FDA product code · Cardiovascular
Temporary Non-Roller Type Left Heart Support Blood Pump
1 FDA decision since 2015. 18 recalls name this code, 10 of them Class I.
A blood pump that provides temporary full or partial left heart 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 OZD 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 · OZD
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OZD
Too few OZD 510(k)s in any year since 2007 to give a median.
Recalls per year · OZD
9so far in 2026, the most since 2007
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · OZD
9,726in 2025
MAUDE reports naming product code OZD, 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 | — | 1 (1) | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 5 | — | 0 | 0 |
| 2016 | 8 | — | 0 | 18 |
| 2017 | 12 | — | 0 | 109 |
| 2018 | 17 | — | 0 | 149 |
| 2019 | 19 | — | 2 | 300 |
| 2020 | 12 | — | 0 | 341 |
| 2021 | 13 | — | 0 | 567 |
| 2022 | 15 | — | 0 | 542 |
| 2023 | 8 | — | 3 (1) | 3,849 |
| 2024 | 5 | — | 0 | 18,590 |
| 2025 | 11 | — | 3 (2) | 9,726 |
| 2026 | 3 | — | 9 (6) | — |
Planning a device in OZD? 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