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 334 of 3528

510(k) clearances, page 334 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K211699	Nitrile Exam Gloves, Powder Free, Blue	Hengchang (Dongying) Medical Technology Co., Ltd.	LZA	Class I	2021-08-20
K211551	Wishbone HA	Wishbone	NPM	Class II	2021-08-20
K211527	Exo Iris	Exo Imaging, Inc.	IYN	Class II	2021-08-20
K211194	Molekule Air Pro	Molekule, Inc.	FRA	Class II	2021-08-20
K210887	Altus Spine Sochi OCT Spinal System	Altus Partners	NKG	Class II	2021-08-20
K210800	IO Expandable Lumbar Interbody Fusion System	Mirus, LLC	MAX	Class II	2021-08-20
K210533	Inset Reverse Total Shoulder System	SHOULDER INNOVATIONS, Inc	PHX	Class II	2021-08-20
K203790	GEM Premier 5000	Instrumentation Laboratory Co.	CHL	Class II	2021-08-20
K203705	Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)	Careplus (M) Sdn Bhd	LYY	Class I	2021-08-20
K203622	Medical Gloves	Beijing Biosis Healing Biolog Ical Technology Co., Ltd.	LZA	Class I	2021-08-20
K203607	MOSS VRS Spinal System	BIEDERMANN MOTECH GmbH & Co. KG	NKB	Class II	2021-08-20
K203486	Otoplan	Cascination	QQE	Class II	2021-08-20
K203029	Auxilock Titanium Interference Screw	Auxein medical Private Limited	HWC	Class II	2021-08-20
K202705	Prime and DYNASTY® Additive Manufacturing Shells	Microport Orthopedics Inc.	OQG	Class II	2021-08-20
K202670	Nam illumination probe with chopper	Oculight Co.,Ltd.	MPA	Class II	2021-08-20
K201857	Powder Free Nitrile Examination Glove Black and Dual Color White-Blue	Careplus (M) Sdn Bhd	LZA	Class I	2021-08-20
DEN190056	ADVIA Centaur Enhanced Liver Fibrosis (ELF)	Siemens Healthcare Diagnostics Inc.	QQB	Class II	2021-08-20
K212304	Callaly Tampliner (super plus absorbency)	Calla Lily Personal Care, Ltd.	HEB	Class II	2021-08-19
K212296	Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2	FUJIFILM Corporation	FDS	Class II	2021-08-19
K212185	Golden Isles Pedicle Screw System	Intelivation, LLC	NKB	Class II	2021-08-19
K211620	Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)	Shen Wei (USA), Inc.	LYY	Class I	2021-08-19
K211584	Oral Surgery Contra	Nakanishi Inc.	KMW	Class II	2021-08-19
K211576	WYZ Surgical Mask	Wyz Medical Supplies, LLC	FXX	Class II	2021-08-19
K211462	Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask	Xiantao S&J Protective Products Co., Ltd	FXX	Class II	2021-08-19
K211328	Eidon Fa, Eidon, Eidon Af, Eidon Uwfl	Centervue	MYC	Class II	2021-08-19
K211319	Purism Non-Sterile Powder Free Nitrile Examination Gloves	Dezhou Purism Medical Technology Co., Ltd.	LZA	Class I	2021-08-19
K211104	AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set	ConMed Corporation	HIF	Class II	2021-08-19
K211066	Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3	Homtex, Inc.	FXX	Class II	2021-08-19
K210749	Empty EVA Bag	Haemotronic, Inc.	KPE	Class II	2021-08-19
K210698	ECOMA Level 2 Disposable Surgical Mask with Ear Loops	Xianning Eco Medical Articles Co., Ltd.	FXX	Class II	2021-08-19
K210362	s-Clean Pre-Milled Abutment	Dentis Co.,Ltd	NHA	Class II	2021-08-19
K210317	Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System	Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)	IYN	Class II	2021-08-19
K210256	CiRx (R) Surgical Mask	Ningbo Shun YE Medical Company, Ltd.	FXX	Class II	2021-08-19
K210203	mmRNA appliance	Vivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I)	LRK	Class II	2021-08-19
K203633	Enteral Extension Sets	Gbuk Group Limited	PIF	Class II	2021-08-19
K202836	GX Navigation Instrument System	Life Spine	OLO	Class II	2021-08-19
K202652	Servator P SALF Solution with THAM	S.A.L.F. SpA	KDN	Class II	2021-08-19
K202425	SurgiLattice scaffold	Tepha, Inc.	OOD	Class II	2021-08-19
DEN210013	OsteoProbe	Active Life Scientific, Inc.	QGQ	Class II	2021-08-19
K212322	Cellvizio I.V.E. system with Confocal Miniprobes	Mauna Kea Technologies	OWN	Class II	2021-08-18
K212097	Disposable medical surgical mask	Hebei Titans Hongsen Medical Technology Co.,Ltd	FXX	Class II	2021-08-18
K211957	QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments	Globus Medical, Inc.	NKG	Class II	2021-08-18
K211813	Triton	Inter-Med / Vista Dental	KJJ	Unclassified	2021-08-18
K211631	Surgical Face Mask	Macheng Thimble Technology Investment Co., Ltd.	FXX	Class II	2021-08-18
K211513	sam X1 Long Duration Ultrasound Device	ZetrOZ Systems	PFW	Class II	2021-08-18
K211454	Surgical mask	Jiangsu Xingtong Biotechnology Group Co., Ltd.	FXX	Class II	2021-08-18
K211233	Hailie Sensor NF0109	Adherium (Nz), Ltd.	CAF	Class II	2021-08-18
K210971	EnteraLoc Flow	Vonco Products, LLC	PIF	Class II	2021-08-18
K210318	Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System	Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)	IYN	Class II	2021-08-18
K203227	Elecsys HCG STAT	Roche Diagnostics GmbH	DHA	Class II	2021-08-18