FDA product code · Gastroenterology and urology

Device, Testicular Hypothermia

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

LOAClass IIIPMA required1 decision since 19840 recalls

1 FDA decision since 1984. 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, gastroenterology and urology panel

Twenty years of LOA 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 · LOA

FDA has decided no LOA device since 2007.

Median 510(k) review, days · LOA

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

Recalls per year · LOA

No recall names LOA since 2007.

Adverse event reports per year · LOA

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

Planning a device in LOA? 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

Device, Testicular Hypothermia

What has FDA decided in LOA lately?