Cleared Traditional

K792499 - AMBU PAEDI ANAESTHESIA SYSTEM

K792499 is an FDA 510(k) clearance for AMBU PAEDI ANAESTHESIA SYSTEM, manufactured by Narco Air-Shields. The device is a Class 1 Anesthesiology device with product code CAI cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K792499 · Narco Air-Shields · Anesthesiology device
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Dec 1979
Decision
15d
Days
Class 1
Risk

K792499 is an FDA 510(k) clearance for the AMBU PAEDI ANAESTHESIA SYSTEM. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Narco Air-Shields (Mchenry, US). The FDA issued a Cleared decision on December 19, 1979 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5240 - 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 Narco Air-Shields devices

FDA 510(k) Submission Details - K792499

510(k) Number K792499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1979
Decision Date December 19, 1979
Days to Decision 15 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
125d faster than avg
Panel avg: 140d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

CAI Device Classification - Class 1, General Controls

Product Code CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5240
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.

Regulatory Peers - CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)

All 69
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K792499.
PEDIATRIC ANESTHESIA CIRCUIT
K801111 · Vital Signs, Inc. · May 1980
ADULT ANESTHESIA BREATHING CIRCUITS . .
K800498 · Airlife, Inc. · Mar 1980
PEDIATRIC ANESTHESIA BREATHING CIRCUITS
K800499 · Airlife, Inc. · Mar 1980
MODIFIED JACKSON-REES CIRCUIT
K790214 · Vital Signs, Inc. · Mar 1979
BREATHING CIRCUIT PRODUCTS, ANESTHESIA
K781908 · Hospitak, Inc. · Nov 1978
BREATHING CIRCUIT, BAIN
K780044 · Respiratory Care, Inc. · Feb 1978