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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 444 of 3528

510(k) clearances, page 444 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K191596	Arcadia Balloon Catheter	Merit Medical Systems, Inc.	HRX	Class II	2019-10-09
K191523	Visalys Restorative Primer	Kettenbach GmbH & Co KG	KLE	Class II	2019-10-09
K191359	Nipro Syringe	Nipro Medical Corporation	FMF	Class II	2019-10-09
K190630	SolidAIRity III Airway Stabilization System	Securisyn Medical, LLC	BTR	Class II	2019-10-09
K190321	Pediatric Nailing PlatformFemur	Orthopediatrics Corp	HSB	Class II	2019-10-09
K190314	Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000	Mednovel Technology, Ltd.	IYO	Class II	2019-10-09
K182448	AnyRidge Octa 1 Implant System	Megagen Implant Co., Ltd.	DZE	Class II	2019-10-09
K192206	32mm Glenosphere and Humeral Cup	Fx Shoulder USA, Inc.	PHX	Class II	2019-10-08
K191854	Premia Spine XL Instruments	Premia Spine Ltd.	OLO	Class II	2019-10-08
K191779	Attune Revision LPS Inserts	Depuy (Ireland)	KRO	Class II	2019-10-08
K191448	Barrier Sleeves	Ivoclar Vivadent, Inc.	PEM	Class II	2019-10-08
K191369	TSolution One Total Knee Application	Think Surgical Inc.	OLO	Class II	2019-10-08
K191150	Bodycad Unicompartmental Knee System	Bodycad Laboratories, Inc.	HSX	Class II	2019-10-08
K191133	KATANA Cleaner, KATANA Cleaner (Trial)	Kuraray Noritake Dental, Inc.	PME	Class II	2019-10-08
K191127	Advanced Intermezzo Implant System	Megagen Implant Co., Ltd.	DZE	Class II	2019-10-08
K183171	ScopeSeal Duodenoscope Protective Device	GI Scientific LLC	ODB	Class II	2019-10-08
K182773	Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps	Faulhaber Pinzetten OHG	GEI	Class II	2019-10-08
K191833	Dexcom G6 Pro Continuous Glucose Monitoring System	Dexcom, Inc.	QII	Class II	2019-10-07
K191632	PROFEMUR TL2 Stems	Microport Orthopedics Inc.	LZO	Class II	2019-10-07
K191431	Interlude Rolled Tampons in Plastic Applicator	Albaad Fem	HEB	Class II	2019-10-07
K190538	Nio-I	Waismed Ltd.	FMI	Class II	2019-10-07
K190086	Cepheid Xpert Respiratory Control Panel	Microbiologics, Inc.	PMN	Class II	2019-10-07
K192428	AFX Femoral Implant with Inserter	Cayenne Medical Inc.	MBI	Class II	2019-10-05
K192448	Delta Xtend Revers Shoulder System	Depuy (Ireland)	PHX	Class II	2019-10-04
K192433	LZI Methadone II Enzyme Immunoassay	Lin-Zhi International Inc	DJR	Class II	2019-10-04
K192422	Steerable Introducer 12F	Freudenberg Medical, LLC	DRA	Class II	2019-10-04
K192128	Sutter Arrowtip Monopolar Electrodes	Sutter Medizintechnik GmbH	GEI	Class II	2019-10-04
K192005	Bausch + Lomb PreVue Inserter for enVista Preloaded	Bausch & Lomb Incorporated	MSS	Class I	2019-10-04
K191994	ProFound AI Software V2.1	iCAD, Inc.	QDQ	Class II	2019-10-04
K191843	Ceramill A-Temp	Amann Girrbach AG	EBG	Class II	2019-10-04
K191713	CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)	Omega Medical Imaging, LLC	JAA	Class II	2019-10-04
K190940	Tokuyama Rebase III	Tokuyama Dental Corporation	EBI	Class II	2019-10-04
K190591	Safergel Sterile Ultrasound Gel	Safersonic US, Inc.	MUI	Class II	2019-10-04
K190298	DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12	Beckman Coulter Biomedical GmbH	CDD	Class II	2019-10-04
K190183	Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.	MEG	Class II	2019-10-04
K190060	Urethrotech UCD	Urethrotech	EZL	Class II	2019-10-04
K183710	Vivio System	Avicena, LLC	DQD	Class II	2019-10-04
K183441	Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs	Semperit Investments Asia Pte, Ltd.	LZA	Class I	2019-10-04
K192427	Ablation Confirmation	Neuwave Medical, Inc.	JAK	Class II	2019-10-03
K192424	Mobius3D	Varian Medical Systems, Inc.	IYE	Class II	2019-10-03
K192400	Evs 4343A, Evs 4343Ag, Evs 3643A, Evs 3643Ag	DRTECH Corporation	MQB	Class II	2019-10-03
K192398	Millenium HX	Evoqua Water Technologies LLC	FIP	Class II	2019-10-03
K192318	Ultraverse 014 and 018 PTA Balloon Dilatation Catheters	Bard Peripheral Vascular Inc	LIT	Class II	2019-10-03
K191993	Yumizen C1200 CRP	Horiba Abx SAS	DCK	Class II	2019-10-03
K191806	Propex IQ Apex Locator	Dentsply Sirona Inc	LQY	Unclassified	2019-10-03
K191794	Vintage Art Universal	Shofu Dental Corp.	EIH	Class II	2019-10-03
K191490	Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe	Jiangsu Caina Medical Co., Ltd	MEG	Class II	2019-10-03
K191344	Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module	Arthrex GmbH	HRS	Class II	2019-10-03
K191332	XACT Robotic System	Xact Robotics, Ltd.	JAK	Class II	2019-10-03
K191099	Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel	Atlas Medical	DKZ	Class II	2019-10-03