510(k) · Cleared
ClearedCapiox SX Hollow Fiber Oxygenator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Medical Corp. · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on Sep 2, 1993 after a 449-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Sep 2, 1993
- Review
- 449 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK922799 Capiox SX Hollow Fiber OxygenatorTerumo Medical Corp. · 1993
- Descendant · cites it directly · 3 of its ownK964973 Gish Cap VRF45 Cardiotomy/Venous ReservoirGish Biomedical, Inc. · 1997
- Descendant · 2 generations on · 1 of its ownK030726 Gish CAPVRF44 Hardshell Venous Reservoir with GBS CoatingGish Biomedical, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK961836 Maxima Forte Hardshell Venous ReservoirMedtronic Vascular · 1996
- Descendant · 2 generations on · 0 of its ownK083131 Medos Hilite Reservoir, Model: 4030Gish Biomedical, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK081947 Gish CAPVRF44 Hardshell Venous Reservoir with HA CoatingGish Biomedical, Inc. · 2009
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K964973Gish Cap VRF45 Cardiotomy/Venous ReservoirGish Biomedical, Inc. · 1997 · cites it directly3descendants
- K030726Gish CAPVRF44 Hardshell Venous Reservoir with GBS CoatingGish Biomedical, Inc. · 2003 · 2 generations on1descendant
- K961836Maxima Forte Hardshell Venous ReservoirMedtronic Vascular · 1996 · cites it directly1descendant
- K083131Medos Hilite Reservoir, Model: 4030Gish Biomedical, Inc. · 2009 · 2 generations on0descendants
- K081947Gish CAPVRF44 Hardshell Venous Reservoir with HA CoatingGish Biomedical, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K922799 | Capiox SX Hollow Fiber Oxygenator | Terumo Medical Corp. | 1993 | — |
| +1 | K964973 | Gish Cap VRF45 Cardiotomy/Venous Reservoir | Gish Biomedical, Inc. | 1997 | — |
| +2 | K030726 | Gish CAPVRF44 Hardshell Venous Reservoir with GBS Coating | Gish Biomedical, Inc. | 2003 | — |
| +1 | K961836 | Maxima Forte Hardshell Venous Reservoir | Medtronic Vascular | 1996 | — |
| +2 | K083131 | Medos Hilite Reservoir, Model: 4030 | Gish Biomedical, Inc. | 2009 | — |
| +2 | K081947 | Gish CAPVRF44 Hardshell Venous Reservoir with HA Coating | Gish Biomedical, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2009 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DTZ? 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 DTZ device
- #1 K240934 Quantum Perfusion Blood Oxygenator ECC…score 14.3 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
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?
- Of its descendants, K964973 (Gish Biomedical, Inc., 1997) has gone furthest, with 3 descendants of its own.
How does its category compare?
All DTZ devicesDTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DTZ
124in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTZ
1in 2025
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · DTZ
976in 2025
MAUDE reports naming product code DTZ, 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 | 4 | 55 | 7 | 134 |
| 2008 | 3 | 88 | 5 | 105 |
| 2009 | 9 | 210 | 0 | 52 |
| 2010 | 2 | — | 1 | 119 |
| 2011 | 4 | 160 | 13 | 190 |
| 2012 | 9 | 90 | 14 | 215 |
| 2013 | 9 | 28 | 0 | 346 |
| 2014 | 5 | 28 | 2 | 764 |
| 2015 | 9 | 134 | 0 | 658 |
| 2016 | 3 | 62 | 1 | 443 |
| 2017 | 2 | — | 0 | 388 |
| 2018 | 3 | 72 | 2 (2) | 320 |
| 2019 | 5 | 90 | 1 | 489 |
| 2020 | 5 | 93 | 3 | 442 |
| 2021 | 5 | 336 | 1 (1) | 595 |
| 2022 | 2 | — | 6 | 559 |
| 2023 | 5 | 145 | 0 | 738 |
| 2024 | 3 | 124 | 0 | 535 |
| 2025 | 2 | — | 1 | 976 |
| 2026 | 3 | 137 | 0 | — |
https://510kreport.com/device/K922799 · printed Nov 6, 2026
Cite this page
510(k) Report. “K922799: Capiox SX Hollow Fiber Oxygenator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922799
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026