Cleared Traditional

CONCHASMART BREATHING CIRCUIT (K140556) - FDA 510(k) Clearance

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

K140556 · Teleflex, Inc. · Anesthesiology device
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Sep 2014
Decision
203d
Days
Class 2
Risk

K140556 is an FDA 510(k) clearance for the CONCHASMART BREATHING CIRCUIT. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Teleflex, Inc. (Durham, US). The FDA issued a Cleared decision on September 24, 2014 after a review of 203 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 Teleflex, Inc. devices

Submission Details

510(k) Number K140556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2014
Decision Date September 24, 2014
Days to Decision 203 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
63d slower than avg
Panel avg: 140d · This submission: 203d
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 56
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K140556.
Palladium High Flow Therapy System
K191010 · Vapotherm, Inc. · Oct 2019
AirSpiral Heated Breathing Tube
K162553 · Fisher & Paykel Healthcare · Dec 2018
TNI softFlow 50
K180474 · Tni Medical AG · Oct 2018
HUMIDAIRE 2I
K080797 · Resmed, Ltd. · Jul 2008
INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000
K031176 · Invacare Corp. · Mar 2004
H2 HEATED HUMIDIFIER
K030090 · Respironics, Inc. · Jan 2003