Cleared Traditional

HAMILTON MEDICAL GALILEOVENTILATOR (K982910) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 110
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K982910.
PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION
K001646 · Puritan Bennett Corp. · Oct 2000
ESPIRT
K001208 · Respironics, Inc. · May 2000
PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840
K993071 · Puritan Bennett Corp. · Nov 1999
PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION
K984535 · Puritan Bennett Corp. · Dec 1998
NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM
K984379 · Puritan Bennett Corp. · Dec 1998
ESPRIT VENTILATOR
K981072 · Respironics, Inc. · Nov 1998