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 569 of 3529

510(k) clearances, page 569 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K170292	Tri-Ex Extraction Balloon With Multiple Sizing	Wilson-Cook Medical Inc.	GCA	Class II	2017-09-20
K163614	PENTAX Medical ED34-i10T, Video Duodenoscope	PENTAX of America, Inc.	FDT	Class II	2017-09-20
K163283	Hamilton-H900, Hamilton-Bc8010, Hamilton-Bc4010	Hamilton Medical AG	BTT	Class II	2017-09-20
K172299	Accordion Piccolo Stone Management Device	Ths International, Inc. D/B/A Accordion Medical	FFL	Class II	2017-09-19
K172199	ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium	Medtronic Sofamor Danek	MAX	Class II	2017-09-19
K172196	ECOM™ Cardiac Output Monitoring System	Ecom Medical, Inc.	DSB	Class II	2017-09-19
K171964	LigaMetrics Suture Anchors	Mortise Medical, LLC	MBI	Class II	2017-09-19
K171632	da Vinci Xi Surgical System	Intuitive Surgical, Inc.	NAY	Class II	2017-09-19
K170002	Medline Blood Collection Set	MEDLINE INDUSTRIES, LP - Northfield	FPA	Class II	2017-09-19
K163611	Pain Therapy Device	Guangzhou Xinbo Electronic Co., Ltd	NUH	Class II	2017-09-19
K163518	Digital Thermometer	Joytech Healthcare Co., Ltd.	FLL	Class II	2017-09-19
K163135	Finger Pulse Oximeter	Shenzhen Fitfaith Technology Co.,Ltd	DQA	Class II	2017-09-19
K172587	Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers	Medacta International SA	ODP	Class II	2017-09-18
K170286	Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan (hioxifilcon A) Daily Wear Soft (Hydrophilic) Contact Lens for PRESBYOPIA	Largan Medical Co., Ltd.	LPL	Class II	2017-09-18
K170179	LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity	Lumenis Ltd	GEX	Class II	2017-09-18
K163664	Health-e-Connect System with IDA	Alr Technologies	NDC	Class II	2017-09-18
K163433	VITROS Chemistry Products GLU Slides	Ortho-Clinical Diagnostics, Inc.	CGA	Class II	2017-09-18
K163422	Shanghai Sanyou PEEK Cage System	Shanghai Sanyou Medical Co. Ltd	ODP	Class II	2017-09-18
K162828	Winback Back 3SE	Winback USA Corp	PBX	Class II	2017-09-18
K172506	BD Cathena Safety IV Catheter	Becton Dickinson & Co	FOZ	Class II	2017-09-17
K170640	Endoscope Sterilization Tray	Intuitive Surgical, Inc.	KCT	Class II	2017-09-17
K172522	Mazor X	Mazor Robotics Ltd	OLO	Class II	2017-09-15
K172519	PICO Single Use Negative Pressure Wound Therapy System	Smith & Nephew Medical Ltd	OMP	Class II	2017-09-15
K172356	BladderScan Prime PLUS System	Verathon Incorporated	IYO	Class II	2017-09-15
K172150	Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)	bioMerieux, Inc.	JWY	Class II	2017-09-15
K172064	Ti-Diagon Oblique TLIF	Camber Spine Technologies	MAX	Class II	2017-09-15
K171840	Stryker Consolidated Operating Room Equipment (CORE) 2 Console	Stryker Corp.	ERL	Class II	2017-09-15
K171785	WowGoHealth Blood Glucose Monitoring System	Biotest Medical Corp.	NBW	Class II	2017-09-15
K171686	Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System	Choicespine, LP	MQP	Class II	2017-09-15
K171652	Fresenius Liberty Select Cycler	Fresenius Medical Care Renal Therapies Group, LLC	FKX	Class II	2017-09-15
K171519	FLXfit™	Expanding Orthopedics, Inc.	MAX	Class II	2017-09-15
K171446	Cefaly Acute	Cefaly Technology	PCC	Class II	2017-09-15
K171176	M-CATH Microcatheter	Acrostak (Schweiz) AG	DQY	Class II	2017-09-15
K171123	Leksell Vantage Stereotactic System	Elekta Instrument AB	HAW	Class II	2017-09-15
K170838	Medentika CAD/CAM TiBases	Medentika GmbH	NHA	Class II	2017-09-15
K170527	Phoenix Clinical ICON	Phoenix Technology Group, Inc. dba Phoenix Clinical	HKI	Class II	2017-09-15
K170417	Glidewire GT	Terumo Corp.	DQX	Class II	2017-09-15
K170231	iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)	Andon Health Co., Ltd	NBW	Class II	2017-09-15
K163666	neuro inspire	Rensihaw PLC	HAW	Class II	2017-09-15
K163590	Psychemedics Microplate EIA for Benzodiazepines in Hair	Psychemedics Corp.	JXM	Class II	2017-09-15
K162482	A.B. DENTAL DEVICES Dental Implants System	A.B. Dental Device, Ltd.	DZE	Class II	2017-09-15
K172513	3D Echo	Jointvue, LLC	LLZ	Class II	2017-09-14
K172481	IntelliCart System	Dornoch Medical Systems	JCX	Class II	2017-09-14
K172479	Amsel Occluder Device	Amsel Medical Corporation	FZP	Class II	2017-09-14
K172385	Clarius Ultrasound System	Clarius Mobile Health Corp	IYN	Class II	2017-09-14
K172120	Veress Needle	WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd.	FHO	Class II	2017-09-14
K171953	Bard Mission Disposable Core Biopsy Instrument	Bard Peripheral Vascular Inc	KNW	Class II	2017-09-14
K171832	Range/Denali/Mesa Spinal System	K2M, Inc	NKB	Class II	2017-09-14
K171378	Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs	Semperit Investments Asia Pte, Ltd.	LZA	Class I	2017-09-14
K170937	VIPER PRIME navigated inserter	Medos International SARL	OLO	Class II	2017-09-14