FDA product code · Obstetrics and gynecology

Transducer, Ultrasonic, Obstetric

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

HGLClass II21 CFR 884.2960510(k) required36 decisions since 19770 recalls

36 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 HGL 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 · HGL

FDA has decided no HGL device since 2007.

Median 510(k) review, days · HGL

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

Recalls per year · HGL

No recall names HGL since 2007.

Adverse event reports per year · HGL

16in 2025

2007high 16 (2025) · low 0 (2007)2025

MAUDE reports naming product code HGL, 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	—	0
2017	—	0
2018	—	2
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	14
2025	—	16
2026	—	—

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

Planning a device in HGL? 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

Transducer, Ultrasonic, Obstetric

What has FDA decided in HGL lately?