510(k) · Cleared
ClearedFresenius Hemoflow, Various Models
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius USA, Inc. · FJI Dialyzer, Capillary, Hollow Fiber
Cleared on Aug 23, 1994 after a 634-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Aug 23, 1994
- Review
- 634 days
- Class
- Class II
- Product code
- FJI
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK926005 Fresenius Hemoflow, Various ModelsFresenius USA, Inc. · 1994
- Descendant · cites it directly · 2 of its ownK131381 Elisio-H HemodialyzerNipro Medical Corporation · 2013
- Descendant · 2 generations on · 1 of its ownK140191 Elisio-H HemodialyzerNipro Medical Corporation · 2014
- Descendant · 3 generations on · 0 of its ownK260533 Elisio™-HNipro Medical Corporation · 2026
- Descendant · cites it directly · 0 of its ownK122952 Nipro Pureflux-L HemodialyzerNipro Medical Corporation · 2013
Most influential descendants
Showing 4 of 4 · See all- K131381Elisio-H HemodialyzerNipro Medical Corporation · 2013 · cites it directly2descendants
- K140191Elisio-H HemodialyzerNipro Medical Corporation · 2014 · 2 generations on1descendant
- K260533Elisio™-HNipro Medical Corporation · 2026 · 3 generations on0descendants
- K122952Nipro Pureflux-L HemodialyzerNipro Medical Corporation · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K926005 | Fresenius Hemoflow, Various Models | Fresenius USA, Inc. | 1994 | — |
| +1 | K131381 | Elisio-H Hemodialyzer | Nipro Medical Corporation | 2013 | — |
| +2 | K140191 | Elisio-H Hemodialyzer | Nipro Medical Corporation | 2014 | — |
| +3 | K260533 | Elisio™-H | Nipro Medical Corporation | 2026 | — |
| +1 | K122952 | Nipro Pureflux-L Hemodialyzer | Nipro Medical Corporation | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2026 | 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 FJI? 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? (4)
2 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, K131381 (Nipro Medical Corporation, 2013) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FJI devicesFJI Dialyzer, Capillary, Hollow Fiber: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FJI
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · FJI
Too few FJI 510(k)s in any year since 2007 to give a median.
Recalls per year · FJI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FJI
145in 2025
MAUDE reports naming product code FJI, 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 | 17 |
| 2008 | 0 | — | 0 | 11 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 32 |
| 2011 | 0 | — | 0 | 47 |
| 2012 | 0 | — | 0 | 211 |
| 2013 | 1 | — | 0 | 553 |
| 2014 | 0 | — | 0 | 633 |
| 2015 | 0 | — | 0 | 561 |
| 2016 | 0 | — | 0 | 562 |
| 2017 | 0 | — | 0 | 182 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 1 | — | 0 | 20 |
| 2020 | 0 | — | 0 | 16 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 51 |
| 2024 | 0 | — | 0 | 152 |
| 2025 | 0 | — | 1 | 145 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K926005 · printed Nov 6, 2026
Cite this page
510(k) Report. “K926005: Fresenius Hemoflow, Various Models.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K926005
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026