510(k) · Cleared
ClearedAF-220 Hemodialyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Althin Medical AB · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Jan 18, 2000 as substantially equivalent to K926373 (Althin Medical AB an Affiliate of Baxter Intl, 1995) after a 169-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- Jan 18, 2000
- Review
- 169 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K926373 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK926373 Altra Flux 200 HemodialyzerAlthin Medical AB an Affiliate of Baxter Intl · 1995
- This deviceK992573 AF-220 HemodialyzerAlthin Medical AB · 2000
- Descendant · cites it directly · 1 of its ownK013550 Clirans E-Series DialyzerTerumo Medical Corp. · 2001
- Descendant · 2 generations on · 0 of its ownK162248 Asahi ViE-U Series DialyzerAsahi Kasei Medical Co., Ltd. · 2017
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 | K926373 | Altra Flux 200 Hemodialyzer | Althin Medical AB an Affiliate of Baxter Intl | 1995 | — |
| 0 (this device) | K992573 | AF-220 Hemodialyzer | Althin Medical AB | 2000 | — |
| +1 | K013550 | Clirans E-Series Dialyzer | Terumo Medical Corp. | 2001 | — |
| +2 | K162248 | Asahi ViE-U Series Dialyzer | Asahi Kasei Medical Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2017 | 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? (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 |
|---|---|---|---|
| * | K926373 | Altra Flux 200 HemodialyzerSummary page 1…ermeability dialyzer per 21 CFR §867.5860 Substantially Equivalent legally marketed device: Company Device 510(k) number Date cleared Althin Medical Inc Altra Flux 200 K926373 02/13/95 Hemodialyzer The AF-220 Hemodialyzer is substantially equivalent to other predicate devices currently in commercial dis… | 1995 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013550 | Clirans E-Series Dialyzer | 2001 | 1 |
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 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?
Hemodialysis with Althin capillary dialyzers are indicated for 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/K992573 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992573: AF-220 Hemodialyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992573
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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