FDA product code · Clinical chemistry

Controller, Closed-Loop Blood Glucose

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

LHEClass IIIPMA required2 decisions since 19800 recalls

2 FDA decisions since 1980. 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 LHE 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 · LHE

FDA has decided no LHE device since 2007.

Median 510(k) review, days · LHE

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

Recalls per year · LHE

No recall names LHE since 2007.

Adverse event reports per year · LHE

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

Planning a device in LHE? 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

Controller, Closed-Loop Blood Glucose

What has FDA decided in LHE lately?