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 581 of 3529

510(k) clearances, page 581 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K163571	Great Basin Stool Bacterial Pathogens Panel	Great Basin Scientific, Inc.	PCI	Class II	2017-07-12
K163560	Reprocessed AcuNav Diagnostic Ultrasound Catheter	Innovative Health, LLC.	OWQ	Class II	2017-07-12
K163504	Borrelia B31 ViraChip IgG Test Kit	Viramed Biotech AG	LSR	Class II	2017-07-12
K163137	NIRA Beauty Skin Laser	Dermal Photonics Corp	OHS	Class II	2017-07-12
K163057	Relizorb	Alcresta Therapeutics, Inc.	PLQ	Class II	2017-07-12
K171908	3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing	3M Company	SEL	Unclassified	2017-07-11
K171780	OrthAlign Plus System	OrthAlign, Inc.	OLO	Class II	2017-07-11
K171401	ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1	ELITechGroup Inc	CIG	Class II	2017-07-11
K171316	O2Vent W	Oventus Manufacturing Pty, Ltd.	LRK	Class II	2017-07-11
K171133	Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories	Qfix	IYE	Class II	2017-07-11
K171105	AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems	Supersonic Imagine	IYN	Class II	2017-07-11
K171000	P60 Series Digital Color Doppler Ultrasound System	Sonoscape Medical Corp.	IYN	Class II	2017-07-11
K170814	Devon 24	Devon Medical Products (Jiangsu) Ltd	JOW	Class II	2017-07-11
K170503	EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages	Eit Emerging Implant Technologies GmbH	MAX	Class II	2017-07-11
K163406	Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System	Acon Laboratories, Inc.	CHH	Class I	2017-07-11
K163353	Needle's Eye Snare Retrieval Set - 54cm	Cook Incorporated	DXE	Class II	2017-07-11
K162881	Kitazato OPU Needles	Kitazato Corporation	MQE	Class II	2017-07-11
K162470	RT300 FES cycle ergometer	Restorative Therapies Inc.	GZI	Class II	2017-07-11
K171092	XiniWave II Model ECS322P	International Trade Group, Inc.	NGX	Class II	2017-07-10
K171078	Tri-Combo Parasite Screen	Techlab, Inc.	MHJ	Class II	2017-07-10
K171034	M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2017-07-10
K170768	Mini Needle	Ocuject, LLC	FMI	Class II	2017-07-10
K170397	Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs	Kossan International Sdn Bhd	LZA	Class I	2017-07-10
K162934	Biodesign Parastomal Hernia Repair Graft	Cook Biotech Incorporated	FTM	Class II	2017-07-10
K171711	Thunder, Thunder VT, Thunder HR	Quanta System Inc.	GEX	Class II	2017-07-07
K171698	Smart Syringe	Osprey Medical, Inc.	DXT	Class II	2017-07-07
K171461	SkyPlate Detector for Philips Radiography/Fluoroscopy Systems	Philips Medical Systems DMC GmbH	MQB	Class II	2017-07-07
K171454	Interject Injection Therapy Needle Catheter	Boston Scientific Corporation	FBK	Class II	2017-07-07
K171448	Hammertoe Correction System	Life Spine	HWC	Class II	2017-07-07
K171339	EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs	Eco Medi Glove Sdn Bhd	LZA	Class I	2017-07-07
K171087	AXON IR Heat Lamp	Crystal MedTech, LLC	ILY	Class II	2017-07-07
K171069	ZELTIQ CoolSculpting System	Zeltiq Aesthetics Inc	OOK	Class II	2017-07-07
K171046	SeaSpine Cambria System	SeaSpine Orthopedics Corporation	ODP	Class II	2017-07-07
K170941	RX NC Takeru PTCA Balloon Dilatation Catheter	KANEKA Corporation	LOX	Class II	2017-07-07
K170541	Anorganic Bone Mineral in Delivery Applicator	Collagen Matrix, Inc	NPM	Class II	2017-07-07
K170480	Models 3543A, 4343A, 2929A and A843B	Shanghai PZ Medical Technolgoy Co., Ltd.	MQB	Class II	2017-07-07
K163648	Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series	Grandway Technology (Shenzhen) Limited	DXN	Class II	2017-07-07
K163584	M3290B Philips IntelliVue Information Center iX	Philips North America LLC	MHX	Class II	2017-07-07
K163035	DilaCheck Nitrile Powder Free Examination Glove, (Sterile)	Elm Tree Medical, Inc.	LZA	Class I	2017-07-07
K162992	Karl Storz UROMAT E.A.S.I.	Karl Storz Endoscopy-America, Inc.	LJH	Class II	2017-07-07
K161349	Everyway Incontinence Stimulation System	Everyway Medical Instrument Co., Ltd.	KPI	Class II	2017-07-07
K160337	Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns	Bam Corporation Limited	QPC	Class II	2017-07-07
K171666	MPR2 logO DATALOGGER	Raumedic AG	GWM	Class II	2017-07-06
K171398	Dermal Cooling System	R2 Dermatology	GEH	Class II	2017-07-06
K171055	Philips BlueControl	Philips Electronics Nederland B.V.	ONE	Class II	2017-07-06
K171031	CRESCENT™ Spinal System	Medtronic Sofamor Danek	MAX	Class II	2017-07-06
K170870	Site~Rite Halcyon Diagnostic Ultrasound System	Chison Medical Imaging Co., Ltd.	IYN	Class II	2017-07-06
K170815	PSA Cable	Boston Scientific Corporation	DTC	Class II	2017-07-06
K170587	On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis	Acon Laboratories, Inc.	JIN	Class I	2017-07-06
K170567	Tempus Pro Patient Monitor	Remote Diagnostic Technologies Ltd.	MHX	Class II	2017-07-06