Cleared Traditional

K951652 - VENTIMASK MK IV (FDA 510(k) Clearance)

Class I Anesthesiology device.

K951652 · Flexicare Medical, Ltd. · Anesthesiology device
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Apr 1995
Decision
17d
Days
Class 1
Risk

K951652 is an FDA 510(k) clearance for the VENTIMASK MK IV. Classified as Mask, Oxygen, Low Concentration, Venturi (product code BYF), Class I - General Controls.

Submitted by Flexicare Medical, Ltd. (Somerset, GB). The FDA issued a Cleared decision on April 27, 1995 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5600 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Flexicare Medical, Ltd. devices

Submission Details

510(k) Number K951652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1995
Decision Date April 27, 1995
Days to Decision 17 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 139d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BYF Mask, Oxygen, Low Concentration, Venturi
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5600
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.