Cleared Special

HAMILTON-C3 (K123637) - FDA 510(k) Clearance

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

K123637 · Hamilton Medical AG · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
25d
Days
Class 2
Risk

K123637 is an FDA 510(k) clearance for the HAMILTON-C3. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Hamilton Medical AG (Bonaduz, CH). The FDA issued a Cleared decision on December 21, 2012 after a review of 25 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Hamilton Medical AG devices

Submission Details

510(k) Number K123637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2012
Decision Date December 21, 2012
Days to Decision 25 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 140d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 112
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K123637.
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PERFORMAX PEDIATRIC SE TOTAL FACE MASK
K120639 · Respironics, Inc. · Jul 2012
TRILOGY SERIES VENTILATOR WITH OXIMETRY
K111610 · Respironics, Inc. · Oct 2011
ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK
K101129 · Respironics, Inc. · Sep 2010