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 1236 of 3531

510(k) clearances, page 1236 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K062695	Sagemax Z-Blank	Sagemax Bioceramics, Inc.	EIH	Class II	2006-10-20
K062647	E-View Fluoroscopy System, Model Cs-50	Omega Medical Imaging, LLC	OWB	Class II	2006-10-20
K062450	D-Spect Cardiac Scanner System	Spectrum Dynamics, Ltd.	KPS	Class II	2006-10-20
K062295	Iri Integrated Retinal Imager	Medivision Medical Imaging, Ltd.	HKI	Class II	2006-10-20
K062251	Reflexion Spiral Variable Radius Catheter, Model 402804	Abbott Medical	DRF	Class II	2006-10-20
K062202	Occlusion Balloon	Boston Scientific Corporation	DQY	Class II	2006-10-20
K062156	Super Orthodontic Screw	OSSTEM Implant Co., Ltd.	DZE	Class II	2006-10-20
K062147	Integra Sl	Direx Systems Corp.	LNS	Class II	2006-10-20
K062129	P.0004 Implants	Straumann USA, LLC	DZE	Class II	2006-10-20
K061651	Fischer Cone Biopsy Excisor, Models 900-150, 151, 152, 154, 155, 157 and 158	CooperSurgical, Inc.	HGI	Class II	2006-10-20
K063047	Medhot Mti 2000 Thermal Imaging System	Medhot Thermal Imaging, Inc.	LHQ	Class I	2006-10-19
K062831	Modification to Life Spine Neo Anterior Cervical Plate System	Life Spine	KWQ	Class II	2006-10-19
K062774	Belmont Buddy Plus Fluid Warmer	Belmont Medical Technologies	BSB	Class II	2006-10-19
K062564	Synthes Lcp Distal Femur Plates	Synthes (USA) Products LLC	HRS	Class II	2006-10-19
K062519	Nexus 3	Kerr Corporation	EMA	Class II	2006-10-19
K062496	Osteopore Tcp	Spinecraft LLC	MQV	Class II	2006-10-19
K062494	Ebi Optilock Upper Extremity Plating System	Ebi, LLC	HRS	Class II	2006-10-19
K062418	K-Spray, Model 085-2715	Scican Ltd.	EFB	Class I	2006-10-19
K062352	Frs Screw	Depuy Orthopaedics Inc.	HWC	Class II	2006-10-19
K062336	Optimedica Laser Indirect Ophthalmoscope	OptiMedica Corp.	GEX	Class II	2006-10-19
K062125	Superstitch 5F, 12F, and El	Sutura, Inc.	GAW	Class II	2006-10-19
K062079	Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210	Baxter Healthcare Corporation	KDI	Class II	2006-10-19
K061863	Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family	Arthrex GmbH	HWC	Class II	2006-10-19
K061681	Repicci II Metal Back Inlay Unicompartmental Tibial Bearing Component	Biomet Manufacturing Corp	HRY	Class II	2006-10-19
K060967	Niobe Magnetic Navigation System W/navigant Workstation	Stereotaxis Inc	NDQ	Class II	2006-10-19
K063877	Syngo Lung Cad	Siemens Medical Solutions USA, Inc.	OEB	Class II	2006-10-18
K063097	Enseal Ptc Tissue Sealing Device	Surgrx, Inc.	GEI	Class II	2006-10-18
K063037	Centarisone Ris/pacs	Centarisone, LLC	LLZ	Class II	2006-10-18
K062949	Enseal Ptc Tissue Seating Sealing Device	Surgrx, Inc.	GEI	Class II	2006-10-18
K062864	Mastalex -Mrsa, Model Rst501	Mast Group Ltd.	MYI	Class II	2006-10-18
K062809	Admiral Xtreme Pta Catheter	Invatec Innovative Technologies, S.r.l.	DQY	Class II	2006-10-18
K062786	Modification to Given Diagnostic System	Given Imaging Ltd.	NEZ	Class II	2006-10-18
K062540	Nasopore Ear, Models Nd04, Nd05	Polyganics B.V.	KCN	Class I	2006-10-18
K062305	Clarity Modified Ceramic Brackets	3M UNITEK Corporation	NJM	Class II	2006-10-18
K062268	Masimo Set Spo2 Module for Philips and M3001a Multi-Measurement Server Option A03	Philips North America LLC	DQA	Class II	2006-10-18
K062090	Prisma System R03.10a	Gambro Renal Products	KDI	Class II	2006-10-18
K062080	Resuscitation Timer, Model L770-CPR	Allied Medical LLC	BTM	Class II	2006-10-18
K062005	Portex Epidural Catheter	Abbott Medical	BSO	Class II	2006-10-18
K061842	Quanta Lite Pbc Screen Igg/iga Elisa	Inova Diagnostics, Inc.	NRI	Class II	2006-10-18
K061661	Sta Cath Attachable Infision Catheter, Model Sta20	Advanced Infusion, Inc.	MEB	Class II	2006-10-18
K061549	Amniostat-Flm-Pg	FUJIFILM Biosciences Inc.	JHG	Class II	2006-10-18
K061411	Torbot Vascular Compression Garments	Torbut Group, Inc.	DWL	Class II	2006-10-18
K061359	Denshield Treatment for Sensitive Teeth	Novamin Technology, Inc.	LBH	Class II	2006-10-18
K060204	Liaison Ea Igg	Diasorin Inc.	LSE	Class I	2006-10-18
K063007	Powertome Periotome	Westport Medical, Inc.	EKX	Class I	2006-10-17
K062843	Fox Sv Pta Catheter	Abbott Medical	LIT	Class II	2006-10-17
K062810	Solitaire Anterior Spinal System	Ebi, LLC	MQP	Class II	2006-10-17
K061172	Pajunk Multistim Sensor Nerve Stimulators	Pajunk GmbH Medizintechnologie	BXN	Class II	2006-10-17
K063032	Comfort Scooter, Model Ly-Ew415	Comfort Orthopedic Co., Ltd.	INI	Class II	2006-10-16
K062959	Dms 300-2, 300-3 and 300-4	Diagnostic Monitoring Software	MWJ	Class II	2006-10-16