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 979 of 3531

510(k) clearances, page 979 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K101270	Swabflsuh (3Ml, 5Ml, 10Ml) Model 10331, 10351, 10311	Excelsior Medical LLC	NGT	Class II	2011-02-10
K093661	Colonring	Niti Surgical Solutions, Ltd.	FZP	Class II	2011-02-10
K092202	Eswallow Dysphagia Therapy Kit, Pmi Dysphagia Therapy Kit	Eswallow USA	IPF	Class II	2011-02-10
K110205	Aaio-7, Aaio Wirless	Appasamy Associates	HLI	Class II	2011-02-09
K110010	Neuroport Cortical Microelectrode Array System	Blackrock Microsystems	GZL	Class II	2011-02-09
K103310	Cryonize Tm	3jt Enterprises, LLC	GEH	Class II	2011-02-09
K103145	Hammerloc Tm Tibial Fixation Device	Biomet Sports Medicine	MBI	Class II	2011-02-09
K103085	Venus Basic Spinal Fixation System	L&K Biomed Co.,Ltd.	MNH	Class II	2011-02-09
K102296	Verify Chemical Monitoring Strip for Resert Soultions (Resert Xl Test Strip Version 2)	STERIS Corporation	JOJ	Class II	2011-02-09
K101979	Explorer Liver (Passive Tracking)	Pathfinder Therapeutics, Inc.	OEW	Class II	2011-02-09
K100945	Fuse Plif Cafe	Advanced Medical Technologies AG	MAX	Class II	2011-02-09
K100225	Pulse Oximeter Model P10	Mediana Co., Ltd.	DQA	Class II	2011-02-09
K110202	Fujifilm Diagnostic Ultrasound System Fazone Cb	FUJIFILM Healthcare Americas Corporation	ITX	Class II	2011-02-08
K110199	Dc-T6 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2011-02-08
K110192	Defibrillator Analyzer - Da-2006P	BC Group International Inc	DRL	Class II	2011-02-08
K110069	Smith & Nephew, Inc Spatialframe V4.1 Web-Based Software	Smith & Nephew, Inc.	KTT	Class II	2011-02-08
K103781	Med-Lok Safety Needle	Sta-Med, LLC	MEG	Class II	2011-02-08
K103507	Medical Visors Mv100	Medical Visors, Inc.	LNH	Class II	2011-02-08
K103316	Flowrest	Vapotherm Inc.	BTT	Class II	2011-02-08
K103276	Intel Health Guide	Intel Corporation Digital Health Group	DRG	Class II	2011-02-08
K103195	I-Stat 1 Wireless Analyzer	Abbott Medical	CGA	Class II	2011-02-08
K103186	Skintact Radiotransparent Multifunction Electrodes	Leonhard Lang GmbH	MKJ	Class III	2011-02-08
K103183	Trilliant Surgical Subtalar Implant	Trilliant Surgical LLC	HWC	Class II	2011-02-08
K103102	Leucadia Pedicle Screw System	Phygen, LLC	MNI	Class II	2011-02-08
K103040	Lanx Posterior Cervicothoracic Spinal Fixation System (Pcfs)	Lanx, Inc.	NKB	Class II	2011-02-08
K101988	Heal Force CO2 Incubator	Shanghai Lishen Scientific Equipment Co., Ltd.	MQG	Class II	2011-02-08
K101902	J Tac Model Jt-Md-035, Jt-Md-040, Jt-Md-045, Jt-Cl-030	Jeil Medical Corporation	DZL	Class II	2011-02-08
K101236	Voluson E6/e8/e8 Expert Diagnostic Ultrasound System Model: H48681bd/ H48681bx/ H48681bm	GE Healthcare	IYN	Class II	2011-02-08
K100533	Vista Endoscope,89 Cm, 56Cm , Scout Blunt-Tipped Guide- 106 Cm, 86 Cm, 53 Cm, Models Fg0027, Fg0031, Fg0029, Fg 0028,	Vibrynt, Inc.	GCJ	Class II	2011-02-08
K110164	5.5Mm Spartan Peek Suture Implant W/ #2 Magnum Wire, Punch Tap, Extraction Tool	ArthroCare Corporation	MBI	Class II	2011-02-07
K103787	Medeor Matrix	DSM Biomedical, Inc.	FTM	Class II	2011-02-07
K103474	Ena Temp and Enamel Plus Temp (Two Different Proprietary Names for the Same Product)	Micerium S.p.A.	EBG	Class II	2011-02-07
K103373	Synchron Systems Cholinesterase (Chex) Model A53722	Siemens Healthcare Diagnostics Inc.	DIH	Class I	2011-02-07
K103192	Navigation Marker, Reflective Marker Spheres	Ilumark GmbH	HAW	Class II	2011-02-07
K103173	Vitoss Ba Bimodal Bioactive Bone Graft Substitute	DSM Biomedical, Inc.	MQV	Class II	2011-02-07
K103158	Straight Handpiece Adapter; Contra Handpiece Adapter; Twist Handpiece Adapter; Flex Handpiece Adapter	Angstrom Mfg., Inc.	EGS	Class I	2011-02-07
K103054	Periopatch	Izun Pharmaceuticals	OLR	Unclassified	2011-02-07
K102547	Coroent Interlock System	NuVasive Inc	OVE	Class II	2011-02-07
K102470	Lugasure Curved, Small Jaw, Open Sealer/divider	Covidien, Formerly Valleylab	GEI	Class II	2011-02-07
K101900	Hakki Urinary Catheter; Size 14, 16, 18, 20, 22, 24, 26 French	Hakki Medical Technologies, Inc.	GBM	Class II	2011-02-07
K101439	Codonics Safe Labeling System (Sls), Model 500I/500p	Codonics, Inc.	BSZ	Class II	2011-02-07
K082255	Quadscan 4000 Body Body Composition, Fluid & Illness/segmental Monitoring Unit	Bodystat Ltd	MNW	Class II	2011-02-07
K082254	Modification to Bodystat 1500Mdd Body Composition Monitoring Unit	Bodystat Ltd	MNW	Class II	2011-02-07
K110124	Fetal Doppler Jpd-100S	Shenzhen Jumper Medical Equipment Co.,Ltd.	KNG	Class II	2011-02-04
K110104	Blanketrol II Hyper-Hypothermia Temperature Managment System	Gentherm Medical, LLC	DWJ	Class II	2011-02-04
K103816	Cohesion Bone Cement	Teknimed SAS	NDN	Class II	2011-02-04
K103785	Mobile Mim	MIM Software Inc	LLZ	Class II	2011-02-04
K103732	Spacelabs Model 90217A Ambulatory Blood Pressure (Abp) Monitor	GE Healthcare	DXN	Class II	2011-02-04
K103707	Vectec Disposable Monopolar Connector Cable	Vectec	GEI	Class II	2011-02-04
K103516	Audicor Sensor-Adapter Model Audicor Sensor-Adapter 4.0	Inovise Medical, Inc.	DQD	Class II	2011-02-04