FDA product code · General hospital

Pad, Neonatal Eye

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

FOKClass I21 CFR 880.5270510(k) exempt5 decisions since 19810 recalls

FDA lists FOK as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 880.9 applies, such as a new intended use or a different fundamental technology. 5 FDA decisions since 1981. 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 hospital panel

Twenty years of FOK 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 · FOK

FDA has decided no FOK device since 2007.

Median 510(k) review, days · FOK

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

Recalls per year · FOK

No recall names FOK since 2007.

Adverse event reports per year · FOK

1in 2025

2007high 8 (2016) · low 0 (2008)2025

MAUDE reports naming product code FOK, 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	—	1
2008	—	0
2009	—	0
2010	—	0
2011	—	2
2012	—	1
2013	—	3
2014	—	1
2015	—	0
2016	—	8
2017	—	3
2018	—	1
2019	—	2
2020	—	1
2021	—	2
2022	—	0
2023	—	0
2024	—	0
2025	—	1
2026	—	—

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

Planning a device in FOK? 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

Pad, Neonatal Eye

What has FDA decided in FOK lately?