Cleared Traditional

K163283 - HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K163283 · Hamilton Medical AG · Anesthesiology device
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Sep 2017
Decision
303d
Days
Class 2
Risk

K163283 is an FDA 510(k) clearance for the HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Hamilton Medical AG (Bonaduz, CH). The FDA issued a Cleared decision on September 20, 2017 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5450 - 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.

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Submission Details

510(k) Number K163283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2016
Decision Date September 20, 2017
Days to Decision 303 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
164d slower than avg
Panel avg: 139d · This submission: 303d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTT Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5450
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 - BTT Humidifier, Respiratory Gas, (direct Patient Interface)

All 220
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