FDA product code · Dental

Device, Electrical Dental Anesthesia

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

LWMClass U510(k) required15 decisions since 19870 recalls

15 FDA decisions since 1987. No recall names this code. The most-cited predicate is K182947, named by 2 later devices.

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 LWM 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 · LWM

2in 2020

2007high 2 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LWM

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

Recalls per year · LWM

No recall names LWM since 2007.

Adverse event reports per year · LWM

No MAUDE report names LWM since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	1	—	0
2020	2	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

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

Planning a device in LWM? 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, Electrical Dental Anesthesia

Which predicates do LWM devices cite most?

Which LWM devices have the deepest lineage?

What has FDA decided in LWM lately?