Cleared Traditional

K040574 - GALILEO GOLD

K040574 is an FDA 510(k) clearance for GALILEO GOLD, manufactured by Hamilton Medical, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K040574 · Hamilton Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
237d
Days
Class 2
Risk

K040574 is an FDA 510(k) clearance for the GALILEO GOLD. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Hamilton Medical, Inc. (Reno, US). The FDA issued a Cleared decision on October 27, 2004 after a review of 237 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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.

FDA 510(k) Submission Details - K040574

510(k) Number K040574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2004
Decision Date October 27, 2004
Days to Decision 237 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 140d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CBK Ventilator, Continuous, Facility Use

All 435
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K040574.
GE DATEX-OHMEDA ENGSTROM CARESTATION
K050597 · Datex-Ohmeda, Inc. · Mar 2005
MODIFICATION TO: PNEUTON VENTILATOR
K043085 · Airon Corporation · Dec 2004
IVENT 201 PORTABLE VENTILATOR
K042468 · Versamed Medical Systems, Inc. · Nov 2004
GE DATEX-OHMEDA ENGSTROM CARESTATION
K041775 · Datex-Ohmeda, Inc. · Oct 2004
CLARISSA INFANT NCPAP CANNULA
K032922 · Airways Ltd., Inc. · Sep 2004
GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM
K041524 · Datex-Ohmeda, Inc. · Sep 2004