FDA product code · General hospital

Container, Frozen Donor Tissue Storage

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

LPZClass U510(k) required6 decisions since 19860 recalls

6 FDA decisions since 1986. No recall names this code. The most-cited predicate is K915471, named by 1 later device.

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, general hospital panel

Twenty years of LPZ 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 · LPZ

FDA has decided no LPZ device since 2007.

Median 510(k) review, days · LPZ

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

Recalls per year · LPZ

No recall names LPZ since 2007.

Adverse event reports per year · LPZ

1in 2025

2007high 24 (2017) · low 0 (2007)2025

MAUDE reports naming product code LPZ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	5
2012	—	2
2013	—	0
2014	—	0
2015	—	0
2016	—	16
2017	—	24
2018	—	23
2019	—	7
2020	—	16
2021	—	1
2022	—	0
2023	—	0
2024	—	1
2025	—	1
2026	—	—

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

Planning a device in LPZ? 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

Container, Frozen Donor Tissue Storage

Which predicates do LPZ devices cite most?

Which LPZ devices have the deepest lineage?

What has FDA decided in LPZ lately?