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 568 of 3529

510(k) clearances, page 568 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K172126	Xpert Xpress Strep A	Cepheid	PGX	Class II	2017-09-25
K171943	Electrocardiograph	Edan Instruments, Inc.	DPS	Class II	2017-09-25
K171862	GALAXY G3 Mini Microcoil Delivery System	Cerenovus, Inc.	HCG	Class II	2017-09-25
K171726	LapBag	Sejong Medical Co., Ltd.	GCJ	Class II	2017-09-25
K171442	Exofin Fusion Skin Closure System	Chemence Medical Inc.	OMD	Class II	2017-09-25
K171161	Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)	Dimensional Bioceramics, LLC	MQV	Class II	2017-09-25
K170985	Urbanek Device	TMJ Services LLC	MQC	Unclassified	2017-09-25
K170157	INDEPENDENCE® Spacers	Globus Medical, Inc.	OVD	Class II	2017-09-25
K163577	Ecofit® Hip System	implantcast GmbH	LZO	Class II	2017-09-25
K163270	ISEN-Goggles with Data Viewer	Isent Tech & Trading Company, Ltd.	GWN	Class II	2017-09-25
K171460	Powder-free Clear Vinyl Patient Examination Gloves	Shandong Zhiwei Medical Products, Co., Ltd.	LYZ	Class I	2017-09-24
K172571	ULTRASCORE Focused Force PTA Balloon	Bard Access Systems, Inc.	PNO	Class II	2017-09-22
K172545	SERI Contour	Sofregen Medical, Inc.	OXF	Class II	2017-09-22
K172544	IV Fat Emulsion Administration Sets	Baxter Healthcare Corporation	FPA	Class II	2017-09-22
K172086	Matira™ Anterior Cervical System	Kalitec Direct, LLC	KWQ	Class II	2017-09-22
K171986	Sterling Supreme Diode Laser	Cao Group, Inc.	GEX	Class II	2017-09-22
K171599	WiTouch Pro, WiTouch, Neubac	Hollywog, LLC	NUH	Class II	2017-09-22
K171499	Occlusion Detection Dressing Kit	Cardinalhealth	OMP	Class II	2017-09-22
K171303	Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664	University of Texas Medical School at Houston, Texas	KPS	Class II	2017-09-22
K171262	TempSure	Cynosure, LLC	GEI	Class II	2017-09-22
K170956	SYSTEM 1E Liquid Chemical Sterilant Processing System	STERIS Corporation	MED	Class II	2017-09-22
K170758	Thermage FLX System and Accessories	Solta Medical, Inc.	GEI	Class II	2017-09-22
K163674	Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry	Neo Cosmetique	NUC	Class II	2017-09-22
K162956	Nowcardio System	Contex International Technologies (Canada), Inc.	QYX	Class II	2017-09-22
K162848	Straumann CARES Golden Ti/TiN Abutments	Straumann USA, LLC	NHA	Class II	2017-09-22
K172501	iNSitu Total Hip System	Theken Companies LLC	LPH	Class II	2017-09-21
K172486	Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 250mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 500mL bottle	Anexa Biomedical, Inc.	FRO	Unclassified	2017-09-21
K172219	Mako Total Knee Application	Mako Surgical Corp.	OLO	Class II	2017-09-21
K172082	S60 Series Digital Color Doppler Ultrasound System	Sonoscape Medical Corp.	IYN	Class II	2017-09-21
K171891	ZS3 Ultrasound System, z.one pro Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2017-09-21
K171852	DARCO Locking Bone Plate System	Wrightmedicaltechnologyinc	HRS	Class II	2017-09-21
K171829	EndoNaut	Therenva SAS	OWB	Class II	2017-09-21
K171804	Zap-X Radiosurgery System	Zap Surgical Systems Inc.	IYE	Class II	2017-09-21
K171232	PeriView FLEX	Olympus Surgical Technologies America	KTI	Class II	2017-09-21
K171184	Persyst Mobile App	Persyst Development LLC	OMB	Class II	2017-09-21
K170879	IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories	Intuitive Surgical, Inc.	NAY	Class II	2017-09-21
K170705	ARIX Wrist System	Jeil Medical Corporation	HRS	Class II	2017-09-21
K170641	da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes	Intuitive Surgical, Inc.	NAY	Class II	2017-09-21
K170118	Scanostics UTI Check Application Test System	Teco Diagnostics	JMT	Class I	2017-09-21
K170013	Eztetic BellaTek Encode Healing Abutments	ZimVie US Corp LLC	NHA	Class II	2017-09-21
K163462	AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX	Radiometer Medical ApS	JHX	Class II	2017-09-21
K161719	Salter Labs Bubble Humidifier	Salter Labs	BTT	Class II	2017-09-21
K172566	Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices	Hologic, Inc.	HIH	Class II	2017-09-20
K172521	PICO Single Use Negative Pressure Wound Therapy System	Smith & Nephew Medical Ltd	OMP	Class II	2017-09-20
K172314	Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)	Art Optical Contact Lens, Inc.	HQD	Class II	2017-09-20
K172279	PMT Posterior Fixation System	Providence Medical Technology, Inc.	NKG	Class II	2017-09-20
K172247	Magic3 Go Intermittent Urinary Catheter	C.R. Bard Inc	EZD	Class II	2017-09-20
K171876	Ceramill Zolid HT+ white	Amann Girrbach AG	EIH	Class II	2017-09-20
K171822	NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)	Biotest Medical Corp.	NBW	Class II	2017-09-20
K171541	Powder Free Nitrile Examination Gloves (Orange)	Comfort Rubber Gloves Industries Sdn Bhd	LZA	Class I	2017-09-20