Cleared Traditional

K180295 - Hamilton-G5

K180295 is the FDA 510(k) clearance for Hamilton-G5 by Hamiton Medical AG. It is a Class 2 Anesthesiology device (product code CBK) cleared through the Traditional 510(k) pathway after a 544-day FDA review.

K180295 · Hamiton Medical AG · Anesthesiology device
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Jul 2019
Decision
544d
Days
Class 2
Risk

K180295 is an FDA 510(k) clearance for the Hamilton-G5. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Hamiton Medical AG (Bonaduz, CH). The FDA issued a Cleared decision on July 30, 2019 after a review of 544 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Hamiton Medical AG devices

Submission Details

510(k) Number K180295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2018
Decision Date July 30, 2019
Days to Decision 544 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
404d slower than avg
Panel avg: 140d · This submission: 544d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 196
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K180295.
Nihon Kohden NKV-550 Series Ventilator System
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