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 1301 of 3531

510(k) clearances, page 1301 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K052449	Cadman Integrated Irrigation Tubing and Bipolar Cord Set, Models 80-1163, 80-1189	Cerenovus, Inc.	GEI	Class II	2005-10-17
K052443	Icy Catheter, Model Ic-3893A	Alsius Corp.	NCX	Class II	2005-10-17
K052368	Olecranonplate with Angular Stability	I.T.S. Implantat-Technologie-Systeme GmbH	HRS	Class II	2005-10-17
K052365	Cervineedle Disposable Cartridge Syringe	Rocket Medical	HEE	Class II	2005-10-17
K052351	Hdr Iort Shielded Applicator	Mick Radio-Nuclear Instruments, Inc.	JAQ	Class II	2005-10-17
K052284	Reformat Gateway	Infinitt Co., Ltd.	LLZ	Class II	2005-10-17
K052189	Reveneer Ceramic Repair System	Schutz-Dental GmbH	KLE	Class II	2005-10-17
K052175	I-Stop Mid-Urethral Sling, Models Is-1000, Is-2000, Is-3000, Is-4000	Uroplasty, LLC	OTN	Class II	2005-10-17
K052124	Acticlot, Model 824	Sekisui Diagnostics, LLC	GJS	Class II	2005-10-17
K052043	3.8Mm Cs Facet Compression Device	Triage Medical, Inc.	MRW	Unclassified	2005-10-17
K052025	Urgent Pc Neuromodulation System	Uroplasty, LLC	NAM	Class II	2005-10-17
K051976	Proven Revision Modular Tibial Tray	Globus Medical, Inc.	JWH	Class II	2005-10-17
K051815	Modification to Vertebron Scp Cervical Plate System	Vertebron, Inc.	KWQ	Class II	2005-10-17
K051543	Elecsys Precicontrol Bone	Roche Diagnostics GmbH	JJY	Class I	2005-10-17
K051531	Tectonic Cervical Plate System	K2M, Inc	KWQ	Class II	2005-10-17
K042352	Bioderm Sciences Wound Cream	Bioderm Sciences, Inc.	FRO	Unclassified	2005-10-17
K041704	Newgel and Newgel Plus E	Newmedical Technology, Inc.	MDA	Class I	2005-10-17
K052582	Datex-Ohmeda S/5 Single-Width Airway Module, E-Minic and Accessories	GE Healthcare	CCK	Class II	2005-10-14
K052463	Prometal Hn86	Prometal Technologies	EJT	Class II	2005-10-14
K052085	Standard, Special, Special+, Sneedle B-Type and Sneedle J-Type Acupuncture Needles	Asia-Med GmbH and CO KG	MQX	Class II	2005-10-14
K052070	Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis Gemeini + Abutment in Zirconia	Atlantis Components, Inc.	NHA	Class II	2005-10-14
K051705	Ips E.max Cad/ips E.max Zircad	Ivoclar Vivadent, Inc.	EIH	Class II	2005-10-14
K050970	Milo Dental Implant System	Intra-Lock International	DZE	Class II	2005-10-14
K050265	Chrono-Log Whole Blood Lumi-Aggregometer, Model 700	Chrono-Log Corp.	JOZ	Class II	2005-10-14
K052755	Datex-Ohmeda S/5 Nellcor Compatible Saturation Module, E-Nsat	GE Healthcare	DQA	Class II	2005-10-13
K052600	Zimmer Dental Hex-Lock Prepared Abutment (Straight & Angled)	ZimVie US Corp LLC	NHA	Class II	2005-10-13
K052552	Hybrid Anterior Cervical Plate System	DePuy Spine, Inc.	KWQ	Class II	2005-10-13
K052547	Belmont Buddy Fluid Warmer	Belmont Medical Technologies	BSB	Class II	2005-10-13
K052366	Etest Tigecycline Gram Positive and Gram Negative Aerobic Bacteria, Streptococcus Spp. and Anaerobic Bacteria	Ab Biodisk	JWY	Class II	2005-10-13
K052244	Iisis, Version 1.0	Innovision Medical Technologies, LLC	MOD	Class II	2005-10-13
K052171	Zimmer Ambulatory Pump Pain Management System with Patient Control Module	Zimmer GmbH	FRN	Class II	2005-10-13
K051805	Kendall Scd Sleeves (Extra Large Knee, Extra Large Thigh), Kendall Scd Lexpres Sleeves (Extra Large Knee, Extra Large	Tyco Healthcare/Kendall	JOW	Class II	2005-10-13
K051645	Evis Exera 160A System	Olympus Medical Systems Corp.	NWB	Class II	2005-10-13
K051626	Immunalysis Opiates Elisa for Oral Fluids	Immunalysis Corporation	DJG	Class II	2005-10-13
K052677	Synthes Universal Locking Trochanter Stabilization Plate (Ultsp)	Synthes (USA) Products LLC	HRS	Class II	2005-10-12
K052658	Selectflow - Intravascular Administration Set	Renascence Medical, Inc.	FPA	Class II	2005-10-12
K052497	Neurovascular Array Coil, Model Nva-127-16-a	Invivo Corporation	MOS	Class II	2005-10-12
K051977	Scorpio Knee System Tibial Inserts and Patellar Components	Howmedica Osteonics Corp	JWH	Class II	2005-10-12
K051959	Nv Cormed Solas Spinal System	Nv Cormed	MNH	Class II	2005-10-12
K051928	Autocheck6+	Radiometer Medical ApS	JJY	Class I	2005-10-12
K051480	Enteral Feeding Tube	Biosearch Medical Products, Inc.	BSS	Class II	2005-10-12
K052761	Modification to: Xia 4.5 Spinal System	Howmedica Osteonics Corp	MNI	Class II	2005-10-11
K052634	Teh Loong Powdered Synthetic Vinyl Patient Examination Gloves, White	Teh Loong Corp.	LYZ	Class I	2005-10-11
K052528	Aoc Bone Wax Ostene, Osteotene and Ceretene	Ceremed, Inc.	MTJ	Unclassified	2005-10-11
K052495	Atrilaze Malleable Ablation Probe	Medical Cv, Inc.	GEX	Class II	2005-10-11
K052440	Mentor Self-Cath Hydrogel Intermittent Catheter	Mentor	EZD	Class II	2005-10-11
K052336	Spectraquattro Pulsed Light System	Amjet Distribution, LLC	GEX	Class II	2005-10-11
K052279	Cook Ireland Echobrush	Cook Ireland Ltd.	FDX	Class II	2005-10-11
K052163	Advia Ims Glucose Assay	Medrad, Inc.	CFR	Class II	2005-10-11
K052003	Vnus Rfs, Model Rfs-6-Xx (Xx = 10, 12, 13, & 15); Vnus Rfs Flex, Model Rfx-6-Xx (Xx = 10, 20, 30 & 40)	Vnus Medical Technologies, Inc.	GEI	Class II	2005-10-11