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i-STAT 04J48-20

by Abbott Point of Care Inc.

i-STAT 04J48-20 is a Class II device made by Abbott Point of Care Inc., cleared under FDA 510(k) K001387 on 5 Oct 2000 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00054749001262), active as of 23 Oct 2026. 6 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

13 closed

Documents

510(k) K001387

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 Number00054749001262 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK001387 Date5 Oct 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K001387 decided 5 Oct 2000 Active
  • FDA GUDID UDI-DI 00054749001262 listed 22 Sep 2016 Listed

Recalls

13 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-1974-2012 FDA Class II initiated 8 Sep 2011 on shared 510(k) K001387
    • Terminated Z-1978-2012 FDA Class II initiated 8 Sep 2011 on shared 510(k) K001387
    • Terminated Z-1973-2012 FDA Class II initiated 8 Sep 2011 on shared 510(k) K001387
    • Terminated Z-1976-2012 FDA Class II initiated 8 Sep 2011 on shared 510(k) K001387
    • Terminated Z-1975-2012 FDA Class II initiated 8 Sep 2011 on shared 510(k) K001387
    • Terminated Z-1977-2012 FDA Class II initiated 8 Sep 2011 on shared 510(k) K001387

    Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.

  • 2 recalls, same reason

    • Terminated Z-0598-2011 FDA Unclassified (pre-2012) initiated 20 Sep 2010
    • Terminated Z-0597-2011 FDA Unclassified (pre-2012) initiated 20 Sep 2010

    i-STAT Analyzers batteries may overheat due to a circuitry failure, resulting in the analyzer becoming uncomfortably hot in the area of the battery component.

    • Terminated Z-2462-2010 FDA Unclassified (pre-2012) initiated 20 Aug 2010

    Reliability issues associated with broken connection pins within the downloader that mate with the pins from the analyzer.

    • Terminated Z-1133-2010 FDA Unclassified (pre-2012) initiated 6 Nov 2009

    Some Martel Printers used with the i-STAT 1 system have the potential of being damaged due to the use or rechargeable battery packs that do not contain a fuse.

    • Terminated Z-0865-2010 FDA Unclassified (pre-2012) initiated 29 Sep 2009 on shared 510(k) K001387

    Abbott Point of Care has determined that it is possible under certain circumstances that some test records could have their status update messages mis-matched with another record, resulting in the incorrect patient name, order number of comment being included in the CDS test record only.

    • Terminated Z-0812-2010 FDA Unclassified (pre-2012) initiated 9 Sep 2009

    The storage temperature on the label on the side of the i-Stat Portable Clinical Analyzer shipping box does not match product specification.

    • Terminated Z-2328-2009 FDA Unclassified (pre-2012) initiated 22 Apr 2009

    It appears that the rechargeable battery pack is overheating with or without the presence of smoke.

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

Timeline

15 dated events

  1. Recall initiated FDA recalls Z-2462-2010
  2. Recall initiated FDA recalls Z-0598-2011
  3. Recall initiated FDA recalls Z-0597-2011
  4. Recall initiated FDA recalls Z-1974-2012
  5. Recall initiated FDA recalls Z-1978-2012
  6. Recall initiated FDA recalls Z-1973-2012
  7. Recall initiated FDA recalls Z-1976-2012
  8. Recall initiated FDA recalls Z-1975-2012
  9. Recall initiated FDA recalls Z-1977-2012
  10. Listed FDA GUDID 00054749001262

5 earlier events 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
Multiple clinical chemistry analyser IVD, point-of-care
Model / Ref / Catalog
04J48-20
Primary DI / UDI-DI
00054749001262
510(k) Number
FDA product code
CGA
GMDN term
Multiple clinical chemistry analyser IVD, point-of-care
Device class
Class II
Regulation number
862.1345
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple clinical chemistry analyser IVD, point-of-care

Cleared under the same submission (K001387)

and 8 more cleared under K001387

Similar devices

Other devices filed under FDA product code CGA (GLUCOSE OXIDASE, GLUCOSE).

Other devices from Abbott Point of Care Inc.

See all devices from Abbott Point of Care Inc. →

Properties

  • Combination product
  • Lot / batch number
  • Serial number
Other properties (12, all answered No)