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EMG CTA01-Xxx Series Puro Oxygen Concentrator

by Emg Technology Co., Ltd.

510(k) K043520

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK043520 Date21 Oct 2005ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1473-2008 FDA Unclassified (pre-2012) initiated 4 Mar 2008
    • Terminated Z-1474-2008 FDA Unclassified (pre-2012) initiated 4 Mar 2008

    Overheating of Components: There is the potential for an electrical component in the oxygen concentrator to overheat, causing damage to the unit and making it nonfunctional.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CAW
Device Class
Class II
Regulation
21 CFR Part 868.5440
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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