FDA product code · Dental

Solution, Removal, Carries

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

LMWClass IIIPMA required2 decisions since 19840 recalls

2 FDA decisions 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, dental panel

Twenty years of LMW 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 · LMW

FDA has decided no LMW device since 2007.

Median 510(k) review, days · LMW

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

Recalls per year · LMW

No recall names LMW since 2007.

Adverse event reports per year · LMW

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

Planning a device in LMW? 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

Solution, Removal, Carries

What has FDA decided in LMW lately?