Histoplasma Yeast Anti #CF10021X

K791393510(k) TraditionalCleared Aug 16, 197936-day reviewClass II21 CFR 866.3320Recalls 1

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

Immuno-Mycologics, Inc. · GMJ Antigens, Histoplasma Capsulatum, All

Cleared on Aug 16, 1979 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled once.

Decided: Aug 16, 1979
Review: 36 days
Class: Class II
Product code: GMJ
Recalls: 1
Predicates: 0

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

FIG. 1 — Lineage of K791393Source: FDA 510(k) database · How lineage is built

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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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)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 9, 2016	Class II	Z-2040-2016	Process control	The device was found to have bacterial contamination.

No ancestor or descendant has a Class I recall.

How does its category compare?

All GMJ devices

GMJ Antigens, Histoplasma Capsulatum, All: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GMJ

FDA has decided no GMJ device since 2007.

Median 510(k) review, days · GMJ

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

Recalls per year · GMJ

No recall names GMJ since 2007.

Adverse event reports per year · GMJ

No MAUDE report names GMJ since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K791393 · printed Nov 5, 2026

Cite this page

510(k) Report. “K791393: Histoplasma Yeast Anti #CF10021X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K791393

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Record history

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