011-08-12
K111383	Zirprime	Noritake Co., Inc.	EIH	Class II	2011-08-12
K111347	Isrobot Mona Lisa	Biobot Surgical Pte. Ltd.	IYO	Class II	2011-08-12
K111300	Senstouch Nitrile Examination Gloves, Powder Free, Non Sterile (Green, Orange, Violet and White)	Pt Mahakarya Inti Buana	LZA	Class I	2011-08-12
K111053	Sentrysuite Product Line	Carefusion Germany 234 GmbH	BTY	Class II	2011-08-12
K110758	Nitrile Powder Free Examination Gloves	Hartalega Sdn Bhd	LZA	Class I	2011-08-12
K110627	Nexsite 9Fr Dual Lumen Critical Care Central Venous Catheter	Marvao Medical Devices Ltd.	LJS	Class II	2011-08-12
K110580	Narrow Connection Straumann Anatomic Ips E.max Abutments	Straumann USA, LLC	NHA	Class II	2011-08-12
K110486	Accusom	Novasom, Inc.	MNR	Class II	2011-08-12
K103699	Eactech Optecure Dental and Optecure Dental + Ccc	Exactech, Inc.	NUN	Class II	2011-08-12
K103448	Brivo Xr385	GE Healthcare	KPR	Class II	2011-08-12