Cleared Traditional

LIA-1 Catheter (542-1)

K251402 · Leadoptik, Inc. · Anesthesiology

Dec 2025

Decision

227d

Days

Class 2

Risk

About This 510(k) Submission

K251402 is an FDA 510(k) clearance for the LIA-1 Catheter (542-1), a Bronchoscope Accessory (Class II — Special Controls, product code KTI), submitted by Leadoptik, Inc. (San Jose, US). The FDA issued a Cleared decision on December 19, 2025, 227 days after receiving the submission on May 6, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K251402 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 06, 2025
Decision Date	December 19, 2025
Days to Decision	227 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	KTI — Bronchoscope Accessory
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4680
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).