510(k) Report

FDA product code · Clinical chemistry

Test, Vaginal, Bacterial Sialidase

MXBClass I21 CFR 866.2660510(k) exempt2 decisions since 20000 recalls

FDA lists MXB as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 866.9 applies, such as a new intended use or a different fundamental technology. 2 FDA decisions since 2000. No recall names this code.

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

FIG. A — Illustration, clinical chemistry panel

Twenty years of MXB at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · MXB

FDA has decided no MXB device since 2007.

Median 510(k) review, days · MXB

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

Recalls per year · MXB

No recall names MXB since 2007.

Adverse event reports per year · MXB

1in 2019

2008: 12019: 1
2007high 1 (2008) · low 0 (2007)2025

MAUDE reports naming product code MXB, 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—01
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—01
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — MXB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MXB? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which MXB devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K993732BvblueGryphus Diagnostics, LLC · 20001generation

What has FDA decided in MXB lately?

  • K050755Modification to BvblueGryphus Diagnostics, LLC · 20051 recall
  • K993732BvblueGryphus Diagnostics, LLC · 2000

All 2 MXB decisions →

Related product codes

Other codes under 21 CFR 866.2660.

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