Cleared Traditional

LungFlow Basket Catheter

K254040 · Free Flow Medical, Inc. · Anesthesiology

Mar 2026

Decision

86d

Days

Class 2

Risk

About This 510(k) Submission

K254040 is an FDA 510(k) clearance for the LungFlow Basket Catheter, a Bronchoscope Accessory (Class II — Special Controls, product code KTI), submitted by Free Flow Medical, Inc. (Fremont, US). The FDA issued a Cleared decision on March 12, 2026, 86 days after receiving the submission on December 16, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K254040 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 16, 2025
Decision Date	March 12, 2026
Days to Decision	86 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).