510(k) · Cleared
ClearedClirans T-Series Hollow Fiber Dialyzers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Medical Corp. · FJI Dialyzer, Capillary, Hollow Fiber
Cleared on Dec 19, 1997 as substantially equivalent to K854280 (Terumo Medical Corp., 1985) after a 296-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- Dec 19, 1997
- Review
- 296 days
- Class
- Class II
- Product code
- FJI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K854280 (1985). No later device cites it as a predicate yet.
- Root · 1 generation backK854280 Clirans Taf Hollow Fiber DialyzerTerumo Medical Corp. · 1985
- This deviceK970708 Clirans T-Series Hollow Fiber DialyzersTerumo Medical Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K854280 | Clirans Taf Hollow Fiber Dialyzer | Terumo Medical Corp. | 1985 | — |
| 0 (this device) | K970708 | Clirans T-Series Hollow Fiber Dialyzers | Terumo Medical Corp. | 1997 | — |
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? (1)
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 |
|---|---|---|---|
| * | K854280 | Clirans Taf Hollow Fiber DialyzerSummary page 1…ogy/principles of operation, materials and performance to the largest effective surface area dialyzer (CL*M151L) cleared in the CLIRANS® TAF Hollow Fiber Dialyzer 510(k) K854280. 009 SECTION II: Summary and Certification PRINCIPLE OF OPERATION/TECHNOLOGY The CLIRANS® T-Series Hollow Fibe… | 1985 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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 CLIRANS® T-Series Hollow Fiber Dialyzers are devices used as part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. This device is indicated for single and multiple use.
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/K970708 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970708: Clirans T-Series Hollow Fiber Dialyzers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970708
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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