510(k) Report

510(k) · Cleared

Cleared

Schiff Reagent Fuchsin-Sulfurous Acid

K842919510(k) TraditionalCleared Sep 11, 198448-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

E K Ind., Inc. · HZT Reagent, Schiff

Cleared on Sep 11, 1984 after a 48-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Sep 11, 1984
Review
48 days
Class
Class I
Product code
HZT
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K842919Source: 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 HZT? 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?

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 HZT devices

HZT Reagent, Schiff: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HZT

FDA has decided no HZT device since 2007.

Median 510(k) review, days · HZT

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

Recalls per year · HZT

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · HZT

No MAUDE report names HZT since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—10
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 E K Ind., Inc.

50 FDA decisions under this applicant name. See the company

  • K842931Drabkin ReagentE K Ind., Inc. · 1984
  • K842938Acetic Acid 1% V/VE K Ind., Inc. · 1984
  • K842936Acetic Acid, 3% V/VE K Ind., Inc. · 1984
  • K842937Acetic Acid 2% V/VE K Ind., Inc. · 1984
  • K842934Decolorizing Fluic, Acid-Alcohol 3%E K Ind., Inc. · 1984

Recent decisions in HZT

The HZT category page

  • K883217Schiff ReagentSurgipath Medical Industries, Inc. · 1988
  • K843752Sigma Periodic Acid-Schiff Stain 395Sigma Chemical Co. · 1984
  • K842917Schiff Reagent, Pas StainE K Ind., Inc. · 1984
  • K760031Histochemical Pas Reaction SetHarleco · 1976

https://510kreport.com/device/K842919 · printed Nov 4, 2026

Cite this page

510(k) Report. “K842919: Schiff Reagent Fuchsin-Sulfurous Acid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K842919

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