FDA product code · Microbiology

Antiserum, Pseudomonas Pseudomallei

Name: FDA decisions, review times, recalls and adverse event reports for product code GST
Creator: 510(k) Report

GSTClass II21 CFR 866.3415510(k) exempt0 decisions0 recalls

FDA lists GST 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. 0 FDA decisions. 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 GST 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 · GST

FDA has decided no GST device since 2007.

Median 510(k) review, days · GST

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

Recalls per year · GST

No recall names GST since 2007.

Adverse event reports per year · GST

1in 2024

2007high 1 (2024) · low 0 (2007)2025

MAUDE reports naming product code GST, not matched to any one device; reports are not rates.

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	—	1
2025	—	0
2026	—	—

FIG. 1 — GST by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in GST? 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

Related product codes

Other codes under 21 CFR 866.3415.

GSR Antisera, Fluorescent, Pseudomonas Pseudomallei GSS Antisera, Fluorescent, Pseudomonas Aeruginosa