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 1401 of 3531

510(k) clearances, page 1401 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K040797	Britesmile Masking Cream	Britesmile, Inc.	EIE	Class I	2004-04-02
K040742	Modification to Sterrad Sealsure Chemical Indicator Tape	Advanced Sterilization Products	JOJ	Class II	2004-04-02
K040718	Trust	Dhd Healthcare Corp.	CAF	Class II	2004-04-02
K040711	Mesacup Test Pr-3	Rhigene, Inc.	MOB	Class II	2004-04-02
K040665	Somatom Sensation 64 and Sensation Cardiac	Siemens Medical Solutions USA, Inc.	JAK	Class II	2004-04-02
K040566	Resmed Hospital Nasal Mask	ResMed Corp	BZD	Class II	2004-04-02
K040375	Ideal 1 Orthodontic Band Cement	Dentsply Intl.	DYH	Class II	2004-04-02
K040352	Nova-One Lipid Control (Special Low Interference Liquid Lipid Control)	Bioresource Technology	JJY	Class I	2004-04-02
K040264	Calibrator for Automated Systems Proteins in Urine/csf	Roche Diagnostics GmbH	JIX	Class II	2004-04-02
K040234	Laserpro CO2 Carbon Dioxide Laser System	Photo Medex, Inc.	GEX	Class II	2004-04-02
K040197	Eagle Anterior Cervial Plate System	Depuyacromed	KWQ	Class II	2004-04-02
K040012	Well@home System	Zoe Medical, Inc.	DXN	Class II	2004-04-02
K033888	Msi Model S-500 RF Generator	Medsphere International, Inc.	GEI	Class II	2004-04-02
K033875	Atb All-Terrain Balloon Pta Dilatation Catheter	Cook Inc.	DQY	Class II	2004-04-02
K033864	Genzyme Osom Trichomonas Rapid Test	Genzyme Corporation	JWZ	Class I	2004-04-02
K032951	Chrono-Log Whole Blood Aggregometer, Models 591A and 592A	Chrono-Log Corp.	JOZ	Class II	2004-04-02
K031982	Birdsong Leverhaler, Model Lh-1000	Birdsong Medical Devices, Inc.	CAF	Class II	2004-04-02
K031601	Microscan Synergies Plus Gram Negative Mic/combo Panels with Cephalothin (0.5-32 Ug/ml)	Siemens Healthcare Diagnostics Inc.	LON	Class II	2004-04-02
K030139	The Cardiop-B System	Paieon, Inc.	IZI	Class II	2004-04-02
K022828	Osteoset Dbm Pellets, Model 8600-48Xx	Wrightmedicaltechnologyinc	MQV	Class II	2004-04-02
K040633	Click-on	Unomedical A/S	FPA	Class II	2004-04-01
K040553	Modification to Acculeaf	Direx Systems Corp.	IXI	Class II	2004-04-01
K040543	Nuvasive Neurovision Jjb System	NuVasive Inc	ETN	Class II	2004-04-01
K040369	Stryker Consolidated Operating Room Equipment (Core) System	Stryker Corp.	DZJ	Class II	2004-04-01
K040240	Stellartech Coagulation System (Models 1100C-115 & 1100C-230)	Stellartech Research Corp.	GEI	Class II	2004-04-01
K040144	Quixx Posterior Restorative	Dentsply International, Inc.	EBF	Class II	2004-04-01
K040087	Rabbit	Scion International, Inc.	KNW	Class II	2004-04-01
K040081	Palomar Luxv Handpiece	Palomar Medical Technologies, Inc.	GEX	Class II	2004-04-01
K040042	Medisil Silicone Sheeting	Medisil Corporation	MIB	Class II	2004-04-01
K033801	Kyphx Hv-R, Model C01a	Medtronic, Inc.	NDN	Class II	2004-04-01
K033337	Ultrapro Mesh	Ethicon, Inc	FTL	Class II	2004-04-01
K033072	Lucentlite, Model Imd 010	Industrial & Medical Design, Inc.	GEX	Class II	2004-04-01
K032601	Stryker Interventional Pain RF Generator	Valley Forge Scientific Corp.	GXD	Class II	2004-04-01
K032534	Synthes Afs	Synthes GmbH	NQW	Class II	2004-04-01
K032406	Stryker RF Electrodes and Cannulae	Stryker Corp.	GXI	Class II	2004-04-01
K030989	Osteosorb Tack Fixation System	Noviace Corporation	JEY	Class II	2004-04-01
K030784	Nasogastric Bridle System with Magnetic Retrieval	Applied Medical Technology Inc	KNT	Class II	2004-04-01
K024186	X-View	Sometech Corporation	MUH	Class II	2004-04-01
K040596	Ultrasound Imaging System, Model 7300	Esaote S.p.A.	IYN	Class II	2004-03-31
K040594	Herculon Soft Tissue Reattachment System	United States Surgical, A Division of Tyco Healthc	HWC	Class II	2004-03-31
K040583	Modification to: Cd Horizon Spinal System	Medtronic Sofamor Danek	MNI	Class II	2004-03-31
K040561	Manual Wheelchair Series	Shanghai Wheelchair Factory	IOR	Class I	2004-03-31
K040297	Oneuse- Plus Microkeratome	Moria SA	HMY	Class I	2004-03-31
K040083	Synthes External Midface Distractor	Synthes (USA) Products LLC	MQN	Class II	2004-03-31
K040080	Aesculap Absorbable Craniofix	Aesculap Inc	GXR	Class II	2004-03-31
K033979	Corlink Automated Anastomotic System	By-Pass Makafim, Ltd.	FZP	Class II	2004-03-31
K033901	Merlin Spine System	DePuy Spine, Inc.	NKB	Class II	2004-03-31
K033702	Blackstone Peek Vertebral Body Replacement System	Blackstone Medical, Inc.	MQP	Class II	2004-03-31
K033645	Otoflex 100 Tye 1012	Natus Medical Denmark ApS	ETY	Class II	2004-03-31
K033074	Inion Gtr Biodegradable Membrane System	Inion Oy	NPK	Class II	2004-03-31