Cleared Traditional

VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)

K222822 · Draegerwerk AG & CO Kgaa · Anesthesiology

Jun 2023

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K222822 is an FDA 510(k) clearance for the VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608), a Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer (Class II — Special Controls, product code BZE), submitted by Draegerwerk AG & CO Kgaa (Luebeck, DE). The FDA issued a Cleared decision on June 14, 2023, 268 days after receiving the submission on September 19, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5270.

Submission Details

510(k) Number	K222822 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 19, 2022
Decision Date	June 14, 2023
Days to Decision	268 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