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 751 of 3530

510(k) clearances, page 751 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K140908	Juggerknot Mini Soft Anchor	Biomet Sports Medicine	DZL	Class II	2014-10-02
K140530	Electro Auricular Device	Navigant Consulting, Inc.	BWK	Unclassified	2014-10-02
K142460	EXPEDIUM Spine System/Synapse System	Johnson & Johnson	KWP	Class II	2014-10-01
K142450	DIVERGENCE Anterior Cervical Fusion System	Medtronic Sofamor Danek USA Inc	ODP	Class II	2014-10-01
K142364	Barrx RFA Self Sizing Balloon Catheter	Medtronic, Inc.	GEI	Class II	2014-10-01
K140577	Innesis Peek Tl Cage	BK Meditech Co., Ltd.	MAX	Class II	2014-10-01
K142258	PolyCatch Retrieval Device	Medi-Globe GmbH	FDI	Class II	2014-09-30
K142113	Esophyx2 Hd	Endogastric Solutions, Inc.	ODE	Class II	2014-09-30
K142076	Claveguard Freedom Surgical Light	Dickson & Dickson Healthcare (Us), Inc.	FSY	Class II	2014-09-30
K141598	Fuse Colonoscopy System	Boston Scientific Corporation	FDF	Class II	2014-09-30
K141547	Wingman Extendable Tip Support Catheter	ReFlow Medical, Inc	DQY	Class II	2014-09-30
K141476	Wavelight Fs200 Laser System	Alcon Laboratories	OOE	Class II	2014-09-30
K141422	Profluoro Fluoride Varnish	Pac-Dent International, Inc.	LBH	Class II	2014-09-30
K141286	Aer-O-Scope Colonoscope System	GI View Inc.	FDF	Class II	2014-09-30
K141140	Comp a-I-R	Omron Healthcare Co., Ltd.	CAF	Class II	2014-09-30
K140371	Freestyle Precision Neo Blood Glucose: Monitoring System, Test Strips (50Ct), Test Strips (100Ct)	Abbott Medical	NBW	Class II	2014-09-30
K130450	Surgtex Powdered Surgical Glove, Surgtex Powderfree Polymer Coated Surgical Glove	Purna Bina Sdn Bhd	KGO	Class I	2014-09-30
K142386	Operating Room Light Handle Adapter	Litex Manufacturing, Inc.	FTA	Class II	2014-09-29
K142054	Imacor Zura Evo Imaging System	IMACOR, Inc	IYO	Class II	2014-09-29
K141633	Pro-Picc with Valve Technology	Medical Components, Inc.	LJS	Class II	2014-09-29
K141314	Scarlet Ac-T Secured Anterior Cervical Cage and Associated Instrumentation	Spineart SA	OVE	Class II	2014-09-29
K141290	Helical Ridge Peek Interference Screw	Medshape, Inc.	HWC	Class II	2014-09-29
K142418	I.T.S. Hand Locking Plates System - HLS	I.T.S. GmbH	HRS	Class II	2014-09-26
K142339	HEMASORB Resorbable Hemostatic Bone Putty	Orthocon, Inc.	MTJ	Unclassified	2014-09-26
K142085	Discovery Mr750 3.0T ,Discovery Mr450 1.5T, Discovery Mr750 3.0T,optima Mr450w 1.5T	GE Healthcare	LNH	Class II	2014-09-26
K141935	Stryker S2 Drill	Stryker Corp.	ERL	Class II	2014-09-26
K141905	Pro-Link Wedge System	Life Spine	HRS	Class II	2014-09-26
K141800	Perfraction	Sun Nuclear Corporation	IYE	Class II	2014-09-26
K141490	Universal Segmented Cylinder Applicator Set and Universal Stump Applicator Set	Varian Medical Systems, Inc.	JAQ	Class II	2014-09-26
K141380	Provox Freehands Flexivoice	Atos Medical AB	EWL	Class II	2014-09-26
K141271	Aerodr System 2	Konica Minolta, Inc.	MQB	Class II	2014-09-26
K141113	Spacelbs Model on Trak (90227) Ambulatory Bloody Pressure (Abp) Non-Invasive	GE Healthcare	DXN	Class II	2014-09-26
K141097	Csc Series Intraluminal Stapler for Single Use	Touchstone International Medical Science Co., Ltd.	GDW	Class II	2014-09-26
K141075	Single-Site Wristed Needle Driver	Intuitive Surgical, Inc.	NAY	Class II	2014-09-26
K140380	Opera Swing	General Medical Merate S.p.A.	JAA	Class II	2014-09-26
K140369	Medline Neuro Sponge	MEDLINE INDUSTRIES, LP - Northfield	HBA	Class II	2014-09-26
K133577	Clydesdale(r) Spinal System	Medtronic Sofamor Danek USA Inc	MAX	Class II	2014-09-26
K131817	Extracorporeal Shock Wave Lithotripter	Osmunda Medical Device Consulting Co., Ltd.	LNS	Class II	2014-09-26
K142546	TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath	Spectranetics Corp.	DRE	Class II	2014-09-25
K142408	FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)	Polymed Therapeutics, Inc.	LDJ	Class II	2014-09-25
K142383	Optima XR200amx, Optima XR220amx	GE Healthcare	IZL	Class II	2014-09-25
K142000	Esoflip Es	Crospon, Ltd.	PIE	Class II	2014-09-25
K141897	Synapse System, Synthes Oc Fusion System	Synthes (USA) Products LLC	KWP	Class II	2014-09-25
K141804	Polaris Spinal System - Ha Coated	Highridge Medical, LLC	NKB	Class II	2014-09-25
K141358	Cellvizio 100 Series with System Confocal Miniprobes	Mauna Kea Technologies	OWN	Class II	2014-09-25
K141150	Pta Balloon Dilatation Catheter	Boston Scientific Corporation	LIT	Class II	2014-09-25
K141007	Demesteel (Stainless Steel) Non-Absorbable Suture	Demetech Corp.	GAQ	Class II	2014-09-25
K140670	Ellipse I2pl+/ellipse Multiflex+	Ellipse A/S	ONF	Class II	2014-09-25
K140378	Flexguide Ultra Beampath Robotic Fiber Conduit	Omni-Guide Holdings, Inc.	GEX	Class II	2014-09-25
K140088	Phantom Xl Insulated Dilators	Tedan Surgical Innovations, Inc.	PDQ	Class II	2014-09-25