510(k) Report

510(k) · Cleared

Recalled · 2009

Model 100 Portable Clinical Analyzer and Test Pack

K894914510(k) TraditionalCleared Oct 16, 198975-day reviewClass II21 CFR 862.1665Recalls 6

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

I-Stat Corp. · JGS Electrode, Ion Specific, Sodium

Cleared on Oct 16, 1989 after a 75-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 6 times.

Decided
Oct 16, 1989
Review
75 days
Class
Class II
Product code
JGS
Recalls
6
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K894914Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JGS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JGS device

  1. #1 K252475 ABL90 FLEX PLUS Systemscore 12.2 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 23, 2009Not classifiedZ-1540-2009Packaging process controlEquipment problem: i-STAT cartridges were not properly sealed as the packaging system jammed, causing compromised seals.
Oct 18, 2007Not classifiedZ-0371-2008Packaging change controlDifficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.
Oct 18, 2007Not classifiedZ-0372-2008Packaging change controlDifficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.
Oct 18, 2007Not classifiedZ-0374-2008Packaging change controlDifficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.
Oct 18, 2007Not classifiedZ-0375-2008Packaging change controlDifficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.
May 24, 2006Not classifiedZ-1171-06OtherErroneous sodium and/or ionized calcium readings with a patient sample could be obtained

The 5 latest of 6 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

How does its category compare?

All JGS devices

JGS Electrode, Ion Specific, Sodium: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JGS

3in 2023

2008: 22009: 22010: 12011: 32012: 12013: 22014: 12015: 12016: 42017: 12018: 32019: 32020: 22022: 12023: 32026 (partial year): 1
2007high 4 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JGS

347in 2023

2011: 191 days median2016: 198 days median2018: 180 days median2019: 58 days median2023: 347 days median
2007high 347 (2023) · low 58 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JGS

4in 2023

2007: 72008: 12010: 12011: 12012: 22013: 52015: 12019: 52020: 12021: 12023: 4
2007high 7 (2007) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JGS

64in 2025

2007: 332008: 32009: 572010: 3612011: 9122012: 4122013: 5102014: 2512015: 1582016: 842017: 2922018: 1582019: 1052020: 892021: 912022: 602023: 982024: 962025: 64
2007high 912 (2011) · low 3 (2008)2025

MAUDE reports naming product code JGS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—733
20082—13
20092—057
20101—1361
201131911912
20121—2412
20132—5510
20141—0251
20151—1158
20164198084
20171—0292
201831800158
20193585105
20202—189
20210—191
20221—060
20233347498
20240—096
20250—064
20261—0—

More from I-Stat Corp.

14 FDA decisions under this applicant name. See the company

  • K012478Modification to: I-Stat Portable Clinical AnalyzerI-Stat Corp. · 2001
  • K011478I-Stat SystemI-Stat Corp. · 2001
  • K001387I-Stat Portable Clinical Analyzer, Model 300I-Stat Corp. · 200013 recalls
  • K001154I-Stat Model 200 Portable Clinical AnalyzerI-Stat Corp. · 20004 recalls
  • K992571I-Stat SystemI-Stat Corp. · 20004 recalls

Recent decisions in JGS

The JGS category page

  • K252475ABL90 FLEX PLUS SystemRadiometer Medicals Aps · 2026
  • K230275i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023
  • K222438A-LYTE® Integrated Multisensor (IMT Na K Cl)Siemens Healthcare Diagnostics, Inc. · 2023
  • K220977ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · 20237 recalls
  • K213486GLP systems TrackAbbott Laboratories · 2022

https://510kreport.com/device/K894914 · printed Nov 5, 2026

Cite this page

510(k) Report. “K894914: Model 100 Portable Clinical Analyzer and Test Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K894914

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026