Cleared Traditional

K012633 - RESPIRONICS HEATED HUMIDIFIER

K012633 is an FDA 510(k) clearance for RESPIRONICS HEATED HUMIDIFIER, manufactured by Respironics, Inc.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K012633 · Respironics, Inc. · Anesthesiology device
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Feb 2002
Decision
199d
Days
Class 2
Risk

K012633 is an FDA 510(k) clearance for the RESPIRONICS HEATED HUMIDIFIER. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on February 28, 2002 after a review of 199 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 Respironics, Inc. devices

FDA 510(k) Submission Details - K012633

510(k) Number K012633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2001
Decision Date February 28, 2002
Days to Decision 199 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
59d slower than avg
Panel avg: 140d · This submission: 199d
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 109
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K012633.
INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000
K031176 · Invacare Corp. · Mar 2004
RESPIRATORY HUMIDIFIER, MODEL MR850
K020332 · Fisher &Paykel Healthcare , Ltd. · Jul 2003
H2 HEATED HUMIDIFIER
K030090 · Respironics, Inc. · Jan 2003
RESPIRATORY HUMIDIFIER, MODEL HC150
K003973 · Fisher &Paykel Healthcare , Ltd. · Jun 2001
INVACARE PASSOVER HUMIDIFIER MODEL ISP9700
K003561 · Invacare Corp. · Apr 2001
BREAS HA50 HUMIDIFIER, MODEL HA50
K002454 · Vital Signs, Inc. · Mar 2001