510(k) Report

510(k) · Cleared

Cleared

Fetal Check

K792546510(k) TraditionalCleared Dec 18, 19798-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

Alta Diagnostics, Inc. · KJR Erythrosin B

Cleared on Dec 18, 1979 after an 8-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 18, 1979
Review
8 days
Class
Class I
Product code
KJR
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K792546Source: 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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  • 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 KJR devices

KJR Erythrosin B: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KJR

FDA has decided no KJR device since 2007.

Median 510(k) review, days · KJR

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

Recalls per year · KJR

No recall names KJR since 2007.

Adverse event reports per year · KJR

No MAUDE report names KJR 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 Alta Diagnostics, Inc.

5 FDA decisions under this applicant name. See the company

  • K800327Magnesium ReagentAlta Diagnostics, Inc. · 1980
  • K792545Uric Acid KitAlta Diagnostics, Inc. · 1980
  • K790796Lipase Reagent SetAlta Diagnostics, Inc. · 1979
  • K790797Amylase Reagent SetAlta Diagnostics, Inc. · 1979

Recent decisions in KJR

The KJR category page

  • K842833PMK Primary Monkey Kidney-CellsBartels Immunodiagnostic Supplies, Inc. · 1984
  • K842834Hep-2 CellsBartels Immunodiagnostic Supplies, Inc. · 1984

https://510kreport.com/device/K792546 · printed Nov 4, 2026

Cite this page

510(k) Report. “K792546: Fetal Check.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K792546

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