510(k) · Cleared
ClearedCuprophan and Hemophan Hollow Fiber Dialyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Haidylena Medical Egypt · FJI Dialyzer, Capillary, Hollow Fiber
Cleared on Dec 29, 1998 as substantially equivalent to K864831 (Cobe Laboratories, Inc., 1987) after a 176-day review. Its family tree reaches back 1 generation to 1987. 1 later device descends from it.
- Decided
- Dec 29, 1998
- Review
- 176 days
- Class
- Class II
- Product code
- FJI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K864831 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK864831 Cobe Centrysystem 145E,160E,175E,190E DialyzersCobe Laboratories, Inc. · 1987
- This deviceK982337 Cuprophan and Hemophan Hollow Fiber DialyzerHaidylena Medical Egypt · 1998
- Descendant · cites it directly · 0 of its ownK991908 Idemsa Hemophan Hollow Fiber DialyzersIdemsa · 2000
Most influential descendants
Showing 1 of 1 · See all- K991908Idemsa Hemophan Hollow Fiber DialyzersIdemsa · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K864831 | Cobe Centrysystem 145E,160E,175E,190E Dialyzers | Cobe Laboratories, Inc. | 1987 | — |
| 0 (this device) | K982337 | Cuprophan and Hemophan Hollow Fiber Dialyzer | Haidylena Medical Egypt | 1998 | — |
| +1 | K991908 | Idemsa Hemophan Hollow Fiber Dialyzers | Idemsa | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 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? (3)
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 |
|---|---|---|---|
| * | K864831 | Cobe Centrysystem 145E,160E,175E,190E DialyzersSummary page 1…and Baxter CF25 Dialyzers, which have been previously approved for marketing in the United States. The Cobe Cnetry System 160E was approved under a 510(k) Notification (K864831). The Cuprpohan membranes utilzed in both Haidylena Cuprophan and Hemophan Hollow Fiber Dialyzer and Cobe Centry System 160E Dial… | 1987 |
| * | — | Baxter CF25 Named without a submission number | |
| * | — | Terumo Clirans T175 Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991908 | Idemsa Hemophan Hollow Fiber Dialyzers | 2000 | 0 |
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?
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 | — |
What is it indicated for?
The device submitted in this premarket notification are intended for use whenever a patient is in acute or chronic renal failure and hemodialysis is prepared by a physician. Therefore, use of this device should be only on the direction of a physician who has evaluated all of the aspects of the patient’s illness.
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/K982337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982337: Cuprophan and Hemophan Hollow Fiber Dialyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982337
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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