510(k) Report

FDA product code · Microbiology

Antigen, B. Pertussis

GOXClass I21 CFR 866.3065510(k) exempt1 decision since 19790 recalls

FDA lists GOX 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. 1 FDA decision since 1979. 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, microbiology panel

Twenty years of GOX 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 · GOX

FDA has decided no GOX device since 2007.

Median 510(k) review, days · GOX

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

Recalls per year · GOX

No recall names GOX since 2007.

Adverse event reports per year · GOX

No MAUDE report names GOX 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—
FIG. 1 — GOX by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in GOX? 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

What has FDA decided in GOX lately?

  • K791454Agglutinotest-PertussisVolu Sol Medical Industries · 1979

The one GOX decision →

Related product codes

Other codes under 21 CFR 866.3065.

GOY Antisera, Agglutinating, B. Pertussis, AllJRW Antisera, Fluorescent, B. ParapertussisGOT Antigen, B. ParapertussisGOZ Antisera, Fluorescent, B. PertussisGOW Antisera, Agglutinating, B. Parapertussis