Cleared Traditional

K092148 - HAMILTON-C2

K092148 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 232-day FDA review.

K092148 · Hamilton Medical AG · Anesthesiology device
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Mar 2010
Decision
232d
Days
Class 2
Risk

K092148 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 March 4, 2010 after a review of 232 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 - K092148

510(k) Number K092148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2009
Decision Date March 04, 2010
Days to Decision 232 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 140d · This submission: 232d
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 K092148.
ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK
K101129 · Respironics, Inc. · Sep 2010
NEWPORT E360 VENTILATOR
K101803 · Newport Medical Instruments, Inc. · Sep 2010
TRILOGY 202 VENTILATOR
K093905 · Respironics, Inc. · May 2010
TRILOGY 200 VENTILATOR
K093416 · Respironics, Inc. · Jan 2010
RESPIRONICS PERFORMAX SE TOTAL FACE MASK
K092648 · Respironics Inc., Sleep & Home Respiratory Group · Dec 2009
NEWPORT HT70 FAMILY OF VENTILATORS
K090888 · Newport Medical Instruments, Inc. · Nov 2009