Cleared Traditional

K080149 - HEATER BASE

K080149 is an FDA 510(k) clearance for HEATER BASE, manufactured by Pacific Medico Co., Ltd.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 331-day FDA review.

K080149 · Pacific Medico Co., Ltd. · Anesthesiology device
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Dec 2008
Decision
331d
Days
Class 2
Risk

K080149 is an FDA 510(k) clearance for the HEATER BASE, MODEL PMH7000. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Pacific Medico Co., Ltd. (Tokyo, JP). The FDA issued a Cleared decision on December 18, 2008 after a review of 331 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.

View all Pacific Medico Co., Ltd. devices

FDA 510(k) Submission Details - K080149

510(k) Number K080149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2008
Decision Date December 18, 2008
Days to Decision 331 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
191d slower than avg
Panel avg: 140d · This submission: 331d
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 124
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K080149.
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K080797 · Resmed, Ltd. · Jul 2008
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