510(k) · Cleared
ClearedMultiple (Izon Dna Blood Collection Kit)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Izon Business Products, Inc. · PJE Blood/Plasma Collection Device For Dna Testing
Cleared on Apr 9, 2001 after a 66-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 9, 2001
- Review
- 66 days
- Class
- Class II
- Product code
- PJE
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PJE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PJE device
- #1 K231469 PAXgene® Blood DNA Tubescore 6.1 · 3 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All PJE devicesPJE Blood/Plasma Collection Device For Dna Testing: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
What is it indicated for?
A blood collection kit for DNA is a devioe intended for medical purposes to collect and to handle blood specimens prior to further testing. This type of device may include blood collection tubes, vials, systems, or vacuuin ssmple tubes.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K010328 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010328: Multiple (Izon Dna Blood Collection Kit).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010328
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026