510(k) Report

510(k) · Cleared

Cleared

King Sodium/Potassium Standard Modified

K931834510(k) TraditionalCleared Aug 25, 1993152-day reviewClass II21 CFR 862.1150

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

King Diagnostics, Inc. · JIS Calibrator, Primary

Cleared on Aug 25, 1993 after a 152-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Aug 25, 1993
Review
152 days
Class
Class II
Product code
JIS
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared1990200020102020
  1. This deviceK931834 King Sodium/Potassium Standard ModifiedKing Diagnostics, Inc. · 1993
  2. Descendant · cites it directly · 0 of its ownK032608 Gonotec Calibration Solution 300 Mosmol/KG for OsmometerGonotec Gesellschaft Fuer Mess-Und Regeltechnik MB · 2003

Most influential descendants

Showing 1 of 1 · See all
  • K032608Gonotec Calibration Solution 300 Mosmol/KG for OsmometerGonotec Gesellschaft Fuer Mess-Und Regeltechnik MB · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K931834King Sodium/Potassium Standard ModifiedKing Diagnostics, Inc.1993—
+1K032608Gonotec Calibration Solution 300 Mosmol/KG for OsmometerGonotec Gesellschaft Fuer Mess-Und Regeltechnik MB2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
FIG. 1 — Lineage of K931834, 1993–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K032608Gonotec Calibration Solution 300 Mosmol/KG for OsmometerGonotec Gesellschaft Fuer Mess-Und Regeltechnik MB20030

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, K032608 (Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB, 2003) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JIS devices

JIS Calibrator, Primary: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JIS

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JIS

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

Recalls per year · JIS

1in 2022

2008: 12011: 22012: 12016: 12018: 12020: 12021: 12022: 1
2007high 2 (2011) · low 0 (2007)2026

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

Adverse event reports per year · JIS

1in 2024

2010: 12011: 52012: 52013: 12015: 12016: 12017: 32018: 72019: 12020: 12022: 112024: 1
2007high 11 (2022) · low 0 (2007)2025

MAUDE reports naming product code JIS, 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—00
20080—10
20090—00
20100—01
20110—25
20121—15
20130—01
20140—00
20150—01
20160—11
20170—03
20180—17
20190—01
20200—11
20210—10
20220—111
20230—00
20240—01
20250—00
20260—0—

More from King Diagnostics, Inc.

41 FDA decisions under this applicant name. See the company

  • K933329King Diagnostics Iron and Total Iron Binding Capacity ReagentKing Diagnostics, Inc. · 1993
  • K931773HDL Precipitating Reagent (Dextran Sulfate)King Diagnostics, Inc. · 1993
  • K931326King Diagnostics CK ReagentKing Diagnostics, Inc. · 1993
  • K923129King Diagnostics Glucose (HK) ReagentKing Diagnostics, Inc. · 1992
  • K922969King Diagnostics Urea Nitrogen ReagentKing Diagnostics, Inc. · 1992

Recent decisions in JIS

The JIS category page

  • K122126Direct LDL/HDL Cholesterol CalibratorRandox Laboratories Limited · 2012
  • K061251Dimension Vista Total Iron Binding Capacity CalibratorDade Behring, Inc. · 2006
  • K060266Dimension Iron CalibratorDade Behring, Inc. · 20061 recall
  • K053104Dimension Cardiophase High Sensitivity C-Reactive Protein CalibratorDade Behring, Inc. · 2005
  • K032697Dimension Total Triiodothyronine Calibrator (RC414)Dade Behring, Inc. · 2003

https://510kreport.com/device/K931834 · printed Nov 6, 2026

Cite this page

510(k) Report. “K931834: King Sodium/Potassium Standard Modified.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931834

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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