Cleared Special

K123637 - HAMILTON-C3

K123637 is an FDA 510(k) clearance for HAMILTON-C3, manufactured by Hamilton Medical AG. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Special 510(k) pathway after a 25-day FDA review.

K123637 · Hamilton Medical AG · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K123637

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 140d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 K123637.
HAMILTON-G5
K131774 · Hamilton Medical AG · Oct 2013
CRITICAL CARE VENTILATOR
K120931 · Oricare, Inc. · Jun 2013
VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1
K122560 · Pan-America Hyperbarics, Inc. · Mar 2013
EVOLUTION 3E VENTILATOR
K113743 · Event Medical, Inc. · Dec 2012
QUARK SERIES
K120146 · Cosmed Srl · Dec 2012
HAMILTON-C2
K121225 · Hamilton Medical AG · Nov 2012