Cleared Traditional

K163283 - HAMILTON-H900

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

K163283 · Hamilton Medical AG · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

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
163d slower than avg
Panel avg: 140d · 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 82
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K163283.
AirSpiral Heated Breathing Tube
K162553 · Fisher & Paykel Healthcare · Dec 2018
TNI softFlow 50
K180474 · Tni Medical AG · Oct 2018
Salter Labs Bubble Humidifier
K161719 · Salter Labs · 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