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 248 of 3528

510(k) clearances, page 248 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K222351	inspired™ VHB20 Heated Humidifier	Vincent Healthcare Products Limited	BTT	Class II	2022-12-21
K222234	GlucoSure ADVANCE Link Blood Glucose Monitoring System	Apex Biotechnology Corp.	NBW	Class II	2022-12-21
K221911	Vinno 6Pro, Vinno 6Exp, Vinno 5Pro, Vinno 5Exp, Vinno 3, Vinno 3Pro, Vinno 3Exp	Vinno Technology (Suzhou) Co.,Ltd	IYN	Class II	2022-12-21
K221902	LimFlow Vector	LimFlow Inc.	MGZ	Class II	2022-12-21
K221826	BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)	Becton Dickinson & Co	JTN	Class II	2022-12-21
K221720	Extra Silver Gelling Fiber Dressing	Winner Medical Co., Ltd.	FRO	Unclassified	2022-12-21
K221698	Eargo 5 , Eargo 6	Eargo Inc	QUH	Class II	2022-12-21
K221221	Advanced Intramedullary Nail System	Double Medical Technology Inc.	HSB	Class II	2022-12-21
K221054	Core-Injector	Incore Co., Ltd.	FBK	Class II	2022-12-21
K220286	ELECTROCYN soma	V3BIO Sdn. Bhd.	FRO	Unclassified	2022-12-21
K220012	BresoDX1	Bresotec, Inc.	MNR	Class II	2022-12-21
K213893	Comfort Gown, Safewear Gown	Xuchang Zhengde Environstar Medical Products Co.,Ltd.	FYA	Class II	2022-12-21
K213875	DRI TM Tricyclics Serum Tox Assay	Microgenics Corporation	LFH	Class II	2022-12-21
K213564	BiWaze Clear System	Abmrc LLC	NHJ	Class II	2022-12-21
K213235	PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System	PENTAX of America, Inc.	EOQ	Class II	2022-12-21
K202965	CURA-Temp	Mgnewton Ltd.	EBG	Class II	2022-12-21
K223294	SpineJack® Expansion Kit	Stryker Corp.	NDN	Class II	2022-12-20
K223140	AEON-C™ Stand Alone System	Dio Medical Co., Ltd.	OVE	Class II	2022-12-20
K222896	AirRay	Poskom Co., Ltd	IZL	Class II	2022-12-20
K222808	Penumbra System (Reperfusion Catheter RED 43)	Penumbra Inc.	NRY	Class II	2022-12-20
K222405	Smart SPACE Shoulder Planner and 3D Positioners	Lima Corporate S.p.A.	QHE	Class II	2022-12-20
K222358	Indigo Aspiration System - Lightning Flash	Penumbra Inc.	QEW	Class II	2022-12-20
K222308	Al Smile Aligner	Nanjing Jiahe Dental Technology Co., Ltd.	NXC	Class II	2022-12-20
K221926	Invictus® Bone Cement, Invictus Spinal Fixation System	Alphatec Spine, Inc.	PML	Class II	2022-12-20
K221904	EK12 V2 Algorithm	GE Medical Systems Information Technologies, Inc.	MHX	Class II	2022-12-20
K221775	LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)	Light Tree Ventures Europe B.V.	OHS	Class II	2022-12-20
K221735	Mineral Collagen Composite Bioactive Moldable	Collagen Matrix, Inc	MQV	Class II	2022-12-20
K221603	Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (B5FD );Kangaroo OMNI™ ENtelliSet 500ml (E5FD );Kangaroo OMNI™ Feeding Set 1000ml (B10FD );Kangaroo OMNI™ ENtelliSet 1000ml (E10FD );Kangaroo OMNI™ ENPlus Spike Set (BSPFD );Kangaroo OMNI™ ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI™ Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI™ ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI™ Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI™	Medtronic, Inc.	LZH	Class II	2022-12-20
K221070	DP4 Microneedling device	Equipmed USA LLC	QAI	Class II	2022-12-20
K221039	Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y	Shenzhen AOJ Medical Technology Co., Ltd.	FLL	Class II	2022-12-20
K221031	Arthrex DualCompression Hindfoot Fusion Nail Implant System	Arthrex GmbH	HSB	Class II	2022-12-20
K221011	AI.ME System	Venus Concept USA Inc.	QAI	Class II	2022-12-20
K221004	HOPKINS Telescopes	Karl Storz Endoscopy-America, Inc.	GCJ	Class II	2022-12-20
K220991	IntelliSep test	Cytovale, Inc.	QUT	Class II	2022-12-20
K220517	IBS System	Innobiosurg Co., Ltd.	DZE	Class II	2022-12-20
K213677	Bonafix 2 Plus	Zentek Medical LLC	DZE	Class II	2022-12-20
K222919	GORE® ENFORM Biomaterial	W. L. Gore & Associates, Inc.	OXF	Class II	2022-12-19
K222217	ViewFlex Xtra Reprocessed ICE Catheter	Abbott Medical	OWQ	Class II	2022-12-19
K222213	Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)	Unimed Medical Supplies Inc	DQA	Class II	2022-12-19
K221896	BreathID Hp System	Meridian Bioscience Israel Ltd.	MSQ	Class I	2022-12-19
K221351	Mechanical Guidewire	Baylis Medical Co., Inc.	DQX	Class II	2022-12-19
K214076	EsCem	Spident Co., Ltd.	EMA	Class II	2022-12-19
K213653	4Cis Black Marlin Plif Cage System, 4Cis Dolphin Tlif Cage System	Solco Biomedical Company India Private Limited	MAX	Class II	2022-12-19
K213196	MARVEL™ Growing Rods	Globus Medical, Inc.	PGM	Class II	2022-12-19
K220881	Inoue Balloon a	Toray Industries, Inc.	OZT	Class II	2022-12-18
K223334	Sterile Hypodermic Needles for Single Use	Zhejiang Kindly Medical Devices Co., Ltd.	FMI	Class II	2022-12-16
K223268	BrainInsight	Hyperfine, Inc	QIH	Class II	2022-12-16
K223251	Hexanium PLIF	Spinevision SAS	MAX	Class II	2022-12-16
K223243	BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel™ Lancets	Becton Dickinson & Co	FMK	Class II	2022-12-16
K223237	SofWave System	Sofwave Medical Ltd.	OHV	Class II	2022-12-16