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i-STAT 03P80-25

by Abbott Point of Care Inc.

i-STAT 03P80-25 is a Class II device made by Abbott Point of Care Inc., cleared under FDA 510(k) K912387 on 1 Jul 1991 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 10054749000088), active as of 23 Oct 2026. 5 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

9 closed

Documents

510(k) K912387

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10054749000088 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK912387 Date1 Jul 1991DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K912387 decided 1 Jul 1991 Active
  • FDA GUDID UDI-DI 10054749000088 listed 9 Sep 2016 Listed

Recalls

9 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-1796-2010 FDA Unclassified (pre-2012) initiated 5 Feb 2010 on shared 510(k) K912387
    • Terminated Z-1797-2010 FDA Unclassified (pre-2012) initiated 5 Feb 2010 on shared 510(k) K912387
    • Terminated Z-1798-2010 FDA Unclassified (pre-2012) initiated 5 Feb 2010 on shared 510(k) K912387

    Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.

    • Terminated Z-1540-2009 FDA Unclassified (pre-2012) initiated 23 Feb 2009 on shared 510(k) K912387

    Equipment problem: i-STAT cartridges were not properly sealed as the packaging system jammed, causing compromised seals.

  • 4 recalls, same reason

    • Terminated Z-0372-2008 FDA Unclassified (pre-2012) initiated 18 Oct 2007
    • Terminated Z-0374-2008 FDA Unclassified (pre-2012) initiated 18 Oct 2007
    • Terminated Z-0375-2008 FDA Unclassified (pre-2012) initiated 18 Oct 2007
    • Terminated Z-0371-2008 FDA Unclassified (pre-2012) initiated 18 Oct 2007

    Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.

    • Terminated Z-0370-2008 FDA Unclassified (pre-2012) initiated 18 Oct 2007

    Difficult to Close -- Certian lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

11 dated events

  1. Recall initiated FDA recalls Z-0372-2008
  2. Recall initiated FDA recalls Z-0374-2008
  3. Recall initiated FDA recalls Z-0375-2008
  4. Recall initiated FDA recalls Z-0371-2008
  5. Recall initiated FDA recalls Z-0370-2008
  6. Recall initiated FDA recalls Z-1540-2009
  7. Recall initiated FDA recalls Z-1796-2010
  8. Recall initiated FDA recalls Z-1797-2010
  9. Recall initiated FDA recalls Z-1798-2010
  10. Listed FDA GUDID 10054749000088

1 earlier event are in the sections above.

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
i-STAT
Generic name
Potassium (K+) electrode IVD
Model / Ref / Catalog
03P80-25
Primary DI / UDI-DI
10054749000088
510(k) Number
FDA product code
JGS
GMDN term
Potassium (K+) electrode IVD
Device class
Class II
Regulation number
862.1665
GUDID distribution status
In Commercial Distribution

Related devices

Category: Urea IVD, reagentMultiple blood gas/haemoximetry/electrolyte analyte IVD, reagentSodium (Na+) electrode IVDChloride (Cl-) electrode IVD

Similar devices in this category

Other devices filed under Potassium (K+) electrode IVD.

Other devices from Abbott Point of Care Inc.

See all devices from Abbott Point of Care Inc. →

Properties

  • Single use
  • Contains latex
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)