Cleared Abbreviated

K100920 - MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K100920 · Sequal Technologies Co., Ltd. · Anesthesiology device
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Nov 2010
Decision
241d
Days
Class 2
Risk

K100920 is an FDA 510(k) clearance for the MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES. Classified as Generator, Oxygen, Portable within the CAW classification (a category for home-use oxygen therapy and respiratory devices), Class II - Special Controls.

Submitted by Sequal Technologies Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on November 29, 2010 after a review of 241 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5440 - the FDA anesthesiology and respiratory device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Sequal Technologies Co., Ltd. devices

Submission Details

510(k) Number K100920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2010
Decision Date November 29, 2010
Days to Decision 241 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 139d · This submission: 241d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code CAW Generator, Oxygen, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5440
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 - CAW Generator, Oxygen, Portable

All 284
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