Cleared Traditional

K152029 - HAMILTON-H900

K152029 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 286-day FDA review.

K152029 · Hamilton Medical AG · Anesthesiology device
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May 2016
Decision
286d
Days
Class 2
Risk

K152029 is an FDA 510(k) clearance for the HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC.... 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 May 3, 2016 after a review of 286 days - an extended review cycle.

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. Standard predicate reliance. 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 - K152029

510(k) Number K152029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2015
Decision Date May 03, 2016
Days to Decision 286 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
146d slower than avg
Panel avg: 140d · This submission: 286d
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 123
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K152029.
Salter Labs Bubble Humidifier
K161719 · Salter Labs · Sep 2017
HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010
K163283 · Hamilton Medical AG · Sep 2017
Comfort Flo Humidification System
K162242 · Teleflexmedical, Inc. · Jan 2017
MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit
K143646 · Fisher &Paykel Healthcare , Ltd. · Mar 2015
HUDSON RCI AQUAPAK HUMIDIFIER ADAPTOR
K141353 · Teleflexmedical, Inc. · Aug 2014
HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT
K132017 · Fisher &Paykel Healthcare , Ltd. · Mar 2014