Cleared Traditional

K100554 - RESPIRATORY HUMIDIFIER

K100554 is the FDA 510(k) clearance for RESPIRATORY HUMIDIFIER by Fisher &Paykel Healthcare , Ltd.. It is a Class 2 Anesthesiology device (product code BTT) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K100554 · Fisher &Paykel Healthcare , Ltd. · Anesthesiology device
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May 2010
Decision
91d
Days
Class 2
Risk

K100554 is an FDA 510(k) clearance for the RESPIRATORY HUMIDIFIER , HEATED DELIVERY SYSTEM, ADAPTOR, MODELS MR880, RT241.... Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Fisher &Paykel Healthcare , Ltd. (East Tamaki, Auckland, NZ). The FDA issued a Cleared decision on May 28, 2010 after a review of 91 days - within the typical 510(k) review window.

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 Fisher &Paykel Healthcare , Ltd. devices

Submission Details

510(k) Number K100554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2010
Decision Date May 28, 2010
Days to Decision 91 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
49d faster than avg
Panel avg: 140d · This submission: 91d
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 95
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K100554.
AIRVO HUMIDIFIER MYAIRO HUMIDIFIER
K121975 · Fisher &Paykel Healthcare , Ltd. · Jan 2013
RESPIRATORY HUMIDIFER
K110019 · Fisher &Paykel Healthcare , Ltd. · Mar 2012
THERA- HEAT HEATED HUMIDIFIER, MODEL RC70000, RC70072, RC70075, RC70077, RC70012
K092256 · Smiths Medical Asd, Inc. · Oct 2010
AIRVO SERIES HUMIDIFIERS
K092846 · Fisher &Paykel Healthcare , Ltd. · Jan 2010
HUMIDAIRE 2I
K080797 · Resmed, Ltd. · Jul 2008
RESPIRATORY HUMIDIFIER, MODEL MR850
K073706 · Fisher &Paykel Healthcare , Ltd. · Mar 2008