FDA product code · Radiology

Applicator, Hyperthermia, Deep Heating, Ultrasound

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

LNBClass IIIPMA required1 decision since 19890 recalls

1 FDA decision since 1989. 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 LNB 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 · LNB

FDA has decided no LNB device since 2007.

Median 510(k) review, days · LNB

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

Recalls per year · LNB

No recall names LNB since 2007.

Adverse event reports per year · LNB

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

Planning a device in LNB? 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

Applicator, Hyperthermia, Deep Heating, Ultrasound

What has FDA decided in LNB lately?