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 2026-11-05, 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 1234 of 3531

510(k) clearances, page 1234 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K062548	Modification to Optimum Gp (Oxygen Permeable) Daily Wear Contact Lenses	Contamac Ltd.	HQD	Class II	2006-11-01
K062323	Deltec Cozmo Insulin Infusion Pump with Cozmonitor Blood Glucose Meter, Models 21-1815, 21-1816, 21-1817	Abbott Medical	LZG	Class II	2006-11-01
K062051	Ss System	OSSTEM Implant Co., Ltd.	DZE	Class II	2006-11-01
K062021	Kowa Vx-10I	Kowa Co., Ltd.	HKI	Class II	2006-11-01
K061830	Stat Profile Critical Care Xpress (Ccx), Model 1+	Nova Biomedical Corporation	CIG	Class II	2006-11-01
K061639	Eclipse Tcd Neurovascular Workstation; Elclipse Neurological Workstation with Tcd and Vascular Doppler; Cardiomon	Axon Systems, Inc.	GWF	Class II	2006-11-01
K063191	Heidelberg Retina Angiograph 2/Optical Coherence Tomograph, Model Hra 2/Oct	Heidelberg Engineering GmbH	OBO	Class II	2006-10-31
K063002	Altra Press-Fit Hip System	Biomet Manufacturing Corp	KWA	Class III	2006-10-31
K062995	M2a-Magnum Tri-Spike Acetabular Component	Biomet Manufacturing Corp	KWA	Class III	2006-10-31
K062863	Osteomed Extended 2.0/2.4Cannulated Screw System	Osteomed	HWC	Class II	2006-10-31
K062861	Ascension Humeral Resurfacing Arthroplasty System	Ascension Orthopedics, Inc.	HSD	Class II	2006-10-31
K062743	Unisight Mammography Viewer, Model 4.0	Electronic Business Machine Co., Ltd. (Ebm)	LLZ	Class II	2006-10-31
K062598	Imt.lab Software	Esaote Europe B.V.	LLZ	Class II	2006-10-31
K062570	Patient Contoured Mesh (Pcm)	KLS-Martin L.P.	GXN	Class II	2006-10-31
K062476	Ceragem Rh1 Automatic Thermal Massager	Ceragem International, Inc.	JFB	Class II	2006-10-31
K062472	Optional Remote Control, Model Rc-115, for Portable X-Ray System, Model Sr-115	Source-Ray, Inc.	IZL	Class II	2006-10-31
K062321	Smartlipo Nd:yag Laser	Cynosure, LLC	GEX	Class II	2006-10-31
K062267	Oxylog 3000	Drager Medical B.V.	CBK	Class II	2006-10-31
K062029	Anatomical Shoulder Fracture System	Zimmer GmbH	KWS	Class II	2006-10-31
K062015	Chronos Vision Eye Tracking Device (C-Etd)	Chronos Vision	GWN	Class II	2006-10-31
K061925	Mini Tightrope Repair Kit, Model Ar-8911Ds	Arthrex GmbH	HTN	Class II	2006-10-31
K061645	Magpro, Model R30	Tonica Elektronik a/S	GWF	Class II	2006-10-31
K063024	Lzi Amphetamine-Specific Oral Fluid Homogeneous Enztme Immunoassay: Lzi Amphetamine Oral Fluid Calibrators and Controls	Lin-Zhi International Inc	DKZ	Class II	2006-10-30
K062967	Cyberknife Robotic Radiosurgery System	Accuray Incorporated	MUJ	Class II	2006-10-30
K062942	Quantimetrix Nicosure Cotinine Urine Control	Quantimetrix Corp.	LAS	Class I	2006-10-30
K061922	Breath Alcohol Test System, Model Al-5000	Sentech Korea Corp.	DJZ	Class I	2006-10-30
K061234	Glucoplus Blood Glucose Monitoring System	Glucoplus, Inc.	NBW	Class II	2006-10-30
K060756	Medlog, Model 1-0-10	Bmc Gesellschaft Fur Medizintechnik mbH	MWI	Class II	2006-10-30
K063113	Ep-Workmate	Abbott Medical	DQK	Class II	2006-10-27
K063107	3Dnet Suite	Biotronics3D, Ltd.	LLZ	Class II	2006-10-27
K063065	Microscan Microstrep Plus Panel Meropenem (0.03-4Mcg/ml)	Siemens Healthcare Diagnostics Inc.	LRG	Class II	2006-10-27
K062860	Modification to Superopen 0.23T, Model Nam-P023a	Neusoft Medical Systems Co., Ltd.	LNH	Class II	2006-10-27
K062778	Sterile Powder-Free Nitrile Patient Examination Glove, Blue Colored	Wear Safe (Malaysia) Sdn Bhd	LZA	Class I	2006-10-27
K062735	Tutu 7, Model IV-T22	Invisible Technology Co., Ltd.	EBZ	Class II	2006-10-27
K062716	Eco-Rx Air Purifier with UV Light, Model Rx-400	Eco-Rx, Inc.	FRA	Class II	2006-10-27
K062653	Mouthkote Oral Moisturizer, Model 50930-098	Parnell Pharmaceuticals, Inc.	LFD	Unclassified	2006-10-27
K062490	Visage Pacs/cs, Release Version 4.1	Mercury Computer Systems, Inc.	LLZ	Class II	2006-10-27
K062477	Amicas Vision Series Pacs, Model 4.3	Amicas, Inc.	LLZ	Class II	2006-10-27
K062438	Bakri Postpartum Balloon, Model J-Sos-100500	Cook Ob/Gyn	KNA	Class II	2006-10-27
K062376	Direct Digital Radiography Ccd Imaging Sensor, Naomi	Rf Systems Lab.	MQB	Class II	2006-10-27
K062068	Intelwave Heart Rate Variability System, Version 1.0	Intelwave, LLC	DPS	Class II	2006-10-27
K062016	Rapid Digital Thermometer, Model Rdt -18 Series	Choice Smart Health Care Co., Ltd.	FLL	Class II	2006-10-27
K062010	Rapid Digital Thermometer, Model Rdt -18 Series	Global Treasure Industries, Ltd.	FLL	Class II	2006-10-27
K061153	Gynesonics Ec6 Transducer	Gynesonics, Inc.	ITX	Class II	2006-10-27
K060889	Se Epiphany Root Canal Sealant, Model N59se	Pentron Clinical Technologies	KIF	Class II	2006-10-27
K060836	Vistadent Oc - Version 4	Dentsply Intl.	LLZ	Class II	2006-10-27
K052267	Supercath V	Togo Medikit Co., Ltd.	FIE	Class II	2006-10-27
K063110	Cst61 High Speed Turbine Handpiece	Shanghai Dental Instrument Factory Co., Ltd.	EFB	Class I	2006-10-26
K063064	Microscan Microstrep Plus Panel Ceftriaxone (0.015-8Mcg/ml)	Siemens Healthcare Diagnostics Inc.	LRG	Class II	2006-10-26
K063053	Microscan Microstrep Plus Panel Cefuroxime (0.12-8 Mcg/ml)	Siemens Healthcare Diagnostics Inc.	LRG	Class II	2006-10-26