Cleared Abbreviated

K100920 - MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES

K100920 is an FDA 510(k) clearance for MESA II OXYGEN CONCENTRATOR MODEL: T200..., manufactured by Sequal Technologies Co., Ltd.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Abbreviated 510(k) pathway after a 241-day FDA review.

K100920 · Sequal Technologies Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K100920

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
101d slower than avg
Panel avg: 140d · This submission: 241d
Pathway characteristics
Standards-based clearance path.

CAW Device Classification - Class 2, Special Controls

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 224
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K100920.
CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L
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MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD
K093308 · Nidek Medical Products, Inc. · Jan 2010