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 323 of 3528

510(k) clearances, page 323 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K210348	Disposable Medical Surgical Mask	Weihai Dishang Medical Technology Co.,Ltd	FXX	Class II	2021-10-24
K212666	Neuromark System	Neurent Medical Inc.	GEI	Class II	2021-10-22
K212516	IRNF App	Apple Inc.	QDB	Class II	2021-10-22
K212399	Aveli	Nc8, Inc.	OUP	Class II	2021-10-22
K212396	UroLift System Rigid Retrieval Kit Sterilization Tray	Neotract Inc	KCT	Class II	2021-10-22
K212200	STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette	Plasmapp Co., Ltd.	MLR	Class II	2021-10-22
K212198	Tyvek(R) Roll with CI for STERLINKTM Sterilizer	Plasmapp Co., Ltd.	FRG	Class II	2021-10-22
K212193	Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)	Plasmapp Co., Ltd.	FRC	Class II	2021-10-22
K212061	EnSite X EP System	Abbott Medical	DQK	Class II	2021-10-22
K211819	DiLumen C2 and Tool Mount	Lumendi, LLC	FDF	Class II	2021-10-22
K211775	Cohitech Organic Cotton Non-Applicator Cottonlock Tampons	Cotton High Tech S.L.	HEB	Class II	2021-10-22
K211735	CO2 Laser Machine, Model: BW-203B	Zhengzhou Bestview ST Co., Ltd.	GEX	Class II	2021-10-22
K211186	Erchonia XLR8	Erchonia Corporation	NHN	Class II	2021-10-22
K210807	FlightPlan for Liver	GE Medical Systems SCS	LLZ	Class II	2021-10-22
K210424	Quantum Anterior Cervical Plate	Nvision Biomedical Technologies, Inc	KWQ	Class II	2021-10-22
K210310	CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit	Nuance Medical, LLC	GEH	Class II	2021-10-22
K202120	P300 Attachment	Nakanishi Inc.	HBE	Class II	2021-10-22
K213113	Orthoscan Tau Mini C-Arm	Orthoscan, Inc.	OXO	Class II	2021-10-21
K213036	Treace Medical Concepts (TMC) Screw Fixation System	Treace Medical Concepts, Inc.	HWC	Class II	2021-10-21
K213028	Tenax Laser Resistant Endotracheal Tube	Bryan Medical Inc	BTR	Class II	2021-10-21
K212314	IPL Hair Removal Device	Zhongshan Bisen Plastic Electronic Products Co.,Ltd	OHT	Class II	2021-10-21
K212311	Medical Examination Gloves	Guangzhou Junda Gloves Co., Ltd.	LZA	Class I	2021-10-21
K212270	DEKA LipoAI	El.en. Electronic Engineering SpA	GEX	Class II	2021-10-21
K211526	Portable Scalp Cooling System	Cooler Heads Care, Inc.	PMC	Class II	2021-10-21
K211415	GR Splint Resin System	PRO3DURE Medical GmbH	MQC	Unclassified	2021-10-21
K211407	Belun Ring BLR-100X	Belun Technology Company Limited	DQA	Class II	2021-10-21
K211171	CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories	GE Healthcare Finland Oy	CCK	Class II	2021-10-21
K210928	PENTAX Medical Video Bronchoscope EB11-J10	PENTAX of America, Inc.	EOQ	Class II	2021-10-21
K210322	XO Cross Support Catheter	Transit Scientific, LLC	DQY	Class II	2021-10-21
K200545	Legend Pro DMA	Pollogen Ltd	NGX	Class II	2021-10-21
K212490	AVVIGO Guidance System II	Boston Scientific Corporation	DQK	Class II	2021-10-20
K212470	iRAD	Claritas Healthtech Limited	LLZ	Class II	2021-10-20
K212427	cobas Cdiff nucleic acid test for use on the cobas Liat System	Roche Molecular Systems Inc	OZN	Class II	2021-10-20
K211921	S.I.N. Dental Implant System	S.I.N. Implant System Ltda	DZE	Class II	2021-10-20
K211672	MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL	Liofilchem S.r.l.	JWY	Class II	2021-10-20
K210789	Eq-Pex	Meta Systems Co., Ltd.	LQY	Unclassified	2021-10-20
K210632	Contour ProtegeAI	MIM Software Inc	QKB	Class II	2021-10-20
K210618	Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series	Chongqing Jinshan Science & Technology Co., Ltd.	OCX	Class II	2021-10-20
K210511	InTray GC	Biomed Diagnostics Incorporated	JTY	Class II	2021-10-20
K210177	PENTAX Medical Video Upper GI Scopes EG17-J10	PENTAX of America, Inc.	FDS	Class II	2021-10-20
K203808	Multi-unit Abutment, Multi-unit Angled Abutment	Megagen Implant Co., Ltd.	NHA	Class II	2021-10-20
K200865	Piccolo Potassium Test System	Abaxis Inc	MZV	Class II	2021-10-20
DEN210005	Luminopia One	Luminopia Inc	QQU	Class II	2021-10-20
K212703	AcuPulse CO2 Laser System, Delivery Devices and Accessories	Lumenis Ltd	GEX	Class II	2021-10-19
K212254	DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)	HDX Will	OAS	Class II	2021-10-19
K211564	Sterile High-pressure Angiographic Syringes for Single-use	Shenzhen Boon Medical Supply Co., Ltd.	DXT	Class II	2021-10-19
K211170	Single Use Irrigation bipolar cable	Modern Medical Equipment Manufacturing Ltd.	GEI	Class II	2021-10-19
K211084	Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope	Shanghai Caremate Medical Device Co. Ltd	DXQ	Class II	2021-10-19
K211035	U9000 Plus Ultrafilter	Baxter Healthcare Corporation	FIP	Class II	2021-10-19
K210911	WOLF Thrombectomy System, 14F	Devoro Medical, Inc.	QEW	Class II	2021-10-19