Cleared Traditional

K834570 - VOLUME VENTILATOR CIRCUIT W/WATER TRAP

K834570 is an FDA 510(k) clearance for VOLUME VENTILATOR CIRCUIT W/WATER TRAP, manufactured by Airlife, Inc.. The device is a Class 1 Anesthesiology device with product code BZO cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K834570 · Airlife, Inc. · Anesthesiology device
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Mar 1984
Decision
67d
Days
Class 1
Risk

K834570 is an FDA 510(k) clearance for the VOLUME VENTILATOR CIRCUIT W/WATER TRAP. Classified as Set, Tubing And Support, Ventilator (w Harness) (product code BZO), Class I - General Controls.

Submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 5, 1984 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5975 - 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 - K834570

510(k) Number K834570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1983
Decision Date March 05, 1984
Days to Decision 67 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
73d faster than avg
Panel avg: 140d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

BZO Device Classification - Class 1, General Controls

Product Code BZO Set, Tubing And Support, Ventilator (w Harness)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5975
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 - BZO Set, Tubing And Support, Ventilator (w Harness)

All 52
Devices cleared under the same product code (BZO) and FDA review panel - the closest regulatory comparables to K834570.
PATIENT TUBING HYTREL SIEMENS-ELEMA
K841657 · Siemens Elema AB · May 1984
MASS SPECTROMETER INTERFACE
K841722 · Dryden Corp. · May 1984
THREE PORT SENSOR MANIFOLD
K841637 · Dryden Corp. · May 1984
UNIVERSAL VOL. VENTILATOR 72 #1626
K832681 · Hudson Oxygen Therapy Sales Co. · Sep 1983
DISPOSABLE ADULT VO. VENTILATOR CIRCUIT
K823271 · Intec Medical, Inc. · Dec 1982
BE #16 - MANIFOLD
K823481 · Instrumentation Industries, Inc. · Dec 1982