FDA product code · Cardiovascular

Apical Closure Device

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

PNQClass II21 CFR 870.4510510(k) required1 decision since 20160 recalls

1 FDA decision since 2016. No recall names this code.

This device is intended for closure of cardiac apical tissue.

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, cardiovascular panel

Twenty years of PNQ 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 · PNQ

1in 2016

2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PNQ

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

Recalls per year · PNQ

No recall names PNQ since 2007.

Adverse event reports per year · PNQ

No MAUDE report names PNQ 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	1	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

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

Planning a device in PNQ? 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

Apical Closure Device

What has FDA decided in PNQ lately?