Cleared Traditional

K840056 - PEDIATRIC INTUBATION CIRCUIT

K840056 is an FDA 510(k) clearance for PEDIATRIC INTUBATION CIRCUIT, manufactured by Ackrad Laboratories. The device is a Class 1 Anesthesiology device with product code CAI cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K840056 · Ackrad Laboratories · Anesthesiology device
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Feb 1984
Decision
35d
Days
Class 1
Risk

K840056 is an FDA 510(k) clearance for the PEDIATRIC INTUBATION CIRCUIT. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Ackrad Laboratories (Mchenry, US). The FDA issued a Cleared decision on February 10, 1984 after a review of 35 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 Ackrad Laboratories devices

FDA 510(k) Submission Details - K840056

510(k) Number K840056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1984
Decision Date February 10, 1984
Days to Decision 35 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
105d faster than avg
Panel avg: 140d · This submission: 35d
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 48
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K840056.
BABYSET TM & PAC TM -PULMONARY ASSIST
K841264 · Life Design Systems, Inc. · Jun 1984
CIRCUIT BREATHING
K840740 · Marquest Medical Products, Inc. · Apr 1984
ANESTHESIA VENTILATOR CIRCUIT
K840850 · The Kendal Co. · Mar 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