Cleared Traditional

K121225 - HAMILTON-C2

K121225 is an FDA 510(k) clearance for HAMILTON-C2, manufactured by Hamilton Medical AG. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K121225 · Hamilton Medical AG · Anesthesiology device
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Nov 2012
Decision
207d
Days
Class 2
Risk

K121225 is an FDA 510(k) clearance for the HAMILTON-C2. 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 November 16, 2012 after a review of 207 days - an extended review cycle.

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. Standard predicate reliance. 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 AG devices

FDA 510(k) Submission Details - K121225

510(k) Number K121225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2012
Decision Date November 16, 2012
Days to Decision 207 days
Submission Type Traditional
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
67d slower than avg
Panel avg: 140d · This submission: 207d
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 319
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K121225.
HAMILTON-MR1
K122438 · Hamilton Medical AG · Nov 2013
HAMILTON-G5
K131774 · Hamilton Medical AG · Oct 2013
HAMILTON-C3
K123637 · Hamilton Medical AG · Dec 2012
NEWPORT AURA VENTILATOR
K121891 · Newport Medical Instruments, Inc. · Nov 2012
PERFORMAX PEDIATRIC SE TOTAL FACE MASK
K120639 · Respironics, Inc. · Jul 2012
HAMILTON-C1
K120574 · Hamilton Medical AG · May 2012