FDA product code · Clinical chemistry

Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions

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

LMYClass IIIPMA required1 decision since 19820 recalls

1 FDA decision since 1982. 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, clinical chemistry panel

Twenty years of LMY 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 · LMY

FDA has decided no LMY device since 2007.

Median 510(k) review, days · LMY

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

Recalls per year · LMY

No recall names LMY since 2007.

Adverse event reports per year · LMY

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

Planning a device in LMY? 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

Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions

What has FDA decided in LMY lately?