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 2026-11-02, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 973 of 3531

510(k) clearances, page 973 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K103072	Revere Sacral Plates	Globus Medical, Inc.	NKB	Class II	2011-03-17
K102846	Patient Examination Gloves	Thai Hua Holding Co., Ltd.	LZA	Class I	2011-03-17
K102190	Winstim	Johari Digital Healthcare, Ltd.	IMG	Class II	2011-03-17
K102164	Hemosil Protein S Activity Assay	Instrumentation Laboratory Co.	GGP	Class II	2011-03-17
K110491	Backstop Catheter	Pluromed, Inc.	KOD	Class II	2011-03-16
K110453	Reliance Endoscope Processing System	STERIS Corporation	NZA	Class II	2011-03-16
K110444	Mirage Micro	ResMed Corp	BZD	Class II	2011-03-16
K110412	Ids-Isys Ifg-I Control Set	Immunodiagnostic Systems Ltd.	JJX	Class I	2011-03-16
K110347	Doppler Monitor	Cook Vandergrift, Inc.	DPW	Class II	2011-03-16
K110108	Modalixx	Ampronix, Inc.	LLZ	Class II	2011-03-16
K103773	Zenoflex Dimension	Wieland Dental + Technik GmbH & Co. KG	EIH	Class II	2011-03-16
K103720	Synapse 3D Lung and Abdomen Analysis	FUJIFILM Healthcare Americas Corporation	LLZ	Class II	2011-03-16
K103504	Getinge 400Hc/500hc Series Steam Sterilizer	Getinge Sourcing, LLC	FLE	Class II	2011-03-16
K103384	Escalade Acetabular Cup System	Ortho Development Corp.	LPH	Class II	2011-03-16
K103375	Plumepen Integrated Smoke Evacuation Pencil	Medtek Devices, Inc.	GEI	Class II	2011-03-16
K103265	Nhanes Whole Body Dxa Reference Database	Hologic, Inc.	KGI	Class II	2011-03-16
K103246	Iplan Rt	Brainlab, Inc.	MUJ	Class II	2011-03-16
K102727	Lensar Laser System for Anterior Capsulotomy	LENSAR, Inc	OOE	Class II	2011-03-16
K101947	IVD-Ge02	Sphere Medical, Ltd.	CGA	Class II	2011-03-16
K101374	Aaxter A3 Posterior Spinal System	Aaxter Co., Ltd.	MNH	Class II	2011-03-16
K110018	Fully Automatic Electronic Blood Pressure Monitor	Andon Health Co., Ltd	DXN	Class II	2011-03-15
K103841	Belimed Steam Sterilizer Mst-V	Sauter AG	FLE	Class II	2011-03-15
K103756	Depuy Attune Total Knee System	Depuy Orthopaedics Inc.	OIY	Class II	2011-03-15
K103700	Essential MRI Patient Monitor	Invivo Corporation	DQA	Class II	2011-03-15
K103686	Star 50 N	Larsen & Toubro Limited	MWI	Class II	2011-03-15
K103505	Altum Anterior Cervical Plate	Spinecraft LLC	KWQ	Class II	2011-03-15
K103409	Allergeaze R Clear	Smartpractice	KXF	Class I	2011-03-15
K103404	Ana0tomical Shoulder Tm Combined System	Zimmer GmbH	KWT	Class II	2011-03-15
K102839	Spider Standard and Advanced	Asensus Surgical, Inc.	GCJ	Class II	2011-03-15
K102563	Single Cannula Extended Applicator	Micromedics, Inc.	KYZ	Class I	2011-03-15
K101930	Memometal Navis Bone Plating System	Memometal Technologies	HRS	Class II	2011-03-15
K110458	Silver Antimicrobial Wound Gel	Advanced Medical Solutions Limited	FRO	Unclassified	2011-03-14
K103471	Ubm Plus	Accutome, Inc.	IYN	Class II	2011-03-14
K103156	V.a.c. Veraflo Cleanse Dressing System	Kci USA, Inc. (Kinetic Concepts, Inc.)	OMP	Class II	2011-03-14
K103114	Osspray Sylc Cr	Osspray, Ltd.	EJR	Class I	2011-03-14
K102334	Trans1 Axialif Plus	Trans1 Incorporated	KWQ	Class II	2011-03-14
K102253	Echo Blaster	Telemed	IYO	Class II	2011-03-14
K101552	Foshan Care Medical Nebulizer Model Kywh2001	Foshan Care Medical Technology Co., Ltd.	CAF	Class II	2011-03-14
K101338	Newfix External Fixation System	Technologia Y Diseno Industrial, S.A de C.V	KTT	Class II	2011-03-14
K100698	Stcc	Cardinal Spine, LLC	ODP	Class II	2011-03-14
K110511	E4d Compass	D4D Technologies	LLZ	Class II	2011-03-11
K110389	Stealth 360 Orbital Pad System	Cardiovascular Systems Incorporated	MCW	Class II	2011-03-11
K110343	Tommee Tippee Closer to Nature Electric Breast Pump	Mayborn Baby and Child / Jackel International, Ltd.	HGX	Class II	2011-03-11
K103763	Stellar 300	Larsen & Toubro Limited	MWI	Class II	2011-03-11
K103712	Gryphon Peek Ds Anchor W/ Orthocord, Gryphon Peek Anchor W/ Orthocord	DePuy Mitek, Inc.	HWC	Class II	2011-03-11
K103493	Head Fiation Device (Hfd 100)	Imris, Inc.	HBL	Class II	2011-03-11
K103371	Coude/ or Tiemann	Degania Silicone, Inc.	EZL	Class II	2011-03-11
K103172	Civ-Ob (Plus)	Civnet Communication, Ltd.	HGM	Class II	2011-03-11
K103148	Aida Diagnostic Ultrasound System	Panasonic Healthcare Co., Ltd.	IYO	Class II	2011-03-11
K103146	Isogray Treatment Planning System	Dosisoft	MUJ	Class II	2011-03-11