Cleared Traditional

K903083 - NEONATAL VENTILATOR CIRCUIT (FDA 510(k) Clearance)

Class I Anesthesiology device.

K903083 · Hudson Respiratory Care, Inc. · Anesthesiology device
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Dec 1990
Decision
168d
Days
Class 1
Risk

K903083 is an FDA 510(k) clearance for the NEONATAL VENTILATOR CIRCUIT. Classified as Set, Tubing And Support, Ventilator (w Harness) (product code BZO), Class I - General Controls.

Submitted by Hudson Respiratory Care, Inc. (Temecula, US). The FDA issued a Cleared decision on December 27, 1990 after a review of 168 days - an extended review 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: 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 Hudson Respiratory Care, Inc. devices

Submission Details

510(k) Number K903083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1990
Decision Date December 27, 1990
Days to Decision 168 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 139d · This submission: 168d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.