De Novo · Granted
GrantedPaxgene Blood Rna System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Preanalytix GmbH · NTW System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test
Granted on Apr 18, 2005 as a new device type through De Novo after a 49-day review. 2 later devices descend from it.
- Decided
- Apr 18, 2005
- Review
- 49 days
- Class
- Class II
- Product code
- NTW
- Recalls
- None
2 later devices descend from it, 2 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN050003 | Paxgene Blood Rna System | Preanalytix GmbH | 2005 | — |
| +1 | K082150 | Modification to Paxgene Blood Rna System | Preanalytix GmbH | 2009 | — |
| +1 | K113420 | Rnaretain | Asuragen, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NTW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
What does this lineage say?
- Of its descendants, K082150 (Preanalytix GmbH, 2009) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NTW devicesNTW System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NTW
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · NTW
Too few NTW 510(k)s in any year since 2007 to give a median.
Recalls per year · NTW
No recall names NTW since 2007.
Adverse event reports per year · NTW
11in 2025
MAUDE reports naming product code NTW, 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 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 44 |
| 2019 | 0 | — | 0 | 21 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 20 |
| 2024 | 0 | — | 0 | 12 |
| 2025 | 0 | — | 0 | 11 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/DEN050003 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN050003: Paxgene Blood Rna System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN050003
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026