510(k) · Cleared
ClearedCapiox SX Hardshell Resevoir
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Medical Corp. · DTN Reservoir, Blood, Cardiopulmonary Bypass
Cleared on Sep 10, 1998 as substantially equivalent to K915573 (Baxter Healthcare Corp, 1992) and 1 other predicate after a 78-day review. Its family tree reaches back 1 generation to 1992. 2 of the 31 devices in its family, counting itself, have a Class I recall. 28 later devices descend from it.
- Decided
- Sep 10, 1998
- Review
- 78 days
- Class
- Class II
- Product code
- DTN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K915573 (1992). 2 ancestors in all. 28 later devices descend from it, 1 citing it directly. 2 of the 31 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK915573 Venous Reservoir W/Cardiotomy FilterBaxter Healthcare Corp · 1992
- This deviceK982223 Capiox SX Hardshell ResevoirTerumo Medical Corp. · 1998
- Descendant · cites it directly · 27 of its ownK991973 Capiox SX10 Hardshell ResevoirTerumo Medical Corp. · 1999
- Descendant · 2 generations on · 26 of its ownK030449 Modification to Capiox SX10 Hardshell ReservoirTerumo Corp. · 2003
- Descendant · 3 generations on · 25 of its ownK051997 Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell ReservoirTerumo Cardiovascular Systems Corp. · 2005 · Recalled
- Descendant · 4 generations on · 9 of its ownK090689 Quadrox-I Small Adult with and Without Intergrated Arterial Filter…Maquet Cardiopulmonary, AG · 2009 · Recalled
- Descendant · 3 generations on · 9 of its ownK062381 Capiox RX Oxygenator with or Without ReservoirTerumo Cardiovascular Systems Corp. · 2006 · Recalled
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 28 · See all- K991973Capiox SX10 Hardshell ResevoirTerumo Medical Corp. · 1999 · cites it directly27descendants
- K030449Modification to Capiox SX10 Hardshell ReservoirTerumo Corp. · 2003 · 2 generations on26descendants
- K051997Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell ReservoirTerumo Cardiovascular Systems Corp. · 2005 · 3 generations on25descendants
- K090689Quadrox-I Small Adult with and Without Intergrated Arterial Filter with Softline…Maquet Cardiopulmonary, AG · 2009 · 4 generations on9descendants
- K062381Capiox RX Oxygenator with or Without ReservoirTerumo Cardiovascular Systems Corp. · 2006 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915573 | Venous Reservoir W/Cardiotomy Filter | Baxter Healthcare Corp | 1992 | — |
| 0 (this device) | K982223 | Capiox SX Hardshell Resevoir | Terumo Medical Corp. | 1998 | — |
| +1 | K991973 | Capiox SX10 Hardshell Resevoir | Terumo Medical Corp. | 1999 | — |
| +2 | K030449 | Modification to Capiox SX10 Hardshell Reservoir | Terumo Corp. | 2003 | — |
| +3 | K051997 | Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell Reservoir | Terumo Cardiovascular Systems Corp. | 2005 | 1 |
| +4 | K090689 | Quadrox-I Small Adult with and Without Intergrated Arterial Filter with… | Maquet Cardiopulmonary, AG | 2009 | 5 |
| +3 | K062381 | Capiox RX Oxygenator with or Without Reservoir | Terumo Cardiovascular Systems Corp. | 2006 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 4 | 0 |
| 2011 | 2 | 1 |
| 2013 | 4 | 0 |
| 2014 | 3 | 1 |
| 2015 | 4 | 0 |
| 2018 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
2 devices in this family have a Class I recall. 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 DTN device
- #1 K251783 Inspire HCR and HCR DUAL cardiotomy reservoirsscore 12.3 · 7 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 |
|---|---|---|---|
| * | K915573 | Venous Reservoir W/Cardiotomy FilterSummary page 2…mmary and Certification Summary of Safety and Effectiveness Substantial Equivalence The CAPIOX® SX Reservoir is substantially equivalent to the Baxter Bentley HSR4000 (K915573) and Bentley BMR Venous Reservoir (K971455) # as follows: Intended use: same as described on previous page. Design These devic… | 1992 |
| * | K974155 | BMR 4500 Filtered Venous Reservoir and BMR -4500 Gold Filtered Venous Reservoir with… Our OCR of the scanned summary read K971455, FDA’s number for Clarus Model 5197 Sightlite (Clarus Medical Systems, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Bentley BMR Venous Reservoir”. | 1998 |
What descends from it? (28)
See all 281 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991973 | Capiox SX10 Hardshell Resevoir | 1999 | 27 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K991973 (Terumo Medical Corp., 1999) has gone furthest, with 27 descendants of its own.
How does its category compare?
All DTN devicesDTN Reservoir, Blood, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DTN
38in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTN
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTN
8in 2025
MAUDE reports naming product code DTN, 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 | 2 | — | 1 | 10 |
| 2008 | 1 | — | 1 | 8 |
| 2009 | 7 | 211 | 1 | 10 |
| 2010 | 1 | — | 0 | 18 |
| 2011 | 2 | — | 1 | 10 |
| 2012 | 0 | — | 0 | 17 |
| 2013 | 4 | 79 | 0 | 47 |
| 2014 | 3 | 38 | 0 | 52 |
| 2015 | 2 | — | 0 | 27 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 2 | — | 1 | 3 |
| 2018 | 0 | — | 2 | 4 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 2 | — | 0 | 10 |
| 2025 | 1 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CAPIOX SX Hardshell Reservoir is a hardshell reservoir used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains filters to remove particulate matter and defoamers to facilitate air bubble removal.
The Hardshell Reservoir is also used for post-operative chest drainage and autotransfusion procedures to aseptically return the blood to the patient for blood volume replacement
The Hardshell Reservoir is also used with the vacuum-assisted venous return technique during cardiopulmonary bypass.
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/K982223 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982223: Capiox SX Hardshell Resevoir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982223
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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