Cleared Traditional

K041524 - GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM

K041524 is an FDA 510(k) clearance for GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM, manufactured by Datex-Ohmeda, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K041524 · Datex-Ohmeda, Inc. · Anesthesiology device
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Sep 2004
Decision
104d
Days
Class 2
Risk

K041524 is an FDA 510(k) clearance for the GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Datex-Ohmeda, Inc. (Madison, US). The FDA issued a Cleared decision on September 20, 2004 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Datex-Ohmeda, Inc. devices

FDA 510(k) Submission Details - K041524

510(k) Number K041524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2004
Decision Date September 20, 2004
Days to Decision 104 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
36d faster than avg
Panel avg: 140d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - CBK Ventilator, Continuous, Facility Use

All 249
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K041524.
GE DATEX-OHMEDA CENTIVA/5 VENTILATOR
K050860 · Datex-Ohmeda, Inc. · Jun 2005
GE DATEX-OHMEDA ENGSTROM CARESTATION
K050597 · Datex-Ohmeda, Inc. · Mar 2005
GE DATEX-OHMEDA ENGSTROM CARESTATION
K041775 · Datex-Ohmeda, Inc. · Oct 2004
BIRD TBIRD VELA VENTILATOR
K032451 · Bird Products Corp. · Mar 2004
ESPRIT VENTILATOR, MODEL V1000
K034040 · Respironics, Inc. · Jan 2004
RAPHAEL
K022679 · Hamilton Medical AG · Oct 2003