PMA · Approved
Recalled · 2008Dimension (R) RXL Psa Flex (R) Reagent Cartridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Approved on Jul 5, 2001 through premarket approval, which rests on the device’s own clinical evidence after a 395-day review. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jul 5, 2001
- Review
- 395 days
- Class
- Class II
- Product code
- LTJ
- Recalls
- 2
1 later device descends from it, 1 citing it directly.
- This deviceP000021 Dimension (R) RXL Psa Flex (R) Reagent CartridgeSiemens Healthcare Diagnostics · 2001
- Descendant · cites it directly · 0 of its ownK031343 Tpsa Flex Reagent CartridgeDade Behring, Inc. · 2003
Most influential descendants
Showing 1 of 1 · See all- K031343Tpsa Flex Reagent CartridgeDade Behring, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P000021 | Dimension (R) RXL Psa Flex (R) Reagent Cartridge | Siemens Healthcare Diagnostics | 2001 | — |
| +1 | K031343 | Tpsa Flex Reagent Cartridge | Dade Behring, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LTJ? 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 LTJ device
- #1 K251630 Atellica IM Total PSA II (tPSAII)score 10.6 · 1 generation · no Class I recall
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031343 | Tpsa Flex Reagent Cartridge | 2003 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 24, 2008 | Not classified | Z-1606-2008 | Device Design | False Results: The product may exhibit falsely elevated results. The affected lots demonstrate sporadic variability in recovery of calibrator and quality control; therefore this issue may not be readily detected upon calibration or during… |
| Apr 21, 2003 | Not classified | Z-0873-03 | Other | test results may be inaccurate by 0.2 to 0.5 ng/mL |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K031343 (Dade Behring, Inc., 2003) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LTJ devicesLTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LTJ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LTJ
Too few LTJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LTJ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LTJ
14in 2025
MAUDE reports naming product code LTJ, 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 | 17 |
| 2008 | 0 | — | 3 | 57 |
| 2009 | 0 | — | 0 | 58 |
| 2010 | 0 | — | 2 | 34 |
| 2011 | 0 | — | 0 | 109 |
| 2012 | 0 | — | 0 | 101 |
| 2013 | 1 | — | 1 | 69 |
| 2014 | 0 | — | 0 | 19 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 2 | — | 0 | 8 |
| 2017 | 10 | — | 0 | 13 |
| 2018 | 7 | — | 0 | 8 |
| 2019 | 2 | — | 0 | 11 |
| 2020 | 1 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 8 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 2 | — | 0 | 17 |
| 2024 | 3 | — | 0 | 8 |
| 2025 | 3 | — | 1 | 14 |
| 2026 | 3 | — | 0 | — |
https://510kreport.com/device/P000021 · printed Nov 6, 2026
Cite this page
510(k) Report. “P000021: Dimension (R) RXL Psa Flex (R) Reagent Cartridge.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P000021
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026