Cleared Abbreviated

K120574 - HAMILTON-C1

K120574 is an FDA 510(k) clearance for HAMILTON-C1, manufactured by Hamilton Medical AG. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Abbreviated 510(k) pathway after a 93-day FDA review.

K120574 · Hamilton Medical AG · Anesthesiology device
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May 2012
Decision
93d
Days
Class 2
Risk

K120574 is an FDA 510(k) clearance for the HAMILTON-C1. 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 May 30, 2012 after a review of 93 days - within the typical 510(k) review window.

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 AG devices

FDA 510(k) Submission Details - K120574

510(k) Number K120574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2012
Decision Date May 30, 2012
Days to Decision 93 days
Submission Type Abbreviated
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
47d faster than avg
Panel avg: 140d · This submission: 93d
Pathway characteristics
Standards-based clearance path.

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 K120574.
HAMILTON-C2
K121225 · Hamilton Medical AG · Nov 2012
NEWPORT AURA VENTILATOR
K121891 · Newport Medical Instruments, Inc. · Nov 2012
PERFORMAX PEDIATRIC SE TOTAL FACE MASK
K120639 · Respironics, Inc. · Jul 2012
HAMILTON-T1
K120670 · Hamilton Medical AG · Apr 2012
UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR
K111473 · Impact Instrumentation, Inc. · Feb 2012
HAMILTON-TC1
K112006 · Hamilton Medical AG · Feb 2012