Cleared Traditional

K940888 - SYSTEM 22 PAEDIATRIC MASK (FDA 510(k) Clearance)

Class I Anesthesiology device.

K940888 · Medic-Aid , Ltd. · Anesthesiology device
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Apr 1994
Decision
53d
Days
Class 1
Risk

K940888 is an FDA 510(k) clearance for the SYSTEM 22 PAEDIATRIC MASK. Classified as Mask, Oxygen (product code BYG), Class I - General Controls.

Submitted by Medic-Aid , Ltd. (Sussex, U.K. Po21 3pp, GB). The FDA issued a Cleared decision on April 19, 1994 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5580 - 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 Medic-Aid , Ltd. devices

Submission Details

510(k) Number K940888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1994
Decision Date April 19, 1994
Days to Decision 53 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
86d faster than avg
Panel avg: 139d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BYG Mask, Oxygen
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5580
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.