Cleared Traditional

Ventoux VC2 (K223120) - FDA 510(k) Clearance

Also marketed or referenced as:
Ventoux VC3

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223120 · Flight Medical Innovations , Ltd. · Anesthesiology device
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Dec 2024
Decision
791d
Days
Class 2
Risk

K223120 is an FDA 510(k) clearance for the Ventoux VC2. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Flight Medical Innovations , Ltd. (Petach Tikva, IL). The FDA issued a Cleared decision on December 2, 2024 after a review of 791 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Flight Medical Innovations , Ltd. devices

Submission Details

510(k) Number K223120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2022
Decision Date December 02, 2024
Days to Decision 791 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
651d slower than avg
Panel avg: 140d · This submission: 791d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 106
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