FDA product code · Obstetrics and gynecology

Prosthesis, Fallopian Tube

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

HFJClass II21 CFR 884.3650510(k) required1 decision since 19940 recalls

1 FDA decision since 1994. 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, obstetrics and gynecology panel

Twenty years of HFJ 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 · HFJ

FDA has decided no HFJ device since 2007.

Median 510(k) review, days · HFJ

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

Recalls per year · HFJ

No recall names HFJ since 2007.

Adverse event reports per year · HFJ

1in 2016

2007high 1 (2016) · low 0 (2007)2025

MAUDE reports naming product code HFJ, 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	—	1
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in HFJ? 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

Prosthesis, Fallopian Tube

What has FDA decided in HFJ lately?