510(k) · Cleared
ClearedDdrelement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Swissray Medical AG · KPR System, X-Ray, Stationary
Cleared on Aug 23, 2011 after a 152-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Aug 23, 2011
- Review
- 152 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK110828 DdrelementSwissray Medical AG · 2011
- Descendant · cites it directly · 4 of its ownK123005 Ddrversa MotionSwissray Medical AG · 2012
- Descendant · 2 generations on · 3 of its ownK141381 DuradiagnostPhilips Healthcare (Suzhou) Co., Ltd. · 2014 · Recalled
- Descendant · 3 generations on · 1 of its ownK163410 DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Ltd. · 2017 · Recalled
- Descendant · 4 generations on · 0 of its ownK201725 DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Lit. · 2020 · Recalled
- Descendant · 3 generations on · 0 of its ownK201640 DuraDiagnostPhilips Healthcare (Suzhou) Co., Ltd. · 2020 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K123005Ddrversa MotionSwissray Medical AG · 2012 · cites it directly4descendants
- K141381DuradiagnostPhilips Healthcare (Suzhou) Co., Ltd. · 2014 · 2 generations on3descendants
- K163410DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Ltd. · 2017 · 3 generations on1descendant
- K201725DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Lit. · 2020 · 4 generations on0descendants
- K201640DuraDiagnostPhilips Healthcare (Suzhou) Co., Ltd. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K110828 | Ddrelement | Swissray Medical AG | 2011 | — |
| +1 | K123005 | Ddrversa Motion | Swissray Medical AG | 2012 | — |
| +2 | K141381 | Duradiagnost | Philips Healthcare (Suzhou) Co., Ltd. | 2014 | 7 |
| +3 | K163410 | DigitalDiagnost C50 | Philips Healthcare (Suzhou) Co., Ltd. | 2017 | 4 |
| +4 | K201725 | DigitalDiagnost C50 | Philips Healthcare (Suzhou) Co., Lit. | 2020 | 3 |
| +3 | K201640 | DuraDiagnost | Philips Healthcare (Suzhou) Co., Ltd. | 2020 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
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 KPR? 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 KPR device
- #1 K242119 Innovision-Exiiscore 17.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123005 | Ddrversa Motion | 2012 | 4 |
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, K123005 (Swissray Medical AG, 2012) has gone furthest, with 4 descendants of its own.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · KPR
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPR
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPR
7in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPR
39in 2025
MAUDE reports naming product code KPR, 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 | 12 | 31 | 10 | 120 |
| 2008 | 15 | 48 | 10 | 95 |
| 2009 | 9 | 35 | 5 | 61 |
| 2010 | 9 | 126 | 3 | 82 |
| 2011 | 9 | 152 | 5 | 103 |
| 2012 | 11 | 58 | 1 | 74 |
| 2013 | 5 | 163 | 5 | 24 |
| 2014 | 10 | 108 | 8 | 34 |
| 2015 | 18 | 81 | 1 | 59 |
| 2016 | 11 | 84 | 4 | 18 |
| 2017 | 6 | 75 | 3 | 31 |
| 2018 | 15 | 30 | 4 | 36 |
| 2019 | 12 | 33 | 1 | 77 |
| 2020 | 16 | 39 | 1 | 41 |
| 2021 | 6 | 55 | 0 | 37 |
| 2022 | 8 | 43 | 2 | 27 |
| 2023 | 9 | 76 | 4 | 39 |
| 2024 | 11 | 162 | 1 | 34 |
| 2025 | 8 | 155 | 7 | 39 |
| 2026 | 6 | 197 | 0 | — |
What is it indicated for?
The ddRElement is a Digital Radiography system developed to be used for Medical
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/K110828 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110828: Ddrelement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110828
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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