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 811 of 3530

510(k) clearances, page 811 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K130897	Medcomp Vascu-Picc with Valve	Medcomp ( Medical Components)	LJS	Class II	2013-10-22
K132181	Gyrus Acmi Uro-Ezdilate Ureteral Balloon Dilation Catheter	Olympus Surgical Technologies America	EZN	Class II	2013-10-21
K132013	Swift Air	ResMed Corp	BZD	Class II	2013-10-21
K131630	Puritan Amies Medium Collection and Transport System	Puritan Medical Products Company, LLC	LIO	Class I	2013-10-21
K130528	Bioplex 2200 Apls Igm	Bio-Rad Laboratories Inc.	MID	Class II	2013-10-21
K130198	Neo Denta Zirconia	Neo Group Limited	EIH	Class II	2013-10-21
K132947	Direxion and Direxion Hi-Flo Torqueable Microcatheters	Boston Scientific Corporation	KRA	Class II	2013-10-18
K132571	Elecsys Ck-Mb Stat Immunoassay, Elecsys Ck-Mb Immunoassay	Roche Diagnostics GmbH	JHY	Class II	2013-10-18
K132096	Rapidfret Oral Fluid Assay for Thc, Thc Calibrator Set, Thc Control Set, Collector	Biophor Diagnostics, Inc.	LDJ	Class II	2013-10-18
K131982	Remstar Auto a-Flex Ht	Respironics, Inc.	BZD	Class II	2013-10-18
K131947	Provox Vega Puncture Set	Atos Medical AB	EWL	Class II	2013-10-18
K131859	Multifunctional Series	Beijing Honkon Technologies Co., Ltd.	ONF	Class II	2013-10-18
K131663	Echelon Endoscopic Linear Cutter Reload, Black	Ethicon Endo-Surgery Inc	GDW	Class II	2013-10-18
K131214	Cranial Map Neuro	Stryker Corporate	HAW	Class II	2013-10-18
K130684	Philips Heartstart Fr3 Automated External Defibrillator	Philips North America LLC	MKJ	Class III	2013-10-18
K130504	Asa Oral Appliances	American Sleep Association	LRK	Class II	2013-10-18
K130213	Quickprofile Single Drug of Abuse Device and Quick Profile Multi-Drugs of Abuse Screen Device	LumiQuick Diagnostics Inc.	LDJ	Class II	2013-10-18
K122848	Lenstec Lc Injection System	Lenstec, Inc.	MSS	Class I	2013-10-18
K122437	No-Profile Screws No-Profile Washer No-Profile Screws Washerloc Washers	Biomet Sports Medicine	MBI	Class II	2013-10-18
K132942	Site-Rite Vision II Ultrasound System	C.R. Bard Inc	IYN	Class II	2013-10-17
K132636	Dyonics Plan Hip Impingement Planning System	Smith & Nephew, Inc.	LLZ	Class II	2013-10-17
K132612	Harmonic Ace+ Shears 23 Cm Length with Advanced Hemostasis, Harmonic Ace + Laparoscopic Shears 36 Cm Length with Advance	Ethicon Endo-Surgery Inc	LFL	Unclassified	2013-10-17
K132468	Mrsa/sa Elite Mgb, Elite Mgb Software	Elitechgroup Epoch Biosciences	NQX	Class II	2013-10-17
K132438	Imagenet 5 Pc Software System	Topcon Healthcare, Inc.	NFJ	Class II	2013-10-17
K132430	Sterling Over-the-Wire (Otw) Pta Balloon Dilatation Catheter	Boston Scientific Corporation	LIT	Class II	2013-10-17
K132272	Glooko Device System for Glooko Application	Glooko Inc	NBW	Class II	2013-10-17
K132251	Aptima Combo 2 Assay (Panther System)	Hologic / Gen-Probe Incorporated	LSL	Class II	2013-10-17
K132127	Transcend Auto	Somnetics International, Inc	BZD	Class II	2013-10-17
K131994	Somnolyzer 24X7	Respironics, Inc.	MNR	Class II	2013-10-17
K131872	Intellivue Patient Monitor Mx500, Intellivue Patient Monitor Mx550	Philips Medizinsysteme Boeblingen GmbH, Cardiac an	MHX	Class II	2013-10-17
K131775	Universal Neuro 3 System	Stryker Corp.	GWO	Class II	2013-10-17
K131459	Aap K-Wire, Steinmann Pin, Cerclage Wire	AAP Implantate AG	JDW	Class II	2013-10-17
K131167	Univation	Aesculap Inc	HRY	Class II	2013-10-17
K131013	Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring System	Nova Biomedical Corporation	NBW	Class II	2013-10-17
K130958	True Spinal Fixation System	Innovative Surgical Designs, Inc.	MNI	Class II	2013-10-17
K130942	Legacy Medical Eco-Choice Disposable Blood Pressure Cuff	Legacy Medical, Inc.	DXQ	Class II	2013-10-17
K130719	Tvc Imaging System, Tvc Insight Catheter	Nipro Vascular Innovations Americas, Inc.	OGZ	Class II	2013-10-17
K130601	Bioroot Rcs	Novocol, Inc.	KIF	Class II	2013-10-17
K130378	Respiguide Delivery System	Respicardia, Inc.	DQY	Class II	2013-10-17
K124041	Nbm-200Mp	Orsense Ltd	DQA	Class II	2013-10-17
K123049	Sapphire Infusion Pump	Q Core Medical, Ltd.	FRN	Class II	2013-10-17
K132664	Advia Chemistry Albumin Bcp Reagent (Albp), Advia Chemistry Albumin Bcp Calibrator	Siemens Healthcare Diagnostics Inc.	CJW	Class II	2013-10-16
K132461	A.i.m. Suture Anchor	Anchor Innovation Medical, Inc.	MBI	Class II	2013-10-16
K132236	.Decimal Proton Aperture	.Decimal, Inc.	IXI	Class II	2013-10-16
K132160	Vantage Titan 3T	Toshibamedical Systems Corporation	LNH	Class II	2013-10-16
K131640	Smooth or Threaded Metallic Bone Fastener	Biomedical Ent., Inc.	HTY	Class II	2013-10-16
K131405	Ifuse Implant System	SI-Bone, Inc.	OUR	Class II	2013-10-16
K131231	Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture Shoulder Prothesis	Tornier S.A.S.	PHX	Class II	2013-10-16
K131047	Fingertip Pulse Oximeter	Beijing Choice Electronic Technololgy Co., Ltd.	DQA	Class II	2013-10-16
K131022	Ovation 10/12 Hip Stem	Ortho Development Corp.	LPH	Class II	2013-10-16