Cleared Traditional

K950582 - SULLIVAN PASSOVER HUMIDIFER

K950582 is an FDA 510(k) clearance for SULLIVAN PASSOVER HUMIDIFER, manufactured by Rescare, Inc.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K950582 · Rescare, Inc. · Anesthesiology device
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Sep 1995
Decision
218d
Days
Class 2
Risk

K950582 is an FDA 510(k) clearance for the SULLIVAN PASSOVER HUMIDIFER. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Rescare, Inc. (San Diego, US). The FDA issued a Cleared decision on September 15, 1995 after a review of 218 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 Rescare, Inc. devices

FDA 510(k) Submission Details - K950582

510(k) Number K950582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1995
Decision Date September 15, 1995
Days to Decision 218 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
78d slower than avg
Panel avg: 140d · This submission: 218d
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 173
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K950582.
HUMIDIFIER ADAPTER
K962079 · Automatic Liquid Packaging, Inc. · Jul 1996
HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCESSORIES)
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HUMIDIFIER
K945782 · Respironics, Inc. · Mar 1996
PURITAN-BENNETT CASCADE I SERIES HUMIDIFIER MODIFICATION
K936000 · Puritan Bennett Corp. · Aug 1994
MR290 HUMIDIFICATION CHAMBER SINGLE USE
K934140 · Fisher & Paykel Electronics , Ltd. · Jan 1994
HEATED RESPIRATORY HUMIDIFIER HC100
K915460 · Fisher & Paykel Electronics , Ltd. · Jan 1993