510(k) Report

510(k) · Cleared

Cleared

Masson Trichrome Stain HT15

K833273510(k) TraditionalCleared Oct 31, 198340-day reviewClass I21 CFR 864.1850

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

Sigma Chemical Co. · ICN Biebrich Scarlet

Cleared on Oct 31, 1983 after a 40-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 31, 1983
Review
40 days
Class
Class I
Product code
ICN
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K833273Source: 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 ICN devices

ICN Biebrich Scarlet: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ICN

FDA has decided no ICN device since 2007.

Median 510(k) review, days · ICN

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

Recalls per year · ICN

No recall names ICN since 2007.

Adverse event reports per year · ICN

No MAUDE report names ICN 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 Sigma Chemical Co.

231 FDA decisions under this applicant name. See the company

  • K933694Sigma Glucose ReagentSigma Chemical Co. · 1994
  • K933678Sigma Calcium ReagentSigma Chemical Co. · 1994
  • K933696Sigma Electrolyte Reference ReagentSigma Chemical Co. · 1994
  • K933691Sigma CO2 Alkaline Buffer ReagentSigma Chemical Co. · 1993
  • K933679Sigma Bun ReagentSigma Chemical Co. · 1993

Recent decisions in ICN

The ICN category page

  • K822128Volu-Sol Single Differential StainVolu Sol Medical Industries · 1982

https://510kreport.com/device/K833273 · printed Nov 4, 2026

Cite this page

510(k) Report. “K833273: Masson Trichrome Stain HT15.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K833273

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