Cleared Traditional

K971260 - SULLIVAN HUMIDAIRE HEATED HUMIDIFIER

K971260 is an FDA 510(k) clearance for SULLIVAN HUMIDAIRE HEATED HUMIDIFIER, manufactured by ResMed Corp. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K971260 · ResMed Corp · Anesthesiology device
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Sep 1997
Decision
153d
Days
Class 2
Risk

K971260 is an FDA 510(k) clearance for the SULLIVAN HUMIDAIRE HEATED HUMIDIFIER. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by ResMed Corp (San Diego, US). The FDA issued a Cleared decision on September 4, 1997 after a review of 153 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 ResMed Corp devices

FDA 510(k) Submission Details - K971260

510(k) Number K971260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1997
Decision Date September 04, 1997
Days to Decision 153 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 140d · This submission: 153d
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 110
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K971260.
CLOUD 1 HUMIDIFICATION SYSTEM
K983862 · Respiratory Support Products, Inc. · May 1999
AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006
K991484 · Allegiance Healthcare Corp. · May 1999
RESPIRATORY HUMIDIFIER, MODEL # MR850
K983112 · Fisher &Paykel Healthcare , Ltd. · Nov 1998
SCT 3000 HEATED HUMIDIFIER
K970478 · Marquest Medical Products, Inc. · Jul 1997
OASIS HUMIDIFIER
K964653 · Respironics, Inc. · Feb 1997
WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER
K962223 · Marquest Medical Products, Inc. · Jan 1997