FDA product code · General hospital

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

FPFClass I21 CFR 880.6085510(k) exempt1 decision since 19790 recalls

FDA lists FPF 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. 1 FDA decision 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 hospital panel

Twenty years of FPF 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 · FPF

FDA has decided no FPF device since 2007.

Median 510(k) review, days · FPF

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

Recalls per year · FPF

No recall names FPF since 2007.

Adverse event reports per year · FPF

1in 2024

2007high 4 (2023) · low 0 (2007)2025

MAUDE reports naming product code FPF, 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	—	1
2010	—	0
2011	—	0
2012	—	3
2013	—	1
2014	—	0
2015	—	1
2016	—	1
2017	—	2
2018	—	0
2019	—	3
2020	—	1
2021	—	0
2022	—	2
2023	—	4
2024	—	1
2025	—	0
2026	—	—

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

Planning a device in FPF? 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

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What has FDA decided in FPF lately?