510(k) Report

510(k) · Cleared

Cleared

I-Stat Control Levels 1,2,3

K934641510(k) TraditionalCleared Dec 9, 199379-day reviewClass I21 CFR 862.1660

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

I-Stat Corp. · JJR Electrolyte Controls (Assayed And Unassayed)

Cleared on Dec 9, 1993 after a 79-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.

Decided
Dec 9, 1993
Review
79 days
Class
Class I
Product code
JJR
Recalls
None
Predicates
0

4 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared1996: 1 descendant cleared1999: 1 descendant cleared2004: 1 descendant cleared1990200020102020
  1. This deviceK934641 I-Stat Control Levels 1,2,3I-Stat Corp. · 1993
  2. Descendant · cites it directly · 2 of its ownK961195 Chem-Chex StatStreck Laboratories, Inc. · 1996
  3. Descendant · 2 generations on · 1 of its ownK993321 R&D HGB/GLC Whole Blood ControlR&D Systems, Inc. · 1999
  4. Descendant · 3 generations on · 0 of its ownK034048 R&D Glu-Line Hematology ControlR&D Systems, Inc. · 2004
  5. Descendant · cites it directly · 0 of its ownK982290 Chem-Chex Stat (New)Streck Laboratories, Inc. · 1998

Most influential descendants

Showing 4 of 4 · See all
  • K961195Chem-Chex StatStreck Laboratories, Inc. · 1996 · cites it directly2descendants
  • K993321R&D HGB/GLC Whole Blood ControlR&D Systems, Inc. · 1999 · 2 generations on1descendant
  • K034048R&D Glu-Line Hematology ControlR&D Systems, Inc. · 2004 · 3 generations on0descendants
  • K982290Chem-Chex Stat (New)Streck Laboratories, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K934641I-Stat Control Levels 1,2,3I-Stat Corp.1993—
+1K961195Chem-Chex StatStreck Laboratories, Inc.1996—
+2K993321R&D HGB/GLC Whole Blood ControlR&D Systems, Inc.1999—
+3K034048R&D Glu-Line Hematology ControlR&D Systems, Inc.2004—
+1K982290Chem-Chex Stat (New)Streck Laboratories, Inc.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199810
199910
200410
FIG. 1 — Lineage of K934641, 1993–2004Source: FDA 510(k) summaries, read by 510(k) Report · 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 JJR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K961195Chem-Chex StatStreck Laboratories, Inc.19962
K982290Chem-Chex Stat (New)Streck Laboratories, Inc.19980

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K961195 (Streck Laboratories, Inc., 1996) has gone furthest, with 2 descendants of its own.

How does its category compare?

All JJR devices

JJR Electrolyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJR

FDA has decided no JJR device since 2007.

Median 510(k) review, days · JJR

Too few JJR 510(k)s in any year since 2007 to give a median.

Recalls per year · JJR

No recall names JJR since 2007.

Adverse event reports per year · JJR

No MAUDE report names JJR since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—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 JJR

The JJR category page

  • K990971Easylyte Quality Control Kit, Models 2814, 2815, 2816Medica Corp. · 1999
  • K960592Electrolyte StandardsPhoenix Diagnostics, Inc. · 1996
  • K955630Rna Medical Hemat ControlBionostics, Inc. · 1996
  • K951435Aalto Scientific Sweat Chloride Reference MaterialAalto Scientific, Ltd. · 1995
  • K943925Sweat Controls for Cystic Fibrosis TestingQuantimetrix Corp. · 1994

https://510kreport.com/device/K934641 · printed Nov 4, 2026

Cite this page

510(k) Report. “K934641: I-Stat Control Levels 1,2,3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K934641

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