Cleared Traditional

K163283 - HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010

K163283 is an FDA 510(k) clearance for HAMILTON-H900, manufactured by Hamilton Medical AG. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 303-day FDA review.

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.

View all Hamilton Medical AG devices

FDA 510(k) Submission Details - K163283

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 140d · This submission: 303d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTT Device Classification - Class 2, Special Controls

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 153
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K163283.
AirSpiral Heated Breathing Tube
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TNI softFlow 50
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Salter Labs Bubble Humidifier
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Comfort Flo Humidification System
K162242 · Teleflexmedical, Inc. · Jan 2017
AirLife Autofill Humidification Chamber
K160764 · Carefusion 2200, Inc. · Aug 2016
FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE
K161314 · Flexicare Medical Limited. · Jul 2016