FDA product code · Hematology
Platelet And Plasma Separator For Bone Graft Handling
0 FDA decisions. No recall names this code.
Preparation of autologous platelet rich plasma from a small sample of peripheral blood for mixing with bone graft to improve handling characteristics.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of ORG 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 · ORG
FDA has decided no ORG device since 2007.
Median 510(k) review, days · ORG
Too few ORG 510(k)s in any year since 2007 to give a median.
Recalls per year · ORG
No recall names ORG since 2007.
Adverse event reports per year · ORG
106in 2025
MAUDE reports naming product code ORG, 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 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 10 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 20 |
| 2021 | 0 | — | 0 | 25 |
| 2022 | 0 | — | 0 | 25 |
| 2023 | 0 | — | 0 | 83 |
| 2024 | 0 | — | 0 | 117 |
| 2025 | 0 | — | 0 | 106 |
| 2026 | 0 | — | 0 | — |
Planning a device in ORG? 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 864.9245.