Cleared Traditional

Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension Line

K234032 · Medline Industries, LP · Anesthesiology

Jun 2024

Decision

167d

Days

Class 2

Risk

About This 510(k) Submission

K234032 is an FDA 510(k) clearance for the Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension Line, a Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer (Class II — Special Controls, product code BZE), submitted by Medline Industries, LP (Nortfield, US). The FDA issued a Cleared decision on June 4, 2024, 167 days after receiving the submission on December 20, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5270.

Submission Details

510(k) Number	K234032 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 20, 2023
Decision Date	June 04, 2024
Days to Decision	167 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	BZE — Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.5270