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 325 of 3528

510(k) clearances, page 325 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K212560	Signature™ ONE System	Orthosoft Inc (D/B/A Zimmer Cas)	QHE	Class II	2021-10-12
K212552	Correx Software	Vilex LLC	KTT	Class II	2021-10-12
K212307	BC Reflex Uni Knee System	Bodycad Laboratories, Inc.	HSX	Class II	2021-10-12
K212116	VBrain-OAR	Vysioneer, Inc.	QKB	Class II	2021-10-12
K211927	Nitrile examination gloves	Fitone Latex Products Co., Ltd. Guangdong	LZA	Class I	2021-10-12
K210845	Disposable Surgical Mask (Model: YYKZ-01)	Jiaxing Amazing Travel-Ware Co., Ltd.	FXX	Class II	2021-10-12
K201514	Child Face Mask	Shandong Shengquan New Material Co., Ltd.	OXZ	Class II	2021-10-10
K212174	STERRAD 100NX Sterilizer with ALLClear Technology	Advanced Sterilization Products	MLR	Class II	2021-10-09
K203750	Straumann CARES P-Series CAD/CAM System	Straumann USA, LLC	NHA	Class II	2021-10-09
K212876	Carescape SpO2 - Masimo	Masimo Corporation	DQA	Class II	2021-10-08
K212520	ProLift Micro Expandable Spacer System	Life Spine	MAX	Class II	2021-10-08
K212479	Cohitech Reusable Tampon Applicator	Cotton High Tech S.L.	HEB	Class II	2021-10-08
K212156	ABCcolla Bone Matrix	Acro Biomedical Co., Ltd.	MQV	Class II	2021-10-08
K212078	Medical Examination Gloves	Guangdong Gymda Medical Technology Co.,Ltd	LZA	Class I	2021-10-08
K211706	Esophageal TTS Stent	Taewoong Medical Co., Ltd.	ESW	Class II	2021-10-08
K211680	Streamline Surgical System	New World Medical, Inc.	MRH	Class II	2021-10-08
K210813	Medical Surgical Mask	Sichuan Pharmaceutical., Inc.	FXX	Class II	2021-10-08
K210622	Single-Use Medical Face Mask	Jiangxi Hongda Medical Equipment Group Ltd.	FXX	Class II	2021-10-08
K210211	PuraStat-OM	3-D Matrix, Inc.	OLR	Unclassified	2021-10-08
K210128	INTEGRA Wound Matrix (Macro-Channels)	Integra LifeSciences Corporation	KGN	Unclassified	2021-10-08
K203688	Clear Aligner	Wuxi EA Medical Instruments Technologies Limited	NXC	Class II	2021-10-08
K203497	Infrared Thermometer (Model K9)	Kangzhan Communication Electronics Co., Ltd.	FLL	Class II	2021-10-08
K201989	B4C System	Braincare Desenvolvimento e Inovacao Tecnologica S.A.	GWM	Class II	2021-10-08
K201210	The Micro Screw System, Micro Screw System Basic	Hager & Meisinger GmbH	DZL	Class II	2021-10-08
K212860	SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit)	STERIS Corporation	FDI	Class II	2021-10-07
K212279	Digital Intraoral X-ray Imaging System	Iray Technology Taicang, Ltd.	MUH	Class II	2021-10-07
K212065	VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger	Remington Medical	DPW	Class II	2021-10-07
K211406	OASIS MRI System	FUJIFILM Healthcare Americas Corporation	LNH	Class II	2021-10-07
K211211	Sterile syringes for single use with/without needle	Azur Medical Company, Inc.	FMF	Class II	2021-10-07
K211077	Surgical Gown	Wujiang Tutaike Textiles & Finishing Co., Ltd.	FYA	Class II	2021-10-07
K210906	IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4	Philips Medizin Systeme Boeblingen GmbH	MHX	Class II	2021-10-07
K210376	Superior Hair Remover	Guangzhou Haoxingwan Technology Co., Ltd.	OHT	Class II	2021-10-07
K210024	NeoMatriX Wound Matrix	Nextgen Biologics, Inc.	KGN	Unclassified	2021-10-07
K212835	AquaBeam Robotic System	PROCEPT BioRobotics Corporation	PZP	Class II	2021-10-06
K212739	ActiFlip	Parcus Medical, L.L.C.	MBI	Class II	2021-10-06
K212191	Adhesive Electrodes	Voncare Medical Device Co Ltd	GXY	Class II	2021-10-06
K212082	Picore	Bio-Med USA, Inc.	GEX	Class II	2021-10-06
K211719	ZinRom Nitrile examination gloves	Changzhou Xingrong Medical Technology Co., Ltd.	LZA	Class I	2021-10-06
K211621	Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)	Careplus (M) Sdn Bhd	KGO	Class I	2021-10-06
K202063	TrusFIL Universal Composite Restorative	Rizhao Huge Biomaterials Company, Ltd.	EBF	Class II	2021-10-06
K212233	RTHawk, HeartVista Cardiac Package	Heartvista, Inc.	LNH	Class II	2021-10-05
K212036	Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy Drugs	Jiangsu Yanfang Medical Technology Co., Ltd.	LZA	Class I	2021-10-05
K211728	Sterile hypodermic syringes for single use	Jiangsu Kangyou Medical Instrument Co., Ltd.	FMF	Class II	2021-10-05
K211508	Steinmann Pins and Kirschner Wires	Stryker Corp.	JDW	Class II	2021-10-05
K211475	Vital Signs Monitors	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	MWI	Class II	2021-10-05
K211429	NAVIPLAN - CT Planning Software for Total Hip Replacement	Naviswiss AG	LLZ	Class II	2021-10-05
K210490	ChM 4.5mm Cortical screws	Chm Sp. Z o.o.	HWC	Class II	2021-10-05
K210406	Bipolar Coagulation Foreceps	Hangzhou AGS MedTech Co., Ltd.	KGE	Class II	2021-10-05
K203288	Cala Trio	Cala Health, Inc.	QBC	Class II	2021-10-05
K203002	SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular System	Bonebridge AG	HRS	Class II	2021-10-05