Cleared Traditional

K131912 - CONCHATHERM NEPTUNE HEATED HUMIDIFIER

K131912 is an FDA 510(k) clearance for CONCHATHERM NEPTUNE HEATED HUMIDIFIER, manufactured by Teleflex, Inc.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K131912 · Teleflex, Inc. · Anesthesiology device
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Mar 2014
Decision
253d
Days
Class 2
Risk

K131912 is an FDA 510(k) clearance for the CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CON.... 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 March 6, 2014 after a review of 253 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

FDA 510(k) Submission Details - K131912

510(k) Number K131912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2013
Decision Date March 06, 2014
Days to Decision 253 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
113d slower than avg
Panel avg: 140d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

All 124
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K131912.
MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit
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MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E ADULT DUAL LIMB CIRCUIT
K131957 · Fisher &Paykel Healthcare , Ltd. · Dec 2013
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AIRVO HUMIDIFIER MYAIRO HUMIDIFIER
K121975 · Fisher &Paykel Healthcare , Ltd. · Jan 2013