FDA product code · Radiology

System, Telethermographic (Sole Diagnostic Screen)

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

LHPClass III21 CFR 884.2980PMA required0 decisions0 recalls

0 FDA decisions. 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, radiology panel

Twenty years of LHP 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 · LHP

FDA has decided no LHP device since 2007.

Median 510(k) review, days · LHP

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

Recalls per year · LHP

No recall names LHP since 2007.

Adverse event reports per year · LHP

1in 2025

2007high 2 (2018) · low 0 (2007)2025

MAUDE reports naming product code LHP, 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	—	1
2015	—	0
2016	—	0
2017	—	1
2018	—	2
2019	—	1
2020	—	0
2021	—	1
2022	—	0
2023	—	0
2024	—	0
2025	—	1
2026	—	—

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

Planning a device in LHP? 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

Related product codes

Other codes under 21 CFR 884.2980.

LHQ System, Telethermographic (Adjunctive Use)IYM System, Telethermographic, Infrared