Cleared Abbreviated

HAMILTON-MR1 (K122438) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K122438 · Hamilton Medical AG · Anesthesiology device
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Nov 2013
Decision
467d
Days
Class 2
Risk

K122438 is an FDA 510(k) clearance for the HAMILTON-MR1. 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 20, 2013 after a review of 467 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. 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 Hamilton Medical AG devices

Submission Details

510(k) Number K122438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2012
Decision Date November 20, 2013
Days to Decision 467 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
327d slower than avg
Panel avg: 140d · This submission: 467d
Pathway characteristics
Standards-based clearance path.

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 112
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K122438.
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PERFORMAX PEDIATRIC SE TOTAL FACE MASK
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K111610 · Respironics, Inc. · Oct 2011
ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK
K101129 · Respironics, Inc. · Sep 2010