Cleared Traditional

K062664 - HUMIDCARE HEATED HUMIDIFIER

K062664 is an FDA 510(k) clearance for HUMIDCARE HEATED HUMIDIFIER, manufactured by Apex Medical Corp.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K062664 · Apex Medical Corp. · Anesthesiology device
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Dec 2006
Decision
90d
Days
Class 2
Risk

K062664 is an FDA 510(k) clearance for the HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Apex Medical Corp. (Tucheng City, Taipei County, TW). The FDA issued a Cleared decision on December 6, 2006 after a review of 90 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 Apex Medical Corp. devices

FDA 510(k) Submission Details - K062664

510(k) Number K062664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2006
Decision Date December 06, 2006
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 140d · This submission: 90d
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 123
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K062664.
RESPIRATORY HUMIDIFIER, MODEL MR850
K073706 · Fisher &Paykel Healthcare , Ltd. · Mar 2008
THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS
K071958 · Smiths Medical Asd, Inc. · Nov 2007
CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00R
K063758 · Teleflex Medical · Apr 2007
COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA
K061736 · Teleflex Medical · Aug 2006
REMREST HEATED HUMIDIFIER
K050990 · Medical Industries America, Inc. · May 2005
AQUINOX
K050314 · Smiths Medical Asd, Inc. · Feb 2005