Skip to content

Aquapak 020 Humidifier Adapter

by Respiratory Care, Inc.

510(k) K833974

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

30 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 · Traditional NumberK833974 Date16 Dec 1983ClearedStatusActive

Recalls

30 recalls · FDA

  • 15 recalls, same reason

    • Terminated Z-1103-2015 FDA Class II initiated 14 Jan 2015
    • Terminated Z-1101-2015 FDA Class II initiated 14 Jan 2015
    • Terminated Z-1104-2015 FDA Class II initiated 14 Jan 2015
    • Terminated Z-1102-2015 FDA Class II initiated 14 Jan 2015
    • Terminated Z-1096-2015 FDA Class II initiated 14 Jan 2015
    • Terminated Z-1107-2015 FDA Class II initiated 14 Jan 2015
    • Terminated Z-1098-2015 FDA Class II initiated 14 Jan 2015
    • Terminated Z-1095-2015 FDA Class II initiated 14 Jan 2015
    • Terminated Z-1105-2015 FDA Class II initiated 14 Jan 2015
    • Terminated Z-1097-2015 FDA Class II initiated 14 Jan 2015
    • Terminated Z-1108-2015 FDA Class II initiated 14 Jan 2015
    • Terminated Z-1109-2015 FDA Class II initiated 14 Jan 2015
    • Terminated Z-1106-2015 FDA Class II initiated 14 Jan 2015
    • Terminated Z-1100-2015 FDA Class II initiated 14 Jan 2015
    • Terminated Z-1099-2015 FDA Class II initiated 14 Jan 2015

    The packages may contain foreign material (black particles).

  • 14 recalls, same reason

    • Terminated Z-2005-2014 FDA Class II initiated 5 Jun 2014
    • Terminated Z-2006-2014 FDA Class II initiated 5 Jun 2014
    • Terminated Z-2014-2014 FDA Class II initiated 5 Jun 2014
    • Terminated Z-2016-2014 FDA Class II initiated 5 Jun 2014
    • Terminated Z-2004-2014 FDA Class II initiated 5 Jun 2014
    • Terminated Z-2010-2014 FDA Class II initiated 5 Jun 2014
    • Terminated Z-2011-2014 FDA Class II initiated 5 Jun 2014
    • Terminated Z-2012-2014 FDA Class II initiated 5 Jun 2014
    • Terminated Z-2013-2014 FDA Class II initiated 5 Jun 2014
    • Terminated Z-2007-2014 FDA Class II initiated 5 Jun 2014
    • Terminated Z-2017-2014 FDA Class II initiated 5 Jun 2014
    • Terminated Z-2015-2014 FDA Class II initiated 5 Jun 2014
    • Terminated Z-2009-2014 FDA Class II initiated 5 Jun 2014
    • Terminated Z-2008-2014 FDA Class II initiated 5 Jun 2014

    The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

    • Terminated Z-2003-2014 FDA Class II initiated 5 Jun 2014

    The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentially affect packaging integrity.

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
BTT
Device Class
Class II
Regulation
21 CFR Part 868.5450
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Other devices from Respiratory Care, Inc.

See all devices from Respiratory Care, Inc. →