Cleared Traditional

K833478 - HUMPHREY A.D.E. SYSTEM

K833478 is an FDA 510(k) clearance for HUMPHREY A.D.E. SYSTEM, manufactured by Anaesthetic Breathing System. The device is a Class 1 Anesthesiology device with product code CAI cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K833478 · Anaesthetic Breathing System · Anesthesiology device
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Dec 1983
Decision
53d
Days
Class 1
Risk

K833478 is an FDA 510(k) clearance for the HUMPHREY A.D.E. SYSTEM. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Anaesthetic Breathing System (Walker, US). The FDA issued a Cleared decision on December 16, 1983 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5240 - 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.

FDA 510(k) Submission Details - K833478

510(k) Number K833478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1983
Decision Date December 16, 1983
Days to Decision 53 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 140d · This submission: 53d
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 146
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K833478.
CIRCUIT BREATHING
K840740 · Marquest Medical Products, Inc. · Apr 1984
ANESTHESIA VENTILATOR CIRCUIT
K840850 · The Kendal Co. · Mar 1984
PEDIATRIC INTUBATION CIRCUIT
K840056 · Ackrad Laboratories · Feb 1984
VOLUME VENTILATOR CIRCUIT-NEBULIZER
K833196 · Airlife, Inc. · Nov 1983
SPIROMETER ISOLATION VALVE #8890
K833088 · Boehringer Mannheim Corp. · Oct 1983
SLIMB SINGLE LIMB BREATHING CIRCUIT
K832453 · Respiratory Care, Inc. · Oct 1983
K833478 · HUMPHREY A.D.E. SYSTEM
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