FDA product code · General and plastic surgery

Appliance, Facial Fracture, External

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

FYIClass I21 CFR 878.3250510(k) exempt4 decisions since 19790 recalls

FDA lists FYI as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 878.9 applies, such as a new intended use or a different fundamental technology. 4 FDA decisions since 1979. 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, general and plastic surgery panel

Twenty years of FYI 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 · FYI

FDA has decided no FYI device since 2007.

Median 510(k) review, days · FYI

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

Recalls per year · FYI

No recall names FYI since 2007.

Adverse event reports per year · FYI

2in 2025

2007high 8 (2023) · low 0 (2007)2025

MAUDE reports naming product code FYI, 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	—	4
2023	—	8
2024	—	6
2025	—	2
2026	—	—

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

Planning a device in FYI? 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

Appliance, Facial Fracture, External

What has FDA decided in FYI lately?