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 941 of 3531

510(k) clearances, page 941 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K112555	Cd Horizon(r) Spinal System	Medtronic Sofamor Danek USA Inc	NKB	Class II	2011-09-27
K112371	Logiq P3	GE Healthcare	IYN	Class II	2011-09-27
K112129	Vitek(r) 2 Streptococcus Clindamycin	bioMerieux, Inc.	LON	Class II	2011-09-27
K111951	Isoamp Hsv Assay	Biohelix Corporation	OQO	Class II	2011-09-27
K111837	Radial Artery Compression Tourniquet	Lepu Medical Technology (Beijing) Co., Ltd	DXC	Class II	2011-09-27
K111697	Amo Whitestar Signature Phacoemulsification System	Advanced Medical Optics, Inc.	HQC	Class II	2011-09-27
K111516	Nmr Lipoprofile (R) Test and Nmr Profiler	Liposcience	LBS	Class I	2011-09-27
K110800	Meta-Lock Suture Anchor System	Tarsus Medical, Inc.	MBI	Class II	2011-09-27
K110673	Hi Vision Ascendus Diagnostic Ultrasound Scanner	FUJIFILM Healthcare Americas Corporation	IYN	Class II	2011-09-27
K110290	Exeter Hip Stem	Howmedica Osteonics Corp	JDI	Class II	2011-09-27
K103396	Cool Blood Glucose Monitoring System, Blood Glucose Meter, Cool Control Solution	I-SENS, Inc.	NBW	Class II	2011-09-27
K112524	Hairmax Lasercomb	Lexington International, LLC	OAP	Class II	2011-09-26
K112482	Selectra Slitter Tool	BIOTRONIK AG	DQY	Class II	2011-09-26
K112232	Reprocessed Electrophysiology Catheters	Stryker Sustainability Solutions	NLH	Class II	2011-09-26
K111946	Tephaflex Mesh	Tepha, Inc.	OOD	Class II	2011-09-26
K111880	Spineolgy Peek Bullet Lumber Interbody Fusion Device	Spineology, Inc.	MAX	Class II	2011-09-26
K111845	The Espiner Sac or E Sac	Fannin (UK) Limited	GCJ	Class II	2011-09-26
K111839	Selectra Accessory Kit	BIOTRONIK AG	DQY	Class II	2011-09-26
K111838	Inqu Paste Mix	Isto Technologies, Inc.	MQV	Class II	2011-09-26
K111809	Sl Type Orthodontic Anchor Screws, Spl Type Orthodontic Anchor Screws	Biomaterials Korea Inc.	OAT	Class II	2011-09-26
K111641	Surgicase Orthognathic Software Wizard	Materialise N.V.	LLZ	Class II	2011-09-26
K111614	Centricity Perinatal and Centricity Intensive Care	GE Healthcare	HGM	Class II	2011-09-26
K111496	21.3 Inch (54Cm) Monochrome Digital Mammography Lcd Monitor	Totoku Electric Co., Ltd.	LLZ	Class II	2011-09-26
K111287	Astra Tech Implant System	Astra Tech, Inc.	DZE	Class II	2011-09-26
K110497	Pass Lp Spinal System	Medicrea International	MNH	Class II	2011-09-26
K110462	Kepler Medtec Disposable Bipolar Cable	Kepler Medtec	GEI	Class II	2011-09-26
K112517	Ultraseal Xt Hydro	Ultradent Products Inc.	EBC	Class II	2011-09-23
K112474	Csmc Cardiac Suite- Nuclear Medicine Software	Cedars Sinai Medical Center	KPS	Class II	2011-09-23
K112463	United 36Mm Ceramic Femoral Head, Delta	United Orthopedic Corp.	LZO	Class II	2011-09-23
K112122	Venue 40	GE Healthcare	IYN	Class II	2011-09-23
K112071	Wondfo Cocaine Urine Test Model W10-Cu, W10-P, Wondfo Methamphetamine Urine Test Model W11-Cu, W11-P	Guangzhou Wondfo Biotech Co., Ltd.	DIO	Class II	2011-09-23
K111888	Masimo Lnop/lncs/m-Lncs Multisite-L Oximetry Sensors	Masimo Corporation	DQA	Class II	2011-09-23
K111791	Lumagem Molecular Breast Imaging System	Gamma Medica-Ideas Incorporated	IYX	Class I	2011-09-23
K111649	Cs 7600	Eastman Kodak Company	MUH	Class II	2011-09-23
K111578	Coreleader Colla-Algi Fiber Model Caw	Coreleader Biotech Co., Ltd	FRO	Unclassified	2011-09-23
K111361	Planmed Nuance Excel	Planmeca U.S.A. Inc	MUE	Class II	2011-09-23
K110913	Estech Cobra Surgical System with Thermashield Accessory	Endoscopic Technologies, Inc. D/B/A Estech	OCL	Class II	2011-09-23
K110878	Rhythmview (Tm)	Topera, Inc.	DQK	Class II	2011-09-23
K110572	Mammodiagnost Dr	Philips North America LLC	MUE	Class II	2011-09-23
K103150	Kimberly-Clark Child/pediatric Face Mask	Kimberly-Clark Corporation	OXZ	Class II	2011-09-23
K102938	Acqpoint Thermajade Massage Table	Acqpoint, Inc.	JFB	Class II	2011-09-23
K112645	Radiforce Large Monitor System	Eizo GmbH	DXJ	Class II	2011-09-22
K112455	Aiming Blocks for Variax Distal Radius Plates	Howmedica Osteonics Corp., dba Stryker Orthopaedics	HRS	Class II	2011-09-22
K112448	Pulsioflex	Pulsion Medical Systems AG	DXG	Class II	2011-09-22
K112435	Rhythmlink Monopolar Stimulating Instrument	Rhythmlink International, LLC	ETN	Class II	2011-09-22
K112431	Digital Electrocardiograph	Shenzhen Biocare Electronics Co., Ltd.	DPS	Class II	2011-09-22
K112347	Rapid Intravascular Catheter Start System 22 Gauge / 20 Gauge / 18 Gauge	Vascular Pathways, Inc.	FOZ	Class II	2011-09-22
K112022	Dus-3000/Dus-3000Plus Digital Ultrasonic Diagnostic Imaging System	Advanced Instrumentations, Inc.	IYO	Class II	2011-09-22
K111989	Coronis Fusion 4Mp Dl	Barco N.V.	LLZ	Class II	2011-09-22
K111934	Pd-100 Series Ultrasonic Pocket Doppler	Advanced Instrumentations, Inc.	KNG	Class II	2011-09-22