Cleared Traditional

K061736 - COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA

K061736 is an FDA 510(k) clearance for COMFORT FLO HUMIDIFICATION SYSTEM AND N..., manufactured by Teleflex Medical. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K061736 · Teleflex Medical · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K061736

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
Combination Product No
PCCP Authorized No
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.

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 Consultant

Intertek Testing Services
NEIL E DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BTT Humidifier, Respiratory Gas, (direct Patient Interface)

All 179
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K061736.
VAPOTHERM MODEL# 2000I AND 2000H
K070056 · Vapotherm, Inc. · Apr 2007
PARI HYDRATE G
K070107 · Pari Innovative Manufacturers, Inc. · Feb 2007
HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004
K062664 · Apex Medical Corp. · Dec 2006
POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION
K062091 · Porous Media Corp. · Aug 2006
BREAS, MODEL HA01
K060790 · Breas Medical AB · May 2006
MEDISIZE GOLD
K052615 · Medisize BV · Dec 2005