510(k) · Cleared

Cleared

Venous Reservoir W/Cardiotomy Filter

K915573510(k) TraditionalCleared Dec 23, 1992377-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

Baxter Healthcare Corp · DTN Reservoir, Blood, Cardiopulmonary Bypass

Cleared on Dec 23, 1992 after a 377-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 30 devices in its family, counting itself, have a Class I recall. 29 later devices descend from it.

Decided: Dec 23, 1992
Review: 377 days
Class: Class II
Product code: DTN
Recalls: None
Predicates: 0

29 later devices descend from it, 1 citing it directly. 2 of the 30 devices in this family, counting this one, have a Class I recall.

This deviceK915573 Venous Reservoir W/Cardiotomy FilterBaxter Healthcare Corp · 1992
Descendant · cites it directly · 28 of its ownK982223 Capiox SX Hardshell ResevoirTerumo Medical Corp. · 1998
Descendant · 2 generations on · 27 of its ownK991973 Capiox SX10 Hardshell ResevoirTerumo Medical Corp. · 1999
Descendant · 3 generations on · 26 of its ownK030449 Modification to Capiox SX10 Hardshell ReservoirTerumo Corp. · 2003
Descendant · 4 generations on · 25 of its ownK051997 Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell ReservoirTerumo Cardiovascular Systems Corp. · 2005 · Recalled
Descendant · 5 generations on · 9 of its ownK090689 Quadrox-I Small Adult with and Without Intergrated Arterial Filter…Maquet Cardiopulmonary, AG · 2009 · Recalled

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

1998high 4 (2009) · low 0 (2000)2026

Class I recalls in this family

K102726 Cardiohelp System7 generations on · 2011
K133598 Cardiohelp System8 generations on · 2014

Most influential descendants

Showing 5 of 29 · See all

K982223Capiox SX Hardshell ResevoirTerumo Medical Corp. · 1998 · cites it directly28descendants
K991973Capiox SX10 Hardshell ResevoirTerumo Medical Corp. · 1999 · 2 generations on27descendants
K030449Modification to Capiox SX10 Hardshell ReservoirTerumo Corp. · 2003 · 3 generations on26descendants
K051997Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell ReservoirTerumo Cardiovascular Systems Corp. · 2005 · 4 generations on25descendants
K090689Quadrox-I Small Adult with and Without Intergrated Arterial Filter with Softline…Maquet Cardiopulmonary, AG · 2009 · 5 generations on9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K915573	Venous Reservoir W/Cardiotomy Filter	Baxter Healthcare Corp	1992	—
+1	K982223	Capiox SX Hardshell Resevoir	Terumo Medical Corp.	1998	—
+2	K991973	Capiox SX10 Hardshell Resevoir	Terumo Medical Corp.	1999	—
+3	K030449	Modification to Capiox SX10 Hardshell Reservoir	Terumo Corp.	2003	—
+4	K051997	Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell Reservoir	Terumo Cardiovascular Systems Corp.	2005	1
+5	K090689	Quadrox-I Small Adult with and Without Intergrated Arterial Filter with…	Maquet Cardiopulmonary, AG	2009	5

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
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

FIG. 1 — Lineage of K915573, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

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

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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? (29)

See all 29

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K982223	Capiox SX Hardshell Resevoir	Terumo Medical Corp.	1998	28

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 · 7 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 8 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K982223 (Terumo Medical Corp., 1998) has gone furthest, with 28 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	—

https://510kreport.com/device/K915573 · printed Nov 6, 2026

Cite this page

510(k) Report. “K915573: Venous Reservoir W/Cardiotomy Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915573

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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