Cleared Traditional

K792144 - DISPOSA-HOOD

K792144 is an FDA 510(k) clearance for DISPOSA-HOOD, manufactured by Utah Medical Products, Inc.. The device is a Class 1 Anesthesiology device with product code FOG cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K792144 · Utah Medical Products, Inc. · Anesthesiology device
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Dec 1979
Decision
43d
Days
Class 1
Risk

K792144 is an FDA 510(k) clearance for the DISPOSA-HOOD. Classified as Hood, Oxygen, Infant (product code FOG), Class I - General Controls.

Submitted by Utah Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 5, 1979 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5700 - 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 Utah Medical Products, Inc. devices

FDA 510(k) Submission Details - K792144

510(k) Number K792144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1979
Decision Date December 05, 1979
Days to Decision 43 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 140d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

FOG Device Classification - Class 1, General Controls

Product Code FOG Hood, Oxygen, Infant
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5700
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.