Cleared Traditional

IPI HUMIDIFIER CHAMBER (K993282) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K993282 · I.P.I. Medical Products · Anesthesiology device
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Sep 2000
Decision
354d
Days
Class 2
Risk

K993282 is an FDA 510(k) clearance for the IPI HUMIDIFIER CHAMBER. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by I.P.I. Medical Products (Chicago, US). The FDA issued a Cleared decision on September 18, 2000 after a review of 354 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K993282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1999
Decision Date September 18, 2000
Days to Decision 354 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
214d slower than avg
Panel avg: 140d · This submission: 354d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 55
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K993282.
H2 HEATED HUMIDIFIER
K030090 · Respironics, Inc. · Jan 2003
RESPIRONICS HEATED HUMIDIFIER
K012633 · Respironics, Inc. · Feb 2002
INVACARE PASSOVER HUMIDIFIER MODEL ISP9700
K003561 · Invacare Corp. · Apr 2001
OASIS HUMIDIFIER
K964653 · Respironics, Inc. · Feb 1997
HUMIDIFIER
K945782 · Respironics, Inc. · Mar 1996
PURITAN-BENNETT CASCADE I SERIES HUMIDIFIER MODIFICATION
K936000 · Puritan Bennett Corp. · Aug 1994