Cleared Traditional

K072926 - HELONTIX VENT

K072926 is an FDA 510(k) clearance for HELONTIX VENT, manufactured by Linde Gas Therapeutics. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 366-day FDA review.

K072926 · Linde Gas Therapeutics · Anesthesiology device
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Oct 2008
Decision
366d
Days
Class 2
Risk

K072926 is an FDA 510(k) clearance for the HELONTIX VENT. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Linde Gas Therapeutics (Se-181 81lidingo, SE). The FDA issued a Cleared decision on October 15, 2008 after a review of 366 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Linde Gas Therapeutics devices

FDA 510(k) Submission Details - K072926

510(k) Number K072926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2007
Decision Date October 15, 2008
Days to Decision 366 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
226d slower than avg
Panel avg: 140d · This submission: 366d
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 327
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K072926.
HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041
K083122 · Fisher &Paykel Healthcare , Ltd. · Mar 2009
NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM
K082724 · Newport Medical Instruments, Inc. · Dec 2008
UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV
K071526 · Impact Instrumentation, Inc. · Dec 2008
ENGSTROM CARESTATION, ENGSTROM PRO
K081842 · Datex-Ohmeda, Inc. · Oct 2008
MODIFICATION TO HAMILTON-G5
K081521 · Hamilton Medical AG · Sep 2008
MODIFICATION TO GALILEO GOLD
K080181 · Hamilton Medical AG · Jun 2008