Cleared Traditional

K863756 - MODIFIED CRITERION VENTILATOR BREATHING CIRCUIT

K863756 is an FDA 510(k) clearance for MODIFIED CRITERION VENTILATOR BREATHING..., 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 49-day FDA review.

K863756 · Nova-Ventrx · Anesthesiology device
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Nov 1986
Decision
49d
Days
Class 1
Risk

K863756 is an FDA 510(k) clearance for the MODIFIED CRITERION VENTILATOR BREATHING CIRCUIT. 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 November 13, 1986 after a review of 49 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 - K863756

510(k) Number K863756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1986
Decision Date November 13, 1986
Days to Decision 49 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 140d · This submission: 49d
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 K863756.
BAXTER, PHARMASEAL PATIENT GAS SAMPLING LINES
K880637 · Baxter Healthcare Corp · Apr 1988
PORTABLE VENTILATOR PATIENT CIRCUIT
K873900 · Puritan Bennett Corp. · Oct 1987
REUSEABLE BREATHING TUBES
K873927 · Dryden Corp. · Oct 1987
END TIDAL CO2 SAMPLING CIRCUIT
K860659 · Life Design Systems, Inc. · Apr 1986
GAS SAMPLING KIT
K861286 · Respiratory Support Products, Inc. · Apr 1986
DISPOSABLE VENTILATOR CIRCUITS
K860879 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986