510(k) Report

510(k) · Cleared

Cleared

Affirm VP Microbial ID Test for Trichomonas Vagina

K922457510(k) TraditionalCleared Sep 25, 1992122-day reviewClass I21 CFR 866.2660

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

Microprobe Corp. · MJK Dna Probe, Trichomonas Vaginalis

Cleared on Sep 25, 1992 after a 122-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Sep 25, 1992
Review
122 days
Class
Class I
Product code
MJK
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K922457Source: 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 MJK? 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 lists a 510(k) statement for it but has not posted the file, 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 MJK devices

MJK Dna Probe, Trichomonas Vaginalis: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MJK

FDA has decided no MJK device since 2007.

Median 510(k) review, days · MJK

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

Recalls per year · MJK

1in 2008

2007: 32008: 1
2007high 3 (2007) · low 0 (2009)2026

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

Adverse event reports per year · MJK

3in 2025

2012: 32013: 82014: 322015: 62016: 22018: 32022: 12023: 62024: 32025: 3
2007high 32 (2014) · low 0 (2007)2025

MAUDE reports naming product code MJK, 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—30
20080—10
20090—00
20100—00
20110—00
20120—03
20130—08
20140—032
20150—06
20160—02
20170—00
20180—03
20190—00
20200—00
20210—00
20220—01
20230—06
20240—03
20250—03
20260—0—

More from Microprobe Corp.

6 FDA decisions under this applicant name. See the company

  • K931151Affirm (TM) Vpiii Microbial Ident Test for CandidaMicroprobe Corp. · 1993
  • K931374Affirm Vpiii Microbial Identification TestMicroprobe Corp. · 19931 recall
  • K923133Affirm/VP Ident.Test G.Vaginalis & T.VaginalisMicroprobe Corp. · 1992
  • K923268Affirm ProcessorMicroprobe Corp. · 1992
  • K920536Affirm VP Sample Collection SetMicroprobe Corp. · 1992

https://510kreport.com/device/K922457 · printed Nov 5, 2026

Cite this page

510(k) Report. “K922457: Affirm VP Microbial ID Test for Trichomonas Vagina.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K922457

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