Cleared Traditional

K903083 - NEONATAL VENTILATOR CIRCUIT

K903083 is an FDA 510(k) clearance for NEONATAL VENTILATOR CIRCUIT, manufactured by Hudson Respiratory Care, Inc.. The device is a Class 1 Anesthesiology device with product code BZO cleared through the Traditional 510(k) pathway after a 168-day FDA review.

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

FDA 510(k) Submission Details - K903083

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
28d slower than avg
Panel avg: 140d · This submission: 168d
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 K903083.
DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED
K922479 · Intertech Resources, Inc. · Oct 1992
GAS SAMPLING KIT MODIFICATION
K921510 · Respiratory Support Products, Inc. · Jun 1992
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