Cleared Traditional

K020700 - PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY (FDA 510(k) Clearance)

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

K020700 · Pegasus Research Corp. · Anesthesiology device
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Apr 2004
Decision
784d
Days
Class 2
Risk

K020700 is an FDA 510(k) clearance for the PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Pegasus Research Corp. (Santa Ana, US). The FDA issued a Cleared decision on April 26, 2004 after a review of 784 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 Pegasus Research Corp. devices

Submission Details

510(k) Number K020700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2002
Decision Date April 26, 2004
Days to Decision 784 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
645d slower than avg
Panel avg: 139d · This submission: 784d
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 220
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