510(k) · Cleared
ClearedDiacap LO PS (10, 12, 15) and Diacap HI PS (10, 12, 15, 18, 20) Hemodialyzers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B. Braun Medizintechnologie GmbH · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Aug 17, 2007 after a 74-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Aug 17, 2007
- Review
- 74 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK071518 Diacap LO PS (10, 12, 15) and Diacap HI PS (10, 12, 15, 18, 20)…B. Braun Medizintechnologie GmbH · 2007
- Descendant · cites it directly · 1 of its ownK100334 Diacap Polysulfone Hiflo 23 Hemodilayzer , Model 72036811B. Braun Avitum AG · 2010
- Descendant · cites it directly · 0 of its ownK170574 Diacap Pro DialyzerB. Braun Avitum AG · 2017
- Descendant · cites it directly · 0 of its ownK143482 xevonta dialyzerB. Braun Avitum AG · 2016
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071518 | Diacap LO PS (10, 12, 15) and Diacap HI PS (10, 12, 15, 18, 20) Hemodialyzers | B. Braun Medizintechnologie GmbH | 2007 | — |
| +1 | K100334 | Diacap Polysulfone Hiflo 23 Hemodilayzer , Model 72036811 | B. Braun Avitum AG | 2010 | — |
| +1 | K170574 | Diacap Pro Dialyzer | B. Braun Avitum AG | 2017 | — |
| +1 | K143482 | xevonta dialyzer | B. Braun Avitum AG | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) 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 KDI? 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 KDI device
- #1 K243874 FX CorAL 60 (F00012969); FX CorAL 80…score 18.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (13)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Hemoflow F5 Named without a submission number | |
| * | — | Hemoflow F6 Named without a submission number | |
| * | — | Hemoflow F7 Named without a submission number | |
| * | — | Hemoflow F8 Named without a submission number | |
| * | — | Hemoflow F 50 NR Named without a submission number | |
| * | — | Hemoflow F 60 A Named without a submission number | |
| * | — | Hemoflow F 60 B Named without a submission number | |
| * | — | Hemoflow F 70 A Named without a submission number | |
| * | — | Hemoflow F 70 B Named without a submission number | |
| * | — | Hemoflow F 70 NR Named without a submission number | |
| * | — | Hemoflow F 80 A Named without a submission number | |
| * | — | Hemoflow F 80 B Named without a submission number | |
| * | — | Optiflux 200 A Named without a submission number |
What descends from it? (3)
3 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, K100334 (B. Braun Avitum AG, 2010) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KDI devicesKDI Dialyzer, High Permeability With Or Without Sealed Dialysate System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · KDI
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KDI
199in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KDI
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · KDI
2,786in 2025
MAUDE reports naming product code KDI, 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 | 11 | 91 | 4 | 916 |
| 2008 | 6 | 148 | 0 | 1,042 |
| 2009 | 4 | 236 | 3 | 522 |
| 2010 | 9 | 186 | 1 | 823 |
| 2011 | 5 | 85 | 4 | 2,270 |
| 2012 | 6 | 153 | 1 | 1,765 |
| 2013 | 11 | 247 | 2 | 2,360 |
| 2014 | 8 | 164 | 3 | 6,154 |
| 2015 | 5 | 69 | 5 | 4,182 |
| 2016 | 5 | 230 | 4 | 766 |
| 2017 | 8 | 188 | 1 | 963 |
| 2018 | 2 | — | 1 | 1,716 |
| 2019 | 4 | 263 | 6 | 1,587 |
| 2020 | 9 | 266 | 0 | 1,633 |
| 2021 | 2 | — | 2 | 1,944 |
| 2022 | 7 | 259 | 17 | 2,180 |
| 2023 | 7 | 157 | 8 (8) | 2,692 |
| 2024 | 7 | 235 | 4 (2) | 2,441 |
| 2025 | 9 | 199 | 2 | 2,786 |
| 2026 | 6 | 154 | 2 | — |
What is it indicated for?
Diacap LOPS (10, 12, 15) and Diacap HI PS (10, 12, 15, 18, 20) Hemodialyzers are designed for single use in acute and chronic hemodialysis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K071518 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071518: Diacap LO PS (10, 12, 15) and Diacap HI PS (10, 12, 15, 18, 20) Hemodialyzers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071518
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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