Cleared Traditional

K833196 - VOLUME VENTILATOR CIRCUIT-NEBULIZER

K833196 is an FDA 510(k) clearance for VOLUME VENTILATOR CIRCUIT-NEBULIZER, manufactured by Airlife, Inc.. The device is a Class 1 Anesthesiology device with product code CAI cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K833196 · Airlife, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1983
Decision
45d
Days
Class 1
Risk

K833196 is an FDA 510(k) clearance for the VOLUME VENTILATOR CIRCUIT-NEBULIZER. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 3, 1983 after a review of 45 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 Airlife, Inc. devices

FDA 510(k) Submission Details - K833196

510(k) Number K833196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1983
Decision Date November 03, 1983
Days to Decision 45 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
95d faster than avg
Panel avg: 140d · This submission: 45d
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 K833196.
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
SPIROMETER ISOLATION VALVE #8890
K833088 · Boehringer Mannheim Corp. · Oct 1983
SLIMB SINGLE LIMB BREATHING CIRCUIT
K832453 · Respiratory Care, Inc. · Oct 1983
BRAIN MODULE RJ-Z10
K830475 · Instrumentation Industries, Inc. · Jun 1983