510(k) · Cleared
ClearedCapiox Hemoconcentrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Medical Corp. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Jan 30, 1998 as substantially equivalent to K923139 (Minntech Corp., 1994) after a 135-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it.
- Decided
- Jan 30, 1998
- Review
- 135 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923139 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK923139 Hemocor HP Hemoconcentrator SeriesMinntech Corp. · 1994 · Recalled
- This deviceK973516 Capiox HemoconcentratorTerumo Medical Corp. · 1998
- Descendant · cites it directly · 0 of its ownK243920 Purema H Hemoconcentrator - PediatricMedica USA, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK232171 Purema® H Hemoconcentrator (EtO Sterilized)Tecnoideal America · 2024
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 | K923139 | Hemocor HP Hemoconcentrator Series | Minntech Corp. | 1994 | 1 |
| 0 (this device) | K973516 | Capiox Hemoconcentrator | Terumo Medical Corp. | 1998 | — |
| +1 | K243920 | Purema H Hemoconcentrator - Pediatric | Medica USA, Inc. | 2025 | — |
| +1 | K232171 | Purema® H Hemoconcentrator (EtO Sterilized) | Tecnoideal America | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K923139 | Hemocor HP Hemoconcentrator SeriesSummary page 2…riming with blood is acceptable. Substantial Equivalence The CAPIOX® Hemoconcentrator is substantially equivalent to the Minntech Hemocor HPH Hemonconcentrator (510(k) K923139).as follows: Intended use: same Design and Materials Both devices consist of a tubular casing which contains glycerine-free poly… | 1994 |
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 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 CAPIOX Hemoconcentrator is designed to remove excess fluid from the blood in order to maintain proper hematocrit and protein concentration during cardiopulmonary bypass and to enable reinfusion of blood remaining in the circuit after bypass.
It is intended to be used during and after surgical procedures requiring cardiopulmonary bypass (up to 6 hours) when the removal of excess fluid from blood is required. It should not be used as a dialyzer, hemofilter or other device.
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/K973516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973516: Capiox Hemoconcentrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973516
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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