Cleared Traditional

K153046 - HAMILTON-MR1

K153046 is an FDA 510(k) clearance for HAMILTON-MR1, 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 323-day FDA review.

K153046 · Hamilton Medical AG · Anesthesiology device
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Sep 2016
Decision
323d
Days
Class 2
Risk

K153046 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 September 6, 2016 after a review of 323 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 - K153046

510(k) Number K153046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2015
Decision Date September 06, 2016
Days to Decision 323 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
183d slower than avg
Panel avg: 140d · This submission: 323d
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 K153046.
Puritan Bennett 980 Ventilator System
K162738 · Covidien · Oct 2017
731 Series Ventilators
K162832 · ZOLL Medical Corporation · Aug 2017
HAMILTON-C3
K161450 · Hamilton Medical AG · Apr 2017
Astral 100/150
K152068 · Resmed, Ltd. · May 2016
SERVO-U Ventilator System, SERVO-n Ventilator System
K151814 · Maquet Critical Care AB · Dec 2015
AirView
K151901 · Resmed, Ltd. · Nov 2015