Cleared Traditional

K945782 - HUMIDIFIER

K945782 is an FDA 510(k) clearance for 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 462-day FDA review.

K945782 · Respironics, Inc. · Anesthesiology device
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Mar 1996
Decision
462d
Days
Class 2
Risk

K945782 is an FDA 510(k) clearance for the 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 March 1, 1996 after a review of 462 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Respironics, Inc. devices

FDA 510(k) Submission Details - K945782

510(k) Number K945782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1994
Decision Date March 01, 1996
Days to Decision 462 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
322d slower than avg
Panel avg: 140d · This submission: 462d
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 K945782.
OASIS HUMIDIFIER
K964653 · Respironics, Inc. · Feb 1997
WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER
K962223 · Marquest Medical Products, Inc. · Jan 1997
SLEEPNET HUMIDIFIER,(84200 PACKAGED)
K963025 · Sleepnet Corporation · Nov 1996
PURITAN-BENNETT CASCADE I SERIES HUMIDIFIER MODIFICATION
K936000 · Puritan Bennett Corp. · Aug 1994
MARQUEST SCT 3000, HEATED HUMIDIFICATION SYSTEM
K903138 · Marquest Medical Products, Inc. · Oct 1990
PRECISION MEDICAL DISPOSABLE HUMIDIFIER
K902970 · Precision Medical, Inc. · Aug 1990