Cleared Traditional

K911328 - UNIVERSAL VOLUME VENTILATOR CIRCUIT

K911328 is an FDA 510(k) clearance for UNIVERSAL VOLUME VENTILATOR CIRCUIT, manufactured by Intertech Resources, Inc.. The device is a Class 1 Anesthesiology device with product code BZO cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K911328 · Intertech Resources, Inc. · Anesthesiology device
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Aug 1991
Decision
142d
Days
Class 1
Risk

K911328 is an FDA 510(k) clearance for the UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION. Classified as Set, Tubing And Support, Ventilator (w Harness) (product code BZO), Class I - General Controls.

Submitted by Intertech Resources, Inc. (Fort Myers, US). The FDA issued a Cleared decision on August 15, 1991 after a review of 142 days - within the typical 510(k) review window.

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: 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 Intertech Resources, Inc. devices

FDA 510(k) Submission Details - K911328

510(k) Number K911328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1991
Decision Date August 15, 1991
Days to Decision 142 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
2d slower than avg
Panel avg: 140d · This submission: 142d
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 26
Devices cleared under the same product code (BZO) and FDA review panel - the closest regulatory comparables to K911328.
DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED
K922479 · Intertech Resources, Inc. · Oct 1992
GAS SAMPLING KIT MODIFICATION
K921510 · Respiratory Support Products, Inc. · Jun 1992
OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING
K890011 · Life Design Systems, Inc. · Mar 1989
BAXTER, PHARMASEAL PATIENT GAS SAMPLING LINES
K880637 · Baxter Healthcare Corp · Apr 1988
PORTABLE VENTILATOR PATIENT CIRCUIT
K873900 · Puritan Bennett Corp. · Oct 1987
END TIDAL CO2 SAMPLING CIRCUIT
K860659 · Life Design Systems, Inc. · Apr 1986