FDA product code · Obstetrics and gynecology

Drain, Cervical

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

HFLClass II21 CFR 884.3200510(k) exempt1 decision since 19910 recalls

FDA lists HFL as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 884.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 1991. 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 HFL 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 · HFL

FDA has decided no HFL device since 2007.

Median 510(k) review, days · HFL

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

Recalls per year · HFL

No recall names HFL since 2007.

Adverse event reports per year · HFL

No MAUDE report names HFL 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 — HFL by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in HFL? 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

Drain, Cervical

What has FDA decided in HFL lately?