Cleared Traditional

K201658 - Hamilton-C6

K201658 is an FDA 510(k) clearance for Hamilton-C6, 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 176-day FDA review.

K201658 · Hamilton Medical AG · Anesthesiology device
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Dec 2020
Decision
176d
Days
Class 2
Risk

K201658 is an FDA 510(k) clearance for the Hamilton-C6. 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 11, 2020 after a review of 176 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 - K201658

510(k) Number K201658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2020
Decision Date December 11, 2020
Days to Decision 176 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
36d slower than avg
Panel avg: 140d · This submission: 176d
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 366
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K201658.
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K193228 · Hamilton Medical AG · May 2020