510(k) · Cleared
ClearedDynamic Hollow Fiber Dialyzer DC-Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dynamic Technology Corp. · FJI Dialyzer, Capillary, Hollow Fiber
Cleared on Dec 19, 1997 as substantially equivalent to K864831 (Cobe Laboratories, Inc., 1987) after a 108-day review. Its family tree reaches back 1 generation to 1987. 2 later devices descend from it.
- Decided
- Dec 19, 1997
- Review
- 108 days
- Class
- Class II
- Product code
- FJI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K864831 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK864831 Cobe Centrysystem 145E,160E,175E,190E DialyzersCobe Laboratories, Inc. · 1987
- This deviceK973291 Dynamic Hollow Fiber Dialyzer DC-SeriesDynamic Technology Corp. · 1997
- Descendant · cites it directly · 0 of its ownK990159 Dynamic Hollow Fiber Dialyzer DH-Series, Model AH 90111Dynamic Technology Corp. · 1999
- Descendant · cites it directly · 0 of its ownK982134 Dynamic Hollow Fiber Dialyzer DS-Series Model as-851Dynamic Technology Corp. · 1999
Most influential descendants
Showing 2 of 2 · See allView 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) | K973291 | Dynamic Hollow Fiber Dialyzer DC-Series | Dynamic Technology Corp. | 1997 | — |
| +1 | K990159 | Dynamic Hollow Fiber Dialyzer DH-Series, Model AH 90111 | Dynamic Technology Corp. | 1999 | — |
| +1 | K982134 | Dynamic Hollow Fiber Dialyzer DS-Series Model as-851 | Dynamic Technology Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 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? (4)
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…tantially equivalent to the membranes utilized in the Cobhe CentrySystem 160E and Baxter CF25 Dialyzers, which have been previously approved under a 510(k) Notification (K864831). Blood enters a blood inlet port where it is distributed to hollow fibers. Each hollow fiber has an inner diameter of 200 micro… | 1987 |
| * | — | Baxter CF25 Named without a submission number | |
| * | — | Terumo Clirans T175 Named without a submission number | |
| * | — | Terumo Clirans T174 Named without a submission number |
What descends from it? (2)
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?
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 DYNAMIC Hollow Fiber Dialyzer DC-Series are indicated for use whenever a patient is in acute or chronic renal failure and hemodialysis is prescribed 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/K973291 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973291: Dynamic Hollow Fiber Dialyzer DC-Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973291
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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