Cleared Traditional

K131388 - TRANSCEND HEATED HUMIDIFIER

K131388 is an FDA 510(k) clearance for TRANSCEND HEATED HUMIDIFIER, manufactured by Somnetics International, Inc.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K131388 · Somnetics International, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
135d
Days
Class 2
Risk

K131388 is an FDA 510(k) clearance for the TRANSCEND HEATED HUMIDIFIER. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Somnetics International, Inc. (New Brighton, US). The FDA issued a Cleared decision on September 26, 2013 after a review of 135 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 Somnetics International, Inc. devices

FDA 510(k) Submission Details - K131388

510(k) Number K131388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2013
Decision Date September 26, 2013
Days to Decision 135 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
5d faster than avg
Panel avg: 140d · This submission: 135d
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 153
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K131388.
CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN
K131912 · Teleflex, Inc. · Mar 2014
MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E ADULT DUAL LIMB CIRCUIT
K131957 · Fisher &Paykel Healthcare , Ltd. · Dec 2013
AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER
K131895 · Fisher &Paykel Healthcare , Ltd. · Oct 2013
MEDISIZE GOLD HEATER AND BOOSTER T-PIECE
K122885 · Medisize BV · Aug 2013
HUMICARE D900
K122705 · Grundler GmbH · May 2013
AIRVO HUMIDIFIER MYAIRO HUMIDIFIER
K121975 · Fisher &Paykel Healthcare , Ltd. · Jan 2013