Cleared Traditional

K945740 - INFANT FLOW SYSTEM

K945740 is an FDA 510(k) clearance for INFANT FLOW SYSTEM, manufactured by Hamilton Medical, Inc.. The device is a Class 1 Anesthesiology device with product code BZO cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K945740 · Hamilton Medical, Inc. · Anesthesiology device
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Mar 1995
Decision
120d
Days
Class 1
Risk

K945740 is an FDA 510(k) clearance for the INFANT FLOW SYSTEM. Classified as Set, Tubing And Support, Ventilator (w Harness) (product code BZO), Class I - General Controls.

Submitted by Hamilton Medical, Inc. (Reno, US). The FDA issued a Cleared decision on March 23, 1995 after a review of 120 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 Hamilton Medical, Inc. devices

FDA 510(k) Submission Details - K945740

510(k) Number K945740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1994
Decision Date March 23, 1995
Days to Decision 120 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 140d · This submission: 120d
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 46
Devices cleared under the same product code (BZO) and FDA review panel - the closest regulatory comparables to K945740.
PRIMA BREATHING BAGS
K952011 · Prima, Inc. · May 1995
PRIMA CUSTOM ANESTESIA CIRCUIT
K952012 · Prima, Inc. · May 1995
PRIMA VOLUMN VENTILATORSS
K952022 · Prima, Inc. · May 1995
PRIMA, INC. CORRUGATED TUBING
K944531 · Prima, Inc. · Dec 1994
TUBE, INHALER OXYGEN
K935582 · Puritas Health Care, Inc. · Jan 1994
STAR BREATHING CIRCUITS
K934753 · Infrasonics Corp. · Oct 1993