Cleared Traditional

K222822 - VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)

K222822 is an FDA 510(k) clearance for VentStar Helix dual heated (N) Plus (MP..., manufactured by Draegerwerk AG & CO Kgaa. The device is a Class 2 Anesthesiology device with product code BZE cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K222822 · Draegerwerk AG & CO Kgaa · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2023
Decision
268d
Days
Class 2
Risk

K222822 is an FDA 510(k) clearance for the VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus.... Classified as Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer within the BZE classification (a category for neonatal and pediatric respiratory circuit components), Class II - Special Controls.

Submitted by Draegerwerk AG & CO Kgaa (Luebeck, DE). The FDA issued a Cleared decision on June 14, 2023 after a review of 268 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5270 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. Neonatal respiratory circuit components typically face extended FDA review due to heightened safety scrutiny for pediatric patient populations - the 176-day cycle reflects this additional regulatory diligence.

View all Draegerwerk AG & CO Kgaa devices

FDA 510(k) Submission Details - K222822

510(k) Number K222822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 140d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZE Device Classification - Class 2, Special Controls

Product Code BZE Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5270
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BZE Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer

All 34
Devices cleared under the same product code (BZE) and FDA review panel - the closest regulatory comparables to K222822.
Heated Breathing Tube
K243244 · Guangdong Eda Technology Co., Ltd. · Jul 2025
Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)
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Hudson RCI Dri-Tech Breathing Circuits
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Sunset Heated CPAP Tube
K201418 · Sunset Healthcare Solutions, Inc. · Jan 2021
Neonatal ConchaSmart Breathing Circuits
K173280 · Teleflexmedical, Inc. · Aug 2018
AirLife Adult Heated Wire BiPAP/NIV Circuit
K170378 · Vyaire Medical · Sep 2017