Cleared Traditional

K982910 - HAMILTON MEDICAL GALILEOVENTILATOR

K982910 is an FDA 510(k) clearance for HAMILTON MEDICAL GALILEOVENTILATOR, 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 392-day FDA review.

K982910 · Hamilton Medical, Inc. · Anesthesiology device
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Sep 1999
Decision
392d
Days
Class 2
Risk

K982910 is an FDA 510(k) clearance for the HAMILTON MEDICAL GALILEOVENTILATOR. 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 September 14, 1999 after a review of 392 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K982910

510(k) Number K982910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received August 18, 1998
Decision Date September 14, 1999
Days to Decision 392 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
252d slower than avg
Panel avg: 140d · This submission: 392d
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 327
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K982910.
E100M VENTILATOR (E100M)
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BEAR CUB 750 PSV
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ATC OPTION FOR EVITA 2 DURA AND EVITA 4
K992608 · Drager, Inc. · Aug 1999
DRAGER OXYLOG 2000
K984577 · Drager, Inc. · Jan 1999
PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION
K984535 · Puritan Bennett Corp. · Dec 1998