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 2026-10-12, 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 251 of 3528

510(k) clearances, page 251 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K213919	Dexcom G7 Continuous Glucose Monitoring System	Dexcom, Inc.	QBJ	Class II	2022-12-07
K212567	PVC Hydrophilic Urethral Catheter	Chengdu Daxan Innovative Medical Tech. Co., Ltd.	EZD	Class II	2022-12-07
K223632	Premier's MultiMatch Universal Chameleon Restorative Composite	Premier Dental Products Co	EBF	Class II	2022-12-06
K223409	Cios Select (VA21) Image Intensifier	Siemens Medical Solutions USA, Inc.	OWB	Class II	2022-12-06
K223386	Optima Coil System	Balt USA, LLC	HCG	Class II	2022-12-06
K223247	Swoop Portable MR Imaging System	Hyperfine, Inc	LNH	Class II	2022-12-06
K222706	iCE-SG2 Subcutaneous Electrode Kit	Ice Neurosystems, Inc.	GZL	Class II	2022-12-06
K222626	Dental Zirconia Ceramic	Aidite (Qinhuangdao) Technology Co., Ltd	EIH	Class II	2022-12-06
K222575	HurriChem Device Kit	Thermasolutions LLC.	GCJ	Class II	2022-12-06
K222541	Bausch + Lomb Preservative Free Lubricating and Rewetting Drops	Bausch & Lomb Incorporated	LPN	Class II	2022-12-06
K222385	Bifurcated Needle	Anhui Tiankang Medical Technology Co., Ltd.	SCL	Class II	2022-12-06
K222320	MedDream	Softneta UAB	LLZ	Class II	2022-12-06
K222219	R2 Studio Q/RCT820	Megagen Implant Co., Ltd.	OAS	Class II	2022-12-06
K221021	Femoral Trochanteric Nail System – Neonail	Neoortho Produtos Ortopedicos S/a	HSB	Class II	2022-12-06
K223055	Disposable Medical Face Mask	Xiantao Zhuobo Industrial Co., Ltd.	FXX	Class II	2022-12-05
K222692	BriefCase	Aidoc Medical Ltd.	QFM	Class II	2022-12-05
K222689	Mallya Injection Pen Adapter (Mallya® for Solostar®)	Biocorp Production	QOG	Class II	2022-12-05
K222681	Altaviz Needle Kit	Altaviz, LLC	FMI	Class II	2022-12-05
K222669	Cryopush Cold Compression Device	Chengdu Cryo-Push Medical Technology Co.,Ltd	IRP	Class II	2022-12-05
K222614	Zavation Spinal System	Zavation Medical Products, LLC	NKB	Class II	2022-12-05
K222137	OK Plus Indicator	Propper Manufacturing Co., Inc.	JOJ	Class II	2022-12-05
K221806	TruLift Lateral Expandable Spacer System & Lateral Plate System	Life Spine	MAX	Class II	2022-12-05
K221612	ClearRead CT	Riverain Technologies	OEB	Class II	2022-12-05
K213169	BPAP System	BMC Medical Co., Ltd.	MNS	Class II	2022-12-05
K223004	Disposable Nitrile Examination Gloves	Jiangxi Handspro Products Solutions Co., Ltd.	LZA	Class I	2022-12-04
K222815	Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl	Zibo Lanhua Medical Packaging Material Co., Ltd	LZA	Class I	2022-12-04
K222019	Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)	Stryker Sustainability Solutions	NLF	Class II	2022-12-04
K222720	Blue Nitrile Powder Free Patient Examination Glove, Non Sterile	Safeskin Retailing (Hk) Limited	LZA	Class I	2022-12-03
K222715	Black Nitrile Powder Free Patient Examination Glove, Non Sterile	Safeskin Retailing (Hk) Limited	LZA	Class I	2022-12-03
K222713	White Nitrile Powder Free Patient Examination Glove, Non Sterile	Safeskin Retailing (Hk) Limited	LZA	Class I	2022-12-03
K212866	truSculpt flex	Johari Digital Healthcare, Ltd.	NGX	Class II	2022-12-03
K223369	truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184	STERIS Corporation	GEH	Class II	2022-12-02
K223353	DropSafeTM SicuraTM	PIKDARE S.p.A.	FMI	Class II	2022-12-02
K223218	Parietene Macroporous Mesh	Sofradim Production	FTL	Class II	2022-12-02
K223211	INHANCETM Shoulder System – Humeral Stems and Stemless	Depuy Ireland UC	PHX	Class II	2022-12-02
K223072	PENTAX Medical Video Esophagoscope EE17-J10	PENTAX of America, Inc.	EOX	Class II	2022-12-02
K221590	NaviCam Small Bowel Capsule Endoscopy System	Ankon Technologies Co., Ltd.	NEZ	Class II	2022-12-02
K221410	Maestro Platform	Moon Surgical, Inc.	FQO	Class I	2022-12-02
K221401	Self-Cath and Self-Cath Plus	MEDLINE INDUSTRIES, LP - Northfield	EZD	Class II	2022-12-02
K221141	PageWriter TC35 Cardiograph	Medizin Systeme Boblingen GmbH	DPS	Class II	2022-12-02
K221113	Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	MWI	Class II	2022-12-02
K220778	Chemical Indicator for Steam	True Indicating LLC	JOJ	Class II	2022-12-02
K220688	SilentZPro 2.0	Shinrin-Yoku Traders LLC	LRK	Class II	2022-12-02
K220611	SUREcore Plus Biopsy Instrument	Uro-1, Inc.	KNW	Class II	2022-12-02
K220390	CreoDent Solidex Customized Abutment and Screw	Creodent Prosthetics Ltd	NHA	Class II	2022-12-02
K213465	CardioGraphe	Arineta Ltd.	JAK	Class II	2022-12-02
K223226	Trigon™ HA Stand-Alone Wedge Fixation System	Nvision Biomedical Technologies, Inc	PLF	Class II	2022-12-01
K222710	IPL Cooling Hair Removal Device	Shenzhen Siken 3D Technology Development Co., Ltd.	OHT	Class II	2022-12-01
K222516	Mercury® II Spinal System	Spinal Elements, Inc	NKB	Class II	2022-12-01
K222368	Mist Ic	Imagine Milling Technologies, LLC	NHA	Class II	2022-12-01