510(k) · Cleared
Recalled · Class II · 2014Fresenius Optiflux 200NR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care North America · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Aug 25, 2000 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it. It has been recalled 6 times.
- Decided
- Aug 25, 2000
- Review
- 30 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 6
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK002277 Fresenius Optiflux 200NRFresenius Medical Care North America · 2000
- Descendant · cites it directly · 1 of its ownK043244 Fresenius Optiflux F20NR, FF18NR, F16NRFresenius Medical Care North America · 2004 · Recalled
- Descendant · cites it directly · 1 of its ownK031378 Fresenius Ultraflux HemodialyzerFresenius Medical Care North America · 2003
- Descendant · 2 generations on · 0 of its ownK122952 Nipro Pureflux-L HemodialyzerNipro Medical Corporation · 2013
- Descendant · cites it directly · 0 of its ownK034064 Fresenius Ultraflo HPX HemodialyzerFresenius Medical Care North America · 2004
- Descendant · cites it directly · 0 of its ownK030050 Toraysulfone Dialyzer, BS-L SeriesToray Industries (America), Inc. · 2003
Most influential descendants
Showing 5 of 5 · See all- K043244Fresenius Optiflux F20NR, FF18NR, F16NRFresenius Medical Care North America · 2004 · cites it directly1descendant
- K031378Fresenius Ultraflux HemodialyzerFresenius Medical Care North America · 2003 · cites it directly1descendant
- K122952Nipro Pureflux-L HemodialyzerNipro Medical Corporation · 2013 · 2 generations on0descendants
- K034064Fresenius Ultraflo HPX HemodialyzerFresenius Medical Care North America · 2004 · cites it directly0descendants
- K030050Toraysulfone Dialyzer, BS-L SeriesToray Industries (America), Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002277 | Fresenius Optiflux 200NR | Fresenius Medical Care North America | 2000 | — |
| +1 | K043244 | Fresenius Optiflux F20NR, FF18NR, F16NR | Fresenius Medical Care North America | 2004 | 1 |
| +1 | K031378 | Fresenius Ultraflux Hemodialyzer | Fresenius Medical Care North America | 2003 | — |
| +2 | K122952 | Nipro Pureflux-L Hemodialyzer | Nipro Medical Corporation | 2013 | — |
| +1 | K034064 | Fresenius Ultraflo HPX Hemodialyzer | Fresenius Medical Care North America | 2004 | — |
| +1 | K030050 | Toraysulfone Dialyzer, BS-L Series | Toray Industries (America), Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2013 | 1 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 4, 2014 | Class II | Z-1099-2014 | Under Investigation by firm | Dialysate Port Leak During Priming of the Dialyzers |
| Feb 4, 2014 | Class II | Z-1101-2014 | Under Investigation by firm | Dialysate Port Leak During Priming of the Dialyzers |
| Feb 4, 2014 | Class II | Z-1103-2014 | Under Investigation by firm | Dialysate Port Leak During Priming of the Dialyzers |
| May 14, 2010 | Not classified | Z-1951-2010 | Process control | Hemodialyzer may leak at the header/end cap |
| Dec 3, 2007 | Not classified | Z-0738-2008 | Process control | Leaking: the Dialyzer may leak at the header resulting in small amounts of blood loss. |
| Nov 28, 2005 | Not classified | Z-0333-06 | Other | Mislabeled: Inner product mislabeled as F180NR (Catalog Number 0500318N) instead of F160NR |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K043244 (Fresenius Medical Care North America, 2004) 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.
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 | — |
https://510kreport.com/device/K002277 · printed Nov 4, 2026
Cite this page
510(k) Report. “K002277: Fresenius Optiflux 200NR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K002277
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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