FDA product code · Clinical chemistry
Blood/Plasma Collection Device For Dna Testing
8 FDA decisions since 1998. 510(k) reviews decided 2021–2025 took a median of 30 days (half between 30 and 30). No recall names this code. The most-cited predicate is K972075, named by 5 later devices.
A blood collection device for DNA testing is an in vitro diagnostics device intended to collect and transport blood specimens to the laboratory for clinical DNA testing.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PJE 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 · PJE
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PJE
Too few PJE 510(k)s in any year since 2007 to give a median.
Recalls per year · PJE
No recall names PJE since 2007.
Adverse event reports per year · PJE
257in 2025
MAUDE reports naming product code PJE, 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 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 27 |
| 2019 | 0 | — | 0 | 12 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 1 | — | 0 | 63 |
| 2024 | 0 | — | 0 | 168 |
| 2025 | 0 | — | 0 | 257 |
| 2026 | 0 | — | 0 | — |
Planning a device in PJE? 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 862.1675.