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i-STAT 09P31-25

by Abbott Point of Care Inc.

i-STAT 09P31-25 is a medical device (FDA Class II; FDA product code JGS, Electrode, Ion Specific, Sodium) made by Abbott Point of Care Inc., cleared under FDA 510(k) K053110 on 13 Jan 2006 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 10054749001917), active as of 23 Oct 2026. One FDA recall is 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

1 ongoing

Recall on shared 510(k) K053110; other models may be affected

Documents

510(k) K053110

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 Number10054749001917 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK053110 Date13 Jan 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K053110 decided 13 Jan 2006 Active
  • FDA GUDID UDI-DI 10054749001917 listed 9 Sep 2016 Listed

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-1846-2025 FDA Class II initiated 24 Apr 2025 on shared 510(k) K053110

    transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

    • Terminated Z-2022-2011 FDA Unclassified (pre-2012) initiated 15 Feb 2011

    i-STAT CHEM 8+ cartridge may generate false results for sodium, chloride and hematocrit.

    • Terminated Z-1791-2010 FDA Unclassified (pre-2012) initiated 5 Feb 2010 on shared 510(k) K053110

    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.

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

Timeline

5 dated events

  1. Cleared FDA 510(k) K053110
  2. Recall initiated FDA recalls Z-1791-2010
  3. Recall initiated FDA recalls Z-2022-2011
  4. Listed FDA GUDID 10054749001917
  5. Recall initiated FDA recalls Z-1846-2025

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  • Withdrawn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
Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
Model / Ref / Catalog
09P31-25
Primary DI / UDI-DI
10054749001917
510(k) Number
FDA product code
JGS
GMDN term
Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
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

Also classified as Creatinine/ammonium electrode IVD.

Similar devices

Other devices filed under FDA product code JGS (ELECTRODE, ION SPECIFIC, SODIUM).

Other devices from Abbott Point of Care Inc.

See all devices from Abbott Point of Care Inc. →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)