510(k) · Cleared
ClearedPS 15 Polysulfone Hollow Fiber Membrane Hemodialyzer, Model 239-015
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Althin Medical AB an Affiliate of Baxter Intl · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Dec 7, 1999 as substantially equivalent to K945597 (Althin Medical AB an Affiliate of Baxter Intl, 1995) and 1 other predicate after a 284-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- Dec 7, 1999
- Review
- 284 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K852251 (1985). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK852251 Fresenius Hemoflow F60 & Fresenius Hemoflow F40Seratronics, Inc. · 1985
- This deviceK990643 PS 15 Polysulfone Hollow Fiber Membrane Hemodialyzer, Model 239-015Althin Medical AB an Affiliate of Baxter Intl · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K852251 | Fresenius Hemoflow F60 & Fresenius Hemoflow F40 | Seratronics, Inc. | 1985 | — |
| 0 (this device) | K990643 | PS 15 Polysulfone Hollow Fiber Membrane Hemodialyzer, Model 239-015 | Althin Medical AB an Affiliate of Baxter Intl | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 KDI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KDI device
- #1 K243874 FX CorAL 60 (F00012969); FX CorAL 80…score 18.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K945597 | Altres (R) 170 HemodialyzerSummary page 1…ility Hemodialyzer 21 CFR " 876.5860 lil. Substantially Equivalent Legally Marketed Device: Company Device 510(k) No. | Date Cleared Althin Medical, Inc. | Altrex 170 K945597 | 3/8/95 Hemodialyzer Fresenius Medical Freseniis Fe0 K852251 | 7/25/85 Care Polysulfone Dialyzer 394 Q)\ The PS… | 1995 |
| * | K852251 | Fresenius Hemoflow F60 & Fresenius Hemoflow F40Summary page 1…valent Legally Marketed Device: Company Device 510(k) No. | Date Cleared Althin Medical, Inc. | Altrex 170 K945597 | 3/8/95 Hemodialyzer Fresenius Medical Freseniis Fe0 K852251 | 7/25/85 Care Polysulfone Dialyzer 394 Q)\ The PS 15® Hemodialyzer is substantially equivalent to other predica… | 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?
- None of the 2 ancestors has a recall.
How does its category compare?
All KDI devicesKDI Dialyzer, High Permeability With Or Without Sealed Dialysate System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KDI
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KDI
199in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KDI
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · KDI
2,786in 2025
MAUDE reports naming product code KDI, 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 | 11 | 91 | 4 | 916 |
| 2008 | 6 | 148 | 0 | 1,042 |
| 2009 | 4 | 236 | 3 | 522 |
| 2010 | 9 | 186 | 1 | 823 |
| 2011 | 5 | 85 | 4 | 2,270 |
| 2012 | 6 | 153 | 1 | 1,765 |
| 2013 | 11 | 247 | 2 | 2,360 |
| 2014 | 8 | 164 | 3 | 6,154 |
| 2015 | 5 | 69 | 5 | 4,182 |
| 2016 | 5 | 230 | 4 | 766 |
| 2017 | 8 | 188 | 1 | 963 |
| 2018 | 2 | — | 1 | 1,716 |
| 2019 | 4 | 263 | 6 | 1,587 |
| 2020 | 9 | 266 | 0 | 1,633 |
| 2021 | 2 | — | 2 | 1,944 |
| 2022 | 7 | 259 | 17 | 2,180 |
| 2023 | 7 | 157 | 8 (8) | 2,692 |
| 2024 | 7 | 235 | 4 (2) | 2,441 |
| 2025 | 9 | 199 | 2 | 2,786 |
| 2026 | 6 | 154 | 2 | — |
What is it indicated for?
The PS 15® Hemodialyzer is intended for hemodialysis in patients with acute or chronic renal failure, when conservative therapy is judged to be inadequate.
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/K990643 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990643: PS 15 Polysulfone Hollow Fiber Membrane Hemodialyzer, Model 239-015.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990643
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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