FDA product code · Gastroenterology and urology

Bulb, Inflation, For Endoscope

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

FCYClass I21 CFR 876.1500510(k) exempt3 decisions since 19900 recalls

FDA lists FCY 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. 3 FDA decisions since 1990. No recall names this code. The most-cited predicate is K093718, named by 1 later device.

An endoscope bulb pressurizes the interior of an endoscope. The user identifies the presence of leaks in the endoscope by immersing in water and visually observing for bubbles.

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 FCY 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 · FCY

1in 2010

2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FCY

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

Recalls per year · FCY

No recall names FCY since 2007.

Adverse event reports per year · FCY

13in 2021

2007high 13 (2021) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	1	—	1
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	1
2019	0	—	0
2020	0	—	1
2021	0	—	13
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

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

Planning a device in FCY? 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 876.1500.

FAL Panendoscope (Urethroscope)FBO Cystourethroscope NWB Endoscope, Accessories, Narrow Band Spectrum KGD Scissors For Cystoscope FCZ Tube, Smoke Removal, Endoscopic FDW Esophagoscope, Rigid, Gastro-Urology FGS Carrier, Sponge, Endoscopic GCM Endoscope, Rigid GCN Endoscope, Prism FGA Kit, Nephroscope FAM Sigmoidoscope And Accessories, Flexible/Rigid GDB Endoscope, Fiber Optic

Bulb, Inflation, For Endoscope

Which predicates do FCY devices cite most?

What has FDA decided in FCY lately?

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