PMA · Approved
ApprovedDimension Fpsa Flex Reagent Cartridge and Dimension T/F Psa Calibrator for Dimension RXL and Xpand Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · MTG Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
Approved on Jan 24, 2003 through premarket approval, which rests on the device’s own clinical evidence after a 203-day review.
- Decided
- Jan 24, 2003
- Review
- 203 days
- Class
- Class III
- Product code
- MTG
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P020027 has 41 supplements since 2003: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2003 | 1 |
| 2005 | 3 |
| 2007 | 2 |
| 2008 | 2 |
| 2010 | 5 |
| 2011 | 3 |
| 2012 | 3 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 2 |
| 2017 | 5 |
| 2018 | 4 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 2 |
| 2023 | 1 |
| 2025 | 2 |
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 MTG? 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?
PMA decisions do not claim a predicate device.
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 MTG devicesMTG Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MTG
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MTG
Too few MTG 510(k)s in any year since 2007 to give a median.
Recalls per year · MTG
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MTG
20in 2025
MAUDE reports naming product code MTG, 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 | 7 | — | 0 | 0 |
| 2008 | 7 | — | 1 | 0 |
| 2009 | 3 | — | 0 | 0 |
| 2010 | 9 | — | 0 | 0 |
| 2011 | 25 | — | 1 | 3 |
| 2012 | 17 | — | 0 | 4 |
| 2013 | 12 | — | 0 | 3 |
| 2014 | 13 | — | 0 | 1 |
| 2015 | 7 | — | 0 | 9 |
| 2016 | 3 | — | 0 | 5 |
| 2017 | 9 | — | 0 | 8 |
| 2018 | 7 | — | 0 | 12 |
| 2019 | 9 | — | 0 | 13 |
| 2020 | 13 | — | 0 | 6 |
| 2021 | 7 | — | 0 | 9 |
| 2022 | 4 | — | 0 | 4 |
| 2023 | 9 | — | 0 | 5 |
| 2024 | 3 | — | 0 | 8 |
| 2025 | 6 | — | 0 | 20 |
| 2026 | 6 | — | 0 | — |
https://510kreport.com/device/P020027 · printed Nov 6, 2026
Cite this page
510(k) Report. “P020027: Dimension Fpsa Flex Reagent Cartridge and Dimension T/F Psa Calibrator for Dimension RXL and Xpand Systems.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P020027
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026