FDA product code · Gastroenterology and urology

Sound, Metal, Interconnected

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

FBSClass I21 CFR 876.4590510(k) exempt1 decision since 19960 recalls

FDA lists FBS as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 876.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 1996. 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, gastroenterology and urology panel

Twenty years of FBS 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 · FBS

FDA has decided no FBS device since 2007.

Median 510(k) review, days · FBS

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

Recalls per year · FBS

No recall names FBS since 2007.

Adverse event reports per year · FBS

1in 2025

2007high 1 (2025) · low 0 (2007)2025

MAUDE reports naming product code FBS, 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	—	0
2025	—	1
2026	—	—

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

Planning a device in FBS? 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

Sound, Metal, Interconnected

What has FDA decided in FBS lately?