510(k) · Cleared
ClearedCT Celluloser Triacetate Hollow Fiber Dialyzer (CT-110G/CT-190G)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · MSF Hemodialyzer, Re-Use, High Flux
Cleared on Jan 11, 1998 after a 324-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 29 later devices descend from it.
- Decided
- Jan 11, 1998
- Review
- 324 days
- Class
- Class II
- Product code
- MSF
- Recalls
- None
- Predicates
- 0
29 later devices descend from it, 2 citing it directly.
- This deviceK970663 CT Celluloser Triacetate Hollow Fiber Dialyzer (CT-110G/CT-190G)Baxter Healthcare Corp · 1998
- Descendant · cites it directly · 27 of its ownK030974 Exeltra High Flux Dialyzer, Models 150 & 170Baxter Healthcare Corp · 2003
- Descendant · 2 generations on · 26 of its ownK062079 Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2006
- Descendant · 3 generations on · 20 of its ownK083778 Xenium XPH, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2009
- Descendant · 3 generations on · 16 of its ownK082414 Optiflux F250NR, Model 0500325EFresenius Medical Care North America · 2008 · Recalled
- Descendant · 4 generations on · 13 of its ownK123262 Optiflux Ultra DialyzerFresenius Medical Care North America · 2014
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K030974Exeltra High Flux Dialyzer, Models 150 & 170Baxter Healthcare Corp · 2003 · cites it directly27descendants
- K062079Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2006 · 2 generations on26descendants
- K083778Xenium XPH, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2009 · 3 generations on20descendants
- K082414Optiflux F250NR, Model 0500325EFresenius Medical Care North America · 2008 · 3 generations on16descendants
- K123262Optiflux Ultra DialyzerFresenius Medical Care North America · 2014 · 4 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970663 | CT Celluloser Triacetate Hollow Fiber Dialyzer (CT-110G/CT-190G) | Baxter Healthcare Corp | 1998 | — |
| +1 | K030974 | Exeltra High Flux Dialyzer, Models 150 & 170 | Baxter Healthcare Corp | 2003 | — |
| +2 | K062079 | Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210 | Baxter Healthcare Corporation | 2006 | — |
| +3 | K083778 | Xenium XPH, Models 110, 130, 150, 170, 190 and 210 | Baxter Healthcare Corporation | 2009 | — |
| +3 | K082414 | Optiflux F250NR, Model 0500325E | Fresenius Medical Care North America | 2008 | 3 |
| +4 | K123262 | Optiflux Ultra Dialyzer | Fresenius Medical Care North America | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 6 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MSF? 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
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (29)
See all 292 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, K030974 (Baxter Healthcare Corp, 2003) has gone furthest, with 27 descendants of its own.
How does its category compare?
All MSF devicesMSF Hemodialyzer, Re-Use, High Flux: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MSF
FDA has decided no MSF device since 2007.
Median 510(k) review, days · MSF
Too few MSF 510(k)s in any year since 2007 to give a median.
Recalls per year · MSF
No recall names MSF since 2007.
Adverse event reports per year · MSF
1in 2023
MAUDE reports naming product code MSF, 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 | 509 |
| 2008 | 0 | — | 0 | 659 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 16 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 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 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K970663 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970663: CT Celluloser Triacetate Hollow Fiber Dialyzer (CT-110G/CT-190G).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970663
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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