FDA product code · General and plastic surgery
Image Processing Device For Estimation Of External Blood Loss
6 FDA decisions since 2014. 510(k) reviews decided 2021–2025 took a median of 167 days (half between 167 and 167). No recall names this code. The most-cited predicate is DEN130015, named by 2 later devices.
An image processing device for estimation of external blood loss is a device to be used as an aid in estimation of patient external blood loss. The device may include software and/or hardware that is used to process images capturing externally lost blood to estimate the hemoglobin mass and/or the blood volume present in the images.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PBZ 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 · PBZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PBZ
Too few PBZ 510(k)s in any year since 2007 to give a median.
Recalls per year · PBZ
No recall names PBZ since 2007.
Adverse event reports per year · PBZ
6in 2025
MAUDE reports naming product code PBZ, 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 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 246 |
| 2024 | 1 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 1 | — | 0 | — |
Planning a device in PBZ? 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