Cleared Traditional

K893760 - CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004

K893760 is an FDA 510(k) clearance for CRITERION I.V. VENTILATOR BREATHING CIR..., manufactured by Nova-Ventrx. The device is a Class 1 Anesthesiology device with product code BZO cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K893760 · Nova-Ventrx · Anesthesiology device
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Aug 1989
Decision
83d
Days
Class 1
Risk

K893760 is an FDA 510(k) clearance for the CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004. Classified as Set, Tubing And Support, Ventilator (w Harness) (product code BZO), Class I - General Controls.

Submitted by Nova-Ventrx (Wheeling, US). The FDA issued a Cleared decision on August 10, 1989 after a review of 83 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 Nova-Ventrx devices

FDA 510(k) Submission Details - K893760

510(k) Number K893760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1989
Decision Date August 10, 1989
Days to Decision 83 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 140d · This submission: 83d
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 53
Devices cleared under the same product code (BZO) and FDA review panel - the closest regulatory comparables to K893760.
UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION
K911328 · Intertech Resources, Inc. · Aug 1991
TUBING FLEXIBLE MEDICAL GAS LOW-PRESSURE
K896439 · Ventlab Corp. · Jan 1990
SECHRIST DISPOSABLE INFANT BREATHING CIRCUIT
K895853 · Sechrist Industries, Inc. · Dec 1989
CIRCUIT BREATHING (W CONNECTOR, ADAPTER Y PIECE)
K890822 · Ventlab Corp. · May 1989
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