Cleared Traditional

COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA (K061736) - FDA 510(k) Clearance

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

K061736 · Teleflex Medical · Anesthesiology device
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Aug 2006
Decision
59d
Days
Class 2
Risk

K061736 is an FDA 510(k) clearance for the COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Teleflex Medical (Bannockburn, US). The FDA issued a Cleared decision on August 18, 2006 after a review of 59 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Teleflex Medical devices

Submission Details

510(k) Number K061736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2006
Decision Date August 18, 2006
Days to Decision 59 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 140d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 56
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K061736.
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INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000
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H2 HEATED HUMIDIFIER
K030090 · Respironics, Inc. · Jan 2003
RESPIRONICS HEATED HUMIDIFIER
K012633 · Respironics, Inc. · Feb 2002