510(k) Report

510(k) · Cleared

Cleared

Potassium Qvet

K943026510(k) TraditionalCleared Dec 9, 1994165-day reviewClass II21 CFR 862.1600

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

Prisma Systems · CEJ Tetraphenyl Borate, Colorimetry, Potassium

Cleared on Dec 9, 1994 after a 165-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 9, 1994
Review
165 days
Class
Class II
Product code
CEJ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K943026Source: 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.

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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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All CEJ devices

CEJ Tetraphenyl Borate, Colorimetry, Potassium: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CEJ

FDA has decided no CEJ device since 2007.

Median 510(k) review, days · CEJ

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

Recalls per year · CEJ

No recall names CEJ since 2007.

Adverse event reports per year · CEJ

3in 2010

2007: 12010: 3
2007high 3 (2010) · low 0 (2008)2025

MAUDE reports naming product code CEJ, 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—01
20080—00
20090—00
20100—03
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 Prisma Systems

27 FDA decisions under this applicant name. See the company

  • K950177CK QvetPrisma Systems · 1995
  • K943027Cholesterol QvetPrisma Systems · 1995
  • K943042Bun QvetPrisma Systems · 1994
  • K943001Magnesium QvetPrisma Systems · 1994
  • K942964Lactate Dehydrogenase QvetPrisma Systems · 1994

Recent decisions in CEJ

The CEJ category page

  • K043267Potassium Test Kit and Electrolyte Cal 1 and 2Randox Laboratories, Ltd. · 2005
  • K904033Reflotron Potassium Test TabsBoehringer Mannheim Corp. · 1990
  • K902574Potassium Reagent SetTech-Co, Inc. · 1990
  • K883585Technicon Assist PotassiumTechnicon Instruments Corp. · 1988
  • K883586Technicon RA-100 System PotassiumTechnicon Instruments Corp. · 1988

https://510kreport.com/device/K943026 · printed Nov 5, 2026

Cite this page

510(k) Report. “K943026: Potassium Qvet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K943026

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