510(k) Report

FDA product code · Microbiology

Antiserum, Fluorescent, Francisella Tularensis

GSJClass II21 CFR 866.3280510(k) exempt1 decision since 19910 recalls

FDA lists GSJ 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 1991. 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 GSJ 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 · GSJ

FDA has decided no GSJ device since 2007.

Median 510(k) review, days · GSJ

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

Recalls per year · GSJ

No recall names GSJ since 2007.

Adverse event reports per year · GSJ

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

Planning a device in GSJ? 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 GSJ lately?

  • K914872Marlow Suction/Irrigation ProbesMarlo Surgical Technology · 1991

The one GSJ decision →

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Other codes under 21 CFR 866.3280.

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