De Novo · Granted
GrantedB·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brahms GmbH, Part of Thermo Fisher Scientific · QWH Prognostic Test For Development Or Progression Of Preeclampsia
Granted on May 18, 2023 as a new device type through De Novo after a 381-day review. 1 later device descends from it.
- Decided
- May 18, 2023
- Review
- 381 days
- Class
- Class II
- Product code
- QWH
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN220027 B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test SystemBrahms GmbH, Part of Thermo Fisher Scientific · 2023
- Descendant · cites it directly · 0 of its ownK241453 Elecsys sFlt-1 and Elecsys PlGFRoche Diagnostics · 2025
Most influential descendants
Showing 1 of 1 · See all- K241453Elecsys sFlt-1 and Elecsys PlGFRoche Diagnostics · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN220027 | B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System | Brahms GmbH, Part of Thermo Fisher Scientific | 2023 | — |
| +1 | K241453 | Elecsys sFlt-1 and Elecsys PlGF | Roche Diagnostics | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QWH? 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 QWH device
- #1 K241453 Elecsys sFlt-1 and Elecsys PlGFscore 8.8 · 1 generation · no Class I recall
Does it have a predicate?
De Novo 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 |
|---|---|---|---|
| K241453 | Elecsys sFlt-1 and Elecsys PlGF | 2025 | 0 |
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, K241453 (Roche Diagnostics, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QWH devicesQWH Prognostic Test For Development Or Progression Of Preeclampsia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QWH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QWH
Too few QWH 510(k)s in any year since 2007 to give a median.
Recalls per year · QWH
No recall names QWH since 2007.
Adverse event reports per year · QWH
2in 2025
MAUDE reports naming product code QWH, 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 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The B·R·A·H·M·S PlGF plus KRYPTOR is to be used in conjunction with the B·R·A·H·M·S sFlt-1 KRYPTOR along with other laboratory tests and clinical assessments to aid in the risk assessment of pregnant women (singleton pregnancies between gestational age 23+0 to 34+6/7 weeks) hospitalized for hypertensive disorders of pregnancy (preeclampsia, chronic hypertension with or without superimposed preeclampsia, or gestational hypertension) for progression to preeclampsia with severe features (as defined by the American College of Obstetricians and Gynecologists (ACOG) guidelines) within 2 weeks of presentation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN220027 · printed Nov 4, 2026
Cite this page
510(k) Report. “DEN220027: B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/DEN220027
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026