FDA product code · Obstetrics and gynecology

Stethoscope, Fetal

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

HGNClass I21 CFR 884.2900510(k) exempt2 decisions since 19770 recalls

FDA lists HGN 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. 2 FDA decisions since 1977. 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 HGN 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 · HGN

FDA has decided no HGN device since 2007.

Median 510(k) review, days · HGN

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

Recalls per year · HGN

No recall names HGN since 2007.

Adverse event reports per year · HGN

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

Planning a device in HGN? 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

Stethoscope, Fetal

What has FDA decided in HGN lately?