FDA product code · Cardiovascular
Temporary Non-Roller Type Right Heart Support Blood Pump
1 FDA decision since 2017. 3 recalls name this code, 2 of them Class I.
Providing temporary partial or full right heart circulatory support.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PYX 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 · PYX
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PYX
Too few PYX 510(k)s in any year since 2007 to give a median.
Recalls per year · PYX
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · PYX
545in 2025
MAUDE reports naming product code PYX, 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 | 2 | — | 0 | 2 |
| 2018 | 7 | — | 0 | 10 |
| 2019 | 10 | — | 0 | 10 |
| 2020 | 8 | — | 0 | 10 |
| 2021 | 8 | — | 0 | 7 |
| 2022 | 13 | — | 0 | 9 |
| 2023 | 4 | — | 1 | 90 |
| 2024 | 1 | — | 2 (2) | 1,030 |
| 2025 | 7 | — | 0 | 545 |
| 2026 | 2 | — | 0 | — |
Planning a device in PYX? 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) ReportRelated product codes
Other codes under 21 CFR 870.4360.