Cleared Abbreviated

GALILEO VENTILATOR (K001686) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K001686 · Hamilton Medical, Inc. · Anesthesiology device
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Jun 2000
Decision
36d
Days
Class 2
Risk

K001686 is an FDA 510(k) clearance for the GALILEO VENTILATOR. 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 June 23, 2000 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - the FDA anesthesiology and respiratory device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Hamilton Medical, Inc. devices

Submission Details

510(k) Number K001686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received May 18, 2000
Decision Date June 23, 2000
Days to Decision 36 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 140d · This submission: 36d
Pathway characteristics
Standards-based clearance path.

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 K001686.
IMAGE3 SE DISPOSABLE FULL FACE MASK
K023135 · Respironics, Inc. · Jan 2003
SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K022132 · Siemens Medical Solutions USA, Inc. · Sep 2002
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