FDA product code · Gastroenterology and urology

Dilator, Urethral, Mechanical

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

FAHClass II21 CFR 876.5520510(k) required4 decisions since 19830 recalls

4 FDA decisions since 1983. 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 FAH 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 · FAH

FDA has decided no FAH device since 2007.

Median 510(k) review, days · FAH

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

Recalls per year · FAH

No recall names FAH since 2007.

Adverse event reports per year · FAH

No MAUDE report names FAH since 2007.

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	—	0
2026	—	—

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

Planning a device in FAH? 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 876.5520.

KOE Dilator, Urethral FBR Urethrometer FAX Bougie, Urological FBW Filiform And Filiform Follower FBX Sound, Urethral, Metal Or Plastic

Dilator, Urethral, Mechanical

What has FDA decided in FAH lately?

Related product codes