Cleared Traditional

K063758 - CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00R

K063758 is an FDA 510(k) clearance for CHONCHA THERM NEPTUNE HEATED HUMIFIER, 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 125-day FDA review.

K063758 · Teleflex Medical · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
125d
Days
Class 2
Risk

K063758 is an FDA 510(k) clearance for the CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER .... 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 April 23, 2007 after a review of 125 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.

FDA 510(k) Submission Details - K063758

510(k) Number K063758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2006
Decision Date April 23, 2007
Days to Decision 125 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
15d faster than avg
Panel avg: 140d · This submission: 125d
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 179
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K063758.
PARI HYDRATE V
K072982 · Pari Innovative Manufacturers, Inc. · Nov 2007
THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS
K071958 · Smiths Medical Asd, Inc. · Nov 2007
MEDISIZE GOLD HEATER AND BOOSTER
K070714 · Medisize BV · Apr 2007
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