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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 775 of 3530

510(k) clearances, page 775 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K133519	Carolina Liquid Chemistries Clc 6410 Chemistry Analyzer; Carolina Liquid Chemistries Glucose Reagent, Car	Carolina Liquid Chemistries	JJE	Class I	2014-05-16
K133257	Biopsy Pipettes	Research Instruments Ltd	MQH	Class II	2014-05-16
K132694	Nuvasive Nvm5 System	Nu Vasive, Incorporated	PDQ	Class II	2014-05-16
K132037	Vital Signs Monitor	Mindray North America	MWI	Class II	2014-05-16
K131096	Ar1000 Series Ultrasonic Wound Therapy System	Arobella Medical, LLC	NRB	Class II	2014-05-16
K141093	6Vt-D Ultrasound Transducer	GE Vingmed Ultrasound AS	ITX	Class II	2014-05-15
K140952	Charlotte Carolina Jones Fracture System Screw	Wrightmedicaltechnologyinc	HWC	Class II	2014-05-15
K140741	Salvation Beams and Bolts System	Wrightmedicaltechnologyinc	HWC	Class II	2014-05-15
K140571	Nxstage Pureflow Sl	NxStage Medical Inc	FKR	Class II	2014-05-15
K140329	Renegade Hi-Flo Microcatheter, Microcatheter Kit, Fathom System, Fathom Kit	Boston Scientific Corporation	KRA	Class II	2014-05-15
K140235	Xgeo Gr40cw	Samsung Electronics Co., Ltd.	MQB	Class II	2014-05-15
K140187	Ray Station	RaySearch Laboratories AB (publ)	MUJ	Class II	2014-05-15
K140133	Infuset Flow Control Extension Set	Emed Technologies Corporation	FPA	Class II	2014-05-15
K134001	Firefly	Firstkind Ltd	NGX	Class II	2014-05-15
K133763	Sonotip Pro and Pro Flex Ebus-Tbna Needle System	Medi-Globe GmbH	FCG	Class II	2014-05-15
K133752	Sonendo Omniclean Endotherpay System Console, Sonendo Omniclean Molar Procedure Kit	Sonendo Inc	ELC	Class II	2014-05-15
K133664	Encore Version 16 Software for Ge Lunar Dxa Bone Densitometers	GE Medical Systems Ultrasound & Primary Care Diagn	KGI	Class II	2014-05-15
K133662	Smith & Nephew Cannulated Captured Screw	Smith & Nephew, Inc.	HWC	Class II	2014-05-15
K133304	Rxg Distraction System	KLS-Martin L.P.	JEY	Class II	2014-05-15
K132225	Extricare	Devon Medical, Inc.	OMP	Class II	2014-05-15
K131941	Fetal Monitors	Guangdong Biolight Meditech Co., Ltd	HGM	Class II	2014-05-15
K130915	Xl-200 Clinical Chemistry Analyzer, Jas Glucose Reagent, Ise Reagent Pack	JAS Diagnostics/Drew Scientific	JJE	Class I	2014-05-15
K141010	M9 Diagnostic Ultrasound System, M9t Diagnostic Ultrasound System, M9cv Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2014-05-14
K140724	Msp Metatarsal Shortening System	Medartis AG	HRS	Class II	2014-05-14
K140604	Multifix S Knotless Fixation System	ArthroCare Corporation	MBI	Class II	2014-05-14
K140591	Bd Phaseal Closed System Transfer Device - Injector	Becton Dickinson & Co	ONB	Class II	2014-05-14
K140408	Salvation Osteopenic Screw	Wrightmedicaltechnologyinc	HWC	Class II	2014-05-14
K140255	Stop U (Packed Black USA); Stop U (Packed White USA)	Pollogen Ltd	GEI	Class II	2014-05-14
K133912	Origio Sequential Fert, Origio Sequential Fert with Phenol Red, Origio Sequential Cleav, Origio Sequential Cleav, Origio	CooperSurgical, Inc.	MQL	Class II	2014-05-14
K133700	Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic Delivery System and Pushers	Boston Scientific Corporation	FGE	Class II	2014-05-14
K133620	Cone Beam 3D and 2D Panoramic Dental Imaging System	Dental Imaging Technologies Corporation	OAS	Class II	2014-05-14
K133153	Spinefrontier Pedfuse Pedicle Screw System	SPINEFRONTIER, Inc. dba LESspine Innovations	MNH	Class II	2014-05-14
K133046	Omnipore Customized Surgical Implants	Matrix Surgical Holdings, LLC/Matrix Surgical USA	KKY	Class II	2014-05-14
K132653	Neoplate Spine Anterior Fixation System	Neoortho Productos Orthopedicos S/A	KWQ	Class II	2014-05-14
K131069	Quickscreen Amphetine 500 Test	Phamatech Inc.	DKZ	Class II	2014-05-14
K140970	One-Piece Peek Fusion Implant	Mtp Solutions, LLC	HWC	Class II	2014-05-13
K140622	Dvr Dorsal Plate, Dvr Lateral Plate, Dvr Ulna Plate	Zimmer GmbH	HRS	Class II	2014-05-13
K140568	Carefine Pen Needle with Quintapoint and Superpoint	Facet Technologies, LLC.	FMI	Class II	2014-05-13
K140395	Vitrea Image Denoising Software	Canon Medical Informatics, Inc.	LLZ	Class II	2014-05-13
K140343	Aesculap Histoacryl, Histoacryl Blue and Histoacryl Flexible Topical Skin, Adhesive with Applicator Tip	Aesculap Inc	MPN	Class II	2014-05-13
K140198	Imdx Hsv-1/2 for Abbott M2000	Intelligent Medical Devices, Inc.	OQO	Class II	2014-05-13
K140060	Digital Dental Intra Oral Sensor, Hdi 2000, Hdi 2000A	Rayence Co., Ltd.	MQB	Class II	2014-05-13
K140056	Digital Dental Intra Oral Sensor; Hdi 1000, Hdi 1000A	Rayence Co., Ltd.	MQB	Class II	2014-05-13
K133317	Penumbra System / Penumbra System Max	Penumbra Inc.	NRY	Class II	2014-05-13
K133272	Versacut + Tissue Morcellator	Lumenis Ltd	GCJ	Class II	2014-05-13
K133206	Z-Ray Intra-Oral Digital Radiography System	Zuma Dental, LLC	MUH	Class II	2014-05-13
K133148	Biomarc Coaxial Needle	Carbon Medical Technologies, Inc.	FBK	Class II	2014-05-13
K132899	Equashield Closed System Drug Transfer Device (Cstd)	Equashield Medical Ltd	ONB	Class II	2014-05-13
K130080	Easyra Ck-Mb Reagent, Easyra Crp Reagent, Easy Cal Crp Calibrator Kit, Easyqc Crp Quality Control Material	Medica Corp.	JHY	Class II	2014-05-13
DEN140004	Quidel Molecular Direct Hsv 1 +2/Vzv Assay	Ortho-Clinical Diagnostics, Inc.	PGI	Class II	2014-05-13