510(k) · Cleared

Cleared

Modification to Capiox SX10 Hardshell Reservoir

K030449510(k) SpecialCleared Mar 5, 200322-day reviewClass II21 CFR 870.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Terumo Corp. · DTN Reservoir, Blood, Cardiopulmonary Bypass

Cleared on Mar 5, 2003 as substantially equivalent to K991973 (Terumo Medical Corp., 1999) after a 22-day review. Its family tree reaches back 3 generations to 1992. 2 of the 31 devices in its family, counting itself, have a Class I recall. 26 later devices descend from it.

Decided: Mar 5, 2003
Review: 22 days
Class: Class II
Product code: DTN
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K915573 (1992). 4 ancestors in all. 26 later devices descend from it, 2 citing it directly. 2 of the 31 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 3 generations backK915573 Venous Reservoir W/Cardiotomy FilterBaxter Healthcare Corp · 1992
2 generations backK982223 Capiox SX Hardshell ResevoirTerumo Medical Corp. · 1998
1 generation backK991973 Capiox SX10 Hardshell ResevoirTerumo Medical Corp. · 1999
This deviceK030449 Modification to Capiox SX10 Hardshell ReservoirTerumo Corp. · 2003
Descendant · cites it directly · 25 of its ownK051997 Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell ReservoirTerumo Cardiovascular Systems Corp. · 2005 · Recalled
Descendant · 2 generations on · 9 of its ownK090689 Quadrox-I Small Adult with and Without Intergrated Arterial Filter…Maquet Cardiopulmonary, AG · 2009 · Recalled
Descendant · cites it directly · 9 of its ownK062381 Capiox RX Oxygenator with or Without ReservoirTerumo Cardiovascular Systems Corp. · 2006 · Recalled
Descendant · 3 generations on · 8 of its ownK093522 Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline…Maquet Cardiopulmonary, AG · 2009 · Recalled
Descendant · 2 generations on · 7 of its ownK130333 Capix RX Hollow Fiber Oxygenator with/Without Hardshell ReservoirTerumo Cardiovascular Systems Corp. · 2013

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2005high 4 (2009) · low 0 (2008)2026

Class I recalls in this family

K102726 Cardiohelp System4 generations on · 2011
K133598 Cardiohelp System5 generations on · 2014

Most influential descendants

Showing 5 of 26 · See all

K051997Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell ReservoirTerumo Cardiovascular Systems Corp. · 2005 · cites it directly25descendants
K090689Quadrox-I Small Adult with and Without Intergrated Arterial Filter with Softline…Maquet Cardiopulmonary, AG · 2009 · 2 generations on9descendants
K062381Capiox RX Oxygenator with or Without ReservoirTerumo Cardiovascular Systems Corp. · 2006 · cites it directly9descendants
K093522Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and W/…Maquet Cardiopulmonary, AG · 2009 · 3 generations on8descendants
K130333Capix RX Hollow Fiber Oxygenator with/Without Hardshell ReservoirTerumo Cardiovascular Systems Corp. · 2013 · 2 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K915573	Venous Reservoir W/Cardiotomy Filter	Baxter Healthcare Corp	1992	—
−2	K982223	Capiox SX Hardshell Resevoir	Terumo Medical Corp.	1998	—
−1	K991973	Capiox SX10 Hardshell Resevoir	Terumo Medical Corp.	1999	—
0 (this device)	K030449	Modification to Capiox SX10 Hardshell Reservoir	Terumo Corp.	2003	—
+1	K051997	Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell Reservoir	Terumo Cardiovascular Systems Corp.	2005	1
+2	K090689	Quadrox-I Small Adult with and Without Intergrated Arterial Filter with…	Maquet Cardiopulmonary, AG	2009	5
+1	K062381	Capiox RX Oxygenator with or Without Reservoir	Terumo Cardiovascular Systems Corp.	2006	2
+3	K093522	Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and…	Maquet Cardiopulmonary, AG	2009	3
+2	K130333	Capix RX Hollow Fiber Oxygenator with/Without Hardshell Reservoir	Terumo Cardiovascular Systems Corp.	2013	—

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
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

FIG. 1 — Lineage of K030449, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 12.4 · 7 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) 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	Applicant	Decided	Recalls
*	K991973	Capiox SX10 Hardshell Resevoir Summary page 1 …als, design, technology and principles of operation, and performance to the CAPIOXB SX 10 Hardshell Reservoir that was cleared for marketing under Premarket Notification K99 1973. Intended Use: The CAPIOXO SXlO Hardshell Reservoir is a hardshell reservoir used to store blood during extra-corporeal circulat…	Terumo Medical Corp.	1999	—

What descends from it? (26)

See all 26

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K051997	Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell Reservoir	Terumo Cardiovascular Systems Corp.	2005	25
K062381	Capiox RX Oxygenator with or Without Reservoir	Terumo Cardiovascular Systems Corp.	2006	9

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.

K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
None of the 4 ancestors has a recall.
Of its descendants, K051997 (Terumo Cardiovascular Systems Corp., 2005) has gone furthest, with 25 descendants of its own.

How does its category compare?

All DTN devices

DTN Reservoir, Blood, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTN

1in 2025

2007high 7 (2009) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTN

38in 2014

2007high 211 (2009) · low 38 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DTN

2in 2018

2007high 2 (2018) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DTN

8in 2025

2007high 52 (2014) · low 3 (2017)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 CAPIOXB SXlO Hardshell Reservoir is a hardshell reservoir used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line during cardiopulmonary bypass procedures lasting up to 6 hours. The reservoir contains filters to remove particulate matter and defoamers to facilitate air bubble removal.

The Hardshell Reservoir may also be used with vacuum-assisted venous return procedures during cardiopulmonary bypass procedures lasting up to 6 hours.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030449 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030449: Modification to Capiox SX10 Hardshell Reservoir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030449

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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