510(k) Report

510(k) · Cleared

Cleared

Quantimetrix C-Clear (TM)

K931523510(k) TraditionalCleared Jun 25, 199391-day reviewClass I21 CFR 862.1095

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

Quantimetrix Corp. · JMA Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)

Cleared on Jun 25, 1993 after a 91-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jun 25, 1993
Review
91 days
Class
Class I
Product code
JMA
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K931523Source: 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 JMA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • 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?

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 JMA devices

JMA Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JMA

FDA has decided no JMA device since 2007.

Median 510(k) review, days · JMA

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

Recalls per year · JMA

No recall names JMA since 2007.

Adverse event reports per year · JMA

No MAUDE report names JMA 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 Quantimetrix Corp.

38 FDA decisions under this applicant name. See the company

  • K142262Aution Check PlusQuantimetrix Corp. · 2015
  • K113177Complete D 25-OH Vitamin D ControlQuantimetrix Corp. · 2012
  • K103744Dropper A1C Diabetes ControlQuantimetrix Corp. · 2011
  • K062942Quantimetrix Nicosure Cotinine Urine ControlQuantimetrix Corp. · 2006
  • K062751Modification to Quantimetrix Cardiasure Cardiac MarkerQuantimetrix Corp. · 2006

Recent decisions in JMA

The JMA category page

  • K830978Helena Biostrip aHelena Laboratories · 1983
  • K822709Uritest 9, Inlab Reagent Strips UrinalyLaprol Scientific, Inc. · 1983

https://510kreport.com/device/K931523 · printed Nov 4, 2026

Cite this page

510(k) Report. “K931523: Quantimetrix C-Clear (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K931523

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