FDA product code · Clinical chemistry

Hyaline Membrane Disease Assay

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

LTCClass IIIPathway set case by case1 decision since 19850 recalls

1 FDA decision since 1985. 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 LTC 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 · LTC

FDA has decided no LTC device since 2007.

Median 510(k) review, days · LTC

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

Recalls per year · LTC

No recall names LTC since 2007.

Adverse event reports per year · LTC

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

Planning a device in LTC? 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

Hyaline Membrane Disease Assay

What has FDA decided in LTC lately?