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 1348 of 3531

510(k) clearances, page 1348 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K034009	Lapex 2000	Meridian AG	NHN	Class II	2005-01-21
K043508	Derma Prene Ultra Powder-Free Polychloroprene Synthetic Surgical Gloves (Chemotherapy Use)	Ansell Healthcare Products LLC	KGO	Class I	2005-01-19
K043382	Tms Full Advantage Full Face Mask, Models Tms-2820, Tms-2830, Tms-2840	Tiara Medical Systems, Inc.	BZD	Class II	2005-01-19
K043281	Charlotte High-Demand Compression Screw	Wrightmedicaltechnologyinc	HWC	Class II	2005-01-19
K043215	Flowcare Plg Cd4 Reagent	Siemens Healthcare Diagnostics Inc.	GKZ	Class II	2005-01-19
K043106	Pinn-Acl Crosspin	Linvatec Corporation	HTY	Class II	2005-01-19
K043060	Omron Fat Loss Monitor with Scale, Model Hbf-400	Omron Healthcare Co., Ltd.	MNW	Class II	2005-01-19
K042961	Spy Intra-Operative Imaging System: Sp2000	Novadaq Technologies ULC	IZI	Class II	2005-01-19
K042745	Lifescreen Apnea	GE Healthcare	MNR	Class II	2005-01-19
K042628	Modification to: Radianalyzer, Model 12711	Radi Medical Systems AB	DQK	Class II	2005-01-19
K042536	Masimo Set Rad 57 Pulse Co-Oximeter	Masimo Corporation	DQA	Class II	2005-01-19
K042108	Vista Plus	Novacor	MLO	Class II	2005-01-19
K043546	Dimension Rxl Max with Streamlab Analytical Workcell and Sample Transfer Module	Siemens Healthcare Diagnostics Inc.	CDT	Class I	2005-01-18
K043472	Medin Tech Zirconia-Cp10, Ss1000	Medin Tech	EIH	Class II	2005-01-18
K043059	Compression Staple and Simple Staple	Wrightmedicaltechnologyinc	JDR	Class II	2005-01-18
K043039	Synthes (USA) External Fixation Component Line Extension - Mr Safe	Synthes (USA) Products LLC	KTT	Class II	2005-01-18
K042898	Panthera N Powder Free Black Nitrile Gloves	Glovco (M) Sdn. Bhd.	LZA	Class I	2005-01-18
K042709	Dover Silver Temperature Sensing Foley Catheter	Tyco Healthcare	EZL	Class II	2005-01-18
K040625	Atad Ard Catheter	Atad Developments, Ltd.	HDY	Class II	2005-01-18
K040103	Soundskin Phototherapy System	Bhc International, Ltd.	GEX	Class II	2005-01-18
K043554	Ultrasound Scanner Mini Focus, Model 1402	BK Medical ApS	IYN	Class II	2005-01-14
K043537	Taperloc 12/14 Taper Femoral Components	Zimmer GmbH	LPH	Class II	2005-01-14
K043536	Navitrack System - S&n Image Free Knee	Orthosoft, Inc.	HAW	Class II	2005-01-14
K043522	Issys Pedicle Screw System	Custom Spine, Inc.	KWP	Class II	2005-01-14
K043502	6 Fr Poly per-Q-Cath Triple Lumen Picc	C.R. Bard Inc	LJS	Class II	2005-01-14
K043402	Thermage Thermacool System	Solta Medical, Inc.	GEI	Class II	2005-01-14
K043304	Q-Cap Needle-Free Reconstitution 13Mm Vial Adapter, Model 6100-01	Bioject Medical Technologies, Inc.	LHI	Class II	2005-01-14
K043263	Trimed Osteotomy Plate	Trimed Inc	HRS	Class II	2005-01-14
K043252	Cabling System Trochanter Hook	Smith & Nephew, Inc.	JDQ	Class II	2005-01-14
K042971	Titan Dental Implant System	Titan Implants, Inc.	DZE	Class II	2005-01-14
K042455	Devilbiss Nasal CPAP Mask, 9354 Series	Sunrise Medical, Inc.	BZD	Class II	2005-01-14
K042168	CONCORD Radiopaque Bone Cement	Globus Medical, Inc.	NDN	Class II	2005-01-14
K033900	X-Static Silverseal Hydrocolloid Film and Island Dressing	Noble Fiber Technologies, Inc.	FRO	Unclassified	2005-01-14
K050034	Sonoline Antares Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	IYN	Class II	2005-01-13
K043557	Model Pc-1000 Panoramic/cephalometric X-Ray Systems	Panoramic Corp.	EHD	Class II	2005-01-13
K043524	Ultrasound Scanner Pro Focus, Model 2202	BK Medical ApS	IYN	Class II	2005-01-13
K043441	Mirage, Release 5.5	Segami Corporation	KPS	Class II	2005-01-13
K043286	Aneroid Sphygmomanometer, Model Bk2002	Wenzhou Bokang Instrument Co.,Ltd	DXQ	Class II	2005-01-13
K043226	Endure Implant, Models 3508, 4308, 3520, 4320	Imtec Corp.	DZE	Class II	2005-01-13
K043135	Spsmedical Sporview Pa Culture Set	Spsmedical Supply Corp.	MRB	Class II	2005-01-13
K043116	Icsi-100	Vitrolife Sweden AB	MQL	Class II	2005-01-13
K042974	Medicon Vipair High Speed System	Medicon, E.G.	HBB	Class II	2005-01-13
K042879	Non-Sterile Powder-Free Blue Nitrile Examination Gloves, with Vanilla Scenting	Sgmp Co., Ltd.	LZA	Class I	2005-01-13
K042849	Cardio Spectrum Diagnostic System (Csd)	Cardiobiomedical Corporation	DQK	Class II	2005-01-13
K042722	Aloclair Oral Spray	Sinclair Pharmaceuticals Ltd	OLR	Unclassified	2005-01-13
K042602	Revolution Xr/d Digital Radiographic Imaging System with Manual Image Pasting	GE Healthcare	MQB	Class II	2005-01-13
K042567	Powderfree Polychloroprene Sterilized Surgical Gloves with Aloe Vera and Vitamin E	PT. Medisafe Technologies	KGO	Class I	2005-01-13
K042512	Vectorvision Acl	Brainlab, Inc.	HAW	Class II	2005-01-13
K042345	Lin/liou Orthodontic Mini Anchor System (Lomas)	Mondeal Medical Systems GmbH	DZE	Class II	2005-01-13
K042254	Pmp4 Selfcheck ECG	Card Guard Scientific Survival, Ltd.	DXH	Class II	2005-01-13