510(k) Report

510(k) · Cleared

Cleared

Agglutinotest-Tuberculosis

K791452510(k) TraditionalCleared Sep 24, 197949-day reviewClass I21 CFR 866.3370

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

Volu Sol Medical Industries · GRT Antiserum, Fluorescent, Mycobacterium Tuberculosis

Cleared on Sep 24, 1979 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Sep 24, 1979
Review
49 days
Class
Class I
Product code
GRT
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K791452Source: 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 GRT? 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 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 GRT devices

GRT Antiserum, Fluorescent, Mycobacterium Tuberculosis: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GRT

FDA has decided no GRT device since 2007.

Median 510(k) review, days · GRT

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

Recalls per year · GRT

No recall names GRT since 2007.

Adverse event reports per year · GRT

3in 2009

2009: 3
2007high 3 (2009) · low 0 (2007)2025

MAUDE reports naming product code GRT, 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—00
20080—00
20090—03
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 Volu Sol Medical Industries

66 FDA decisions under this applicant name. See the company

  • K822128Volu-Sol Single Differential StainVolu Sol Medical Industries · 1982
  • K822127Volu-Sol Zenkers FixativeVolu Sol Medical Industries · 1982
  • K822129Volu-Sol Bovins FixativeVolu Sol Medical Industries · 1982
  • K822126Volu-Sol Carnoy FluidVolu Sol Medical Industries · 1982
  • K822037Volu-Sol Tap Water SubstituteVolu Sol Medical Industries · 1982

https://510kreport.com/device/K791452 · printed Nov 6, 2026

Cite this page

510(k) Report. “K791452: Agglutinotest-Tuberculosis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K791452

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