FDA product code · Physical medicine

Device, Fluidized Therapy, Dry Heat

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

LBGClass II21 CFR 890.5500510(k) 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, physical medicine panel

Twenty years of LBG 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 · LBG

FDA has decided no LBG device since 2007.

Median 510(k) review, days · LBG

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

Recalls per year · LBG

No recall names LBG since 2007.

Adverse event reports per year · LBG

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

Planning a device in LBG? 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

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Device, Fluidized Therapy, Dry Heat

What has FDA decided in LBG lately?

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