FDA product code · Cardiovascular
Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
3 FDA decisions since 2017. No recall names this code. The most-cited predicate is K192460, named by 1 later device.
Embolic protection for transcatheter intracardiac procedures
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PUM 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 · PUM
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · PUM
Too few PUM 510(k)s in any year since 2007 to give a median.
Recalls per year · PUM
No recall names PUM since 2007.
Adverse event reports per year · PUM
49in 2025
MAUDE reports naming product code PUM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 19 |
| 2019 | 0 | — | 0 | 48 |
| 2020 | 1 | — | 0 | 73 |
| 2021 | 0 | — | 0 | 43 |
| 2022 | 0 | — | 0 | 40 |
| 2023 | 0 | — | 0 | 24 |
| 2024 | 0 | — | 0 | 45 |
| 2025 | 0 | — | 0 | 49 |
| 2026 | 1 | — | 0 | — |
Planning a device in PUM? 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