510(k) · Cleared
ClearedPSN Dialyzer, Model PSN 130/R5M4233, Model PSN-150/R5M4234
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · FJI Dialyzer, Capillary, Hollow Fiber
Cleared on May 19, 1998 after an 89-day review. The FDA summary names its predicate without a number.
- Decided
- May 19, 1998
- Review
- 89 days
- Class
- Class II
- Product code
- FJI
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (2)
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 |
|---|---|---|---|
| * | — | CA® Hollow Fiber Dialyzers Named without a submission number | |
| * | — | Baxter predicate Dialyzers Named without a submission number |
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.
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?
Hemodialysis with these dialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It may also be indicated in the treatment of patients intoxicated with poisons or drugs.
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/K980658 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980658: PSN Dialyzer, Model PSN 130/R5M4233, Model PSN-150/R5M4234.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980658
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026