Cleared Traditional

K832453 - SLIMB SINGLE LIMB BREATHING CIRCUIT

K832453 is an FDA 510(k) clearance for SLIMB SINGLE LIMB BREATHING CIRCUIT, manufactured by Respiratory Care, Inc.. The device is a Class 1 Anesthesiology device with product code CAI cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K832453 · Respiratory Care, Inc. · Anesthesiology device
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Oct 1983
Decision
93d
Days
Class 1
Risk

K832453 is an FDA 510(k) clearance for the SLIMB SINGLE LIMB BREATHING CIRCUIT. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Respiratory Care, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 27, 1983 after a review of 93 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Respiratory Care, Inc. devices

FDA 510(k) Submission Details - K832453

510(k) Number K832453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1983
Decision Date October 27, 1983
Days to Decision 93 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
47d faster than avg
Panel avg: 140d · This submission: 93d
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 116
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K832453.
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
BRAIN MODULE RJ-Z10
K830475 · Instrumentation Industries, Inc. · Jun 1983
ANESTHESIA BREATHING CIRCUITS
K830470 · Mon-A-Therm, Inc. · Mar 1983
DISPOSABLE NON-REBREATHING ANES. CIRCUIT
K823714 · Marquest Medical Products, Inc. · Jan 1983