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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 634 of 3529

510(k) clearances, page 634 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K161565	Duo	Stetic Medical Aesthetics Development (Shenzhen) Co.,Ltd	ONF	Class II	2016-09-01
K161392	Elation Pulmonary Balloon Dilation	Merit Medical Systems, Inc.	KTI	Class II	2016-09-01
K161320	EMG Pink Nitrile Examination Glove Powder Free	Eco Medi Glove Sdn Bhd	LZA	Class I	2016-09-01
K161312	Sysmex Automated Blood Coagulation Analyzer CS-2100i	Siemens Healthcare Diagnostics Products Limited	JPA	Class II	2016-09-01
K161239	Mta2.2 Material	Avalon Biomed, Inc.	KIF	Class II	2016-09-01
K161063	EzRay Air (Model VEX-P300)	Vatech Co., Ltd.	EHD	Class II	2016-09-01
K160606	BC-5D Hematology Control	R & D Systems, Inc.	JPK	Class II	2016-09-01
K160531	Noiselezz	Firma Ingemarsson	LRK	Class II	2016-09-01
K160429	BC-5390 Auto Hematology Analyzer	Mindray Bio-Medical Electronics Co., Ltd.	GKZ	Class II	2016-09-01
K160274	Hi bebe plus	Bistos co., Ltd.	HGX	Class II	2016-09-01
K153599	Concert Medical Hands-Free Syringe (HFS)	Concert Medical, LLC	FRN	Class II	2016-09-01
K153469	Cathtong I PICC Catheter	L & z US, Inc.	LJS	Class II	2016-09-01
K152405	IBL 5000 Tanning Booth	Ibl Acquisitions LLC	LEJ	Class II	2016-09-01
K162152	Erbe’s CO2 Tubing/Cap Sets	Erbe USA Inc	FEQ	Class II	2016-08-31
K162129	RENASYS-G Gauze Dressing Kits with Soft Port	Smith & Nephew, Inc.	OMP	Class II	2016-08-31
K162001	1.5T and 3.0T 16 CH GE Shoulder Coils	Invivo Corporation	MOS	Class II	2016-08-31
K161588	Vscan Extend	GE Healthcare	IYN	Class II	2016-08-31
K161544	Trojan Chain Reaction Personal Lubricant	Church & Dwight Co., Inc.	NUC	Class II	2016-08-31
K161452	MicroPlex Coil System (MCS) - HyperSoft 3D	Terumo Cardiovascular Systems Corporation	HCG	Class II	2016-08-31
K161397	MAGiC	GE Healthcare	LNH	Class II	2016-08-31
K161367	HydroCoil Embolic System (HES)	Terumo Cardiovascular Systems Corporation	HCG	Class II	2016-08-31
K160944	ACCU-CHEK Guide Blood Glucose Monitoring System	Roche Diabetes Care, Inc.	NBW	Class II	2016-08-31
K153649	Exactech® Novation® Element Press-fit Femoral Stem	Exactech, Inc.	MEH	Class II	2016-08-31
K151047	MTA Repair HP	Angelus Industria de Productos Odontologicos	KIF	Class II	2016-08-31
K162189	ANAX™ 5.5 Spinal System	CG MedTech Co., Ltd.	MNH	Class II	2016-08-30
K161251	CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests	Hangzhou Clongene Biotech Co., Ltd.	DKZ	Class II	2016-08-30
K160723	OnSight 3D Extremity System	Eastman Kodak Company	JAK	Class II	2016-08-30
K160149	Miret Grasper, Alligator, Miret Grasper, Maryland	Miret Surgical, Inc.	OCW	Class II	2016-08-30
K153193	Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)	Zyno Medical LLC.	FRN	Class II	2016-08-30
K162119	UreTron PF Series Probe	Med-Sonics Corp.	FFK	Class II	2016-08-29
K161777	BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems	Becton Dickinson Infusion Therapy Systems Inc.	FOZ	Class II	2016-08-29
K161619	Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems	Cepheid	OUY	Class II	2016-08-29
K161570	Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large	Lc Medical Concepts, Inc.	OMP	Class II	2016-08-29
K161532	Philips Avent Comfort Single/Twin Electric Breast Pump	Philips Consumer Lifestyle - Innovation Site Eindhoven	HGX	Class II	2016-08-29
K161311	USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles	Strukmyer Medical	FRO	Unclassified	2016-08-29
K161211	Digital Thermometer	Biocare Asia Corporation, Ltd.	FLL	Class II	2016-08-29
K161108	Arthrex VaultLock Glenoid	Arthrex GmbH	KWS	Class II	2016-08-29
K160626	ATLANTIS Abutment for HIOSSEN ET implant	Dentsply Sirona Inc	NHA	Class II	2016-08-29
K160597	INDEPENDENCE MIS Spacers	Globus Medical, Inc.	OVD	Class II	2016-08-29
K153706	Insulin Pen Needle	Sterilance Medical (Suzhou) Inc.	FMI	Class II	2016-08-29
K152931	Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator	Ambu A/S	BTM	Class II	2016-08-29
K162094	RS80A Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	IYN	Class II	2016-08-26
K161545	Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant	Church & Dwight Co., Inc.	HIS	Class II	2016-08-26
K161503	Orion	Yerim Engineering Co., Ltd.	GEX	Class II	2016-08-26
K161124	EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear	Vision Science Co., Ltd.	LPL	Class II	2016-08-26
K161030	ATLANTIS Abutment for CONELOG implant	Dentsply Sirona Inc	NHA	Class II	2016-08-26
K160943	Bite Away	Riemser Pharma	IRT	Class II	2016-08-26
K160797	FMX314 Surgical Platform	Fortimedix Surgical B.V.	OTJ	Class II	2016-08-26
K160615	Orthodontic Ceramic Brackets 1.1	Tomy, Inc.	NJM	Class II	2016-08-26
K160600	Freedom Spinal Cord Stimulator System	Stimwave Technologies Incorporated	GZB	Class II	2016-08-26