510(k) Report

FDA product code · Cardiovascular

Pulmonic Replacement Heart Valve

PALClass f21 CFR 870.39250 decisions0 recalls

0 FDA decisions. No recall names this code.

For open surgical replacement of malfunctioning pulmonic heart valve.

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 PAL 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 · PAL

FDA has decided no PAL device since 2007.

Median 510(k) review, days · PAL

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

Recalls per year · PAL

No recall names PAL since 2007.

Adverse event reports per year · PAL

No MAUDE report names PAL since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — PAL by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PAL? 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

Related product codes

Other codes under 21 CFR 870.3925.

DYE Replacement Heart-Valve