510(k) · Cleared

Cleared

Modification to: CSC14 Blood Cardioplegia System

K012898510(k) SpecialCleared Sep 17, 200119-day reviewClass II21 CFR 870.4240

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

Cobe Cardiovascular, Inc. · DTR Heat-Exchanger, Cardiopulmonary Bypass

Cleared on Sep 17, 2001 as substantially equivalent to K934847 (Sorin Biomedical, Inc., 1994) after a 19-day review. Its family tree reaches back 1 generation to 1994. 6 later devices descend from it.

Decided: Sep 17, 2001
Review: 19 days
Class: Class II
Product code: DTR
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K934847 (1994). 6 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK934847 Ngbcd & Ngbcdp Cardioplegia Delivery SystemsSorin Biomedical, Inc. · 1994 · Recalled
This deviceK012898 Modification to: CSC14 Blood Cardioplegia SystemCobe Cardiovascular, Inc. · 2001
Descendant · cites it directly · 2 of its ownK212688 Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow…Qura S.R.L · 2022
Descendant · cites it directly · 2 of its ownK072583 Plegiox Cardioplegia Heat Exchanger, with Safeline Coating, Model…Maquet Cardiopulmonary, AG · 2008
Descendant · 2 generations on · 1 of its ownK220110 Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow…Qura S.R.L · 2022 · Recalled
Descendant · 2 generations on · 1 of its ownK090555 Plegiox Cardioplegia Heat Exchanger with Softline Coating, Model…Maquet Cardiopulmonary, AG · 2009 · Recalled
Descendant · 3 generations on · 0 of its ownK223879 Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and…Quara S.R.L. · 2023 · Recalled

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2008high 2 (2022) · low 0 (2010)2026

Most influential descendants

Showing 5 of 6 · See all

K212688Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.L · 2022 · cites it directly2descendants
K072583Plegiox Cardioplegia Heat Exchanger, with Safeline Coating, Model (S) CHX30, BSQ-CHX 30Maquet Cardiopulmonary, AG · 2008 · cites it directly2descendants
K220110Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.L · 2022 · 2 generations on1descendant
K090555Plegiox Cardioplegia Heat Exchanger with Softline Coating, Model Bio-CHX 30Maquet Cardiopulmonary, AG · 2009 · 2 generations on1descendant
K223879Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)Quara S.R.L. · 2023 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K934847	Ngbcd & Ngbcdp Cardioplegia Delivery Systems	Sorin Biomedical, Inc.	1994	2
0 (this device)	K012898	Modification to: CSC14 Blood Cardioplegia System	Cobe Cardiovascular, Inc.	2001	—
+1	K212688	Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat…	Qura S.R.L	2022	—
+1	K072583	Plegiox Cardioplegia Heat Exchanger, with Safeline Coating, Model (S) CHX30…	Maquet Cardiopulmonary, AG	2008	—
+2	K220110	Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia…	Qura S.R.L	2022	2
+2	K090555	Plegiox Cardioplegia Heat Exchanger with Softline Coating, Model Bio-CHX 30	Maquet Cardiopulmonary, AG	2009	1
+3	K223879	Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)	Quara S.R.L.	2023	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	1	0
2011	1	0
2022	2	0
2023	1	0

FIG. 1 — Lineage of K012898, 1994–2023Source: 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.

Planning a device in DTR? 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 DTR device

#1 K252541 Quantum PureFlow Standard Heat Exchanger…score 13.4 · 9 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? (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
*	K934847	Ngbcd & Ngbcdp Cardioplegia Delivery Systems Summary page 1 …UAL NAME: Cardioplegia Heat Exchanger CLASSIFICATION NAME: Cardiopulmonary Bypass Blood Heat Exchanger PREDICATE DEVICE: SORIN BCD Vanguard Blood Cardioplegia System, #K934847 DEVICE DESCRIPTION: The CSC14 Blood Cardioplegia System is a sterile device with non-pyrogenic fluid pathways, for single use on…	Sorin Biomedical, Inc.	1994	2

Also cleared against K934847: 3 other devices →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K212688	Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger	Qura S.R.L	2022	2
K072583	Plegiox Cardioplegia Heat Exchanger, with Safeline Coating, Model (S) CHX30, BSQ-CHX 30	Maquet Cardiopulmonary, AG	2008	2

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?

Its one ancestor has a recall.
Of its descendants, K212688 (Qura S.R.L, 2022) has gone furthest, with 2 descendants of its own.
3 other devices also cite its predicate K934847.

How does its category compare?

All DTR devices

DTR Heat-Exchanger, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTR

2in 2025

2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTR

Too few DTR 510(k)s in any year since 2007 to give a median.

Recalls per year · DTR

1in 2015

2007high 24 (2010) · low 0 (2007)2026

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

Adverse event reports per year · DTR

44in 2025

2007high 96 (2015) · low 0 (2009)2025

MAUDE reports naming product code DTR, 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	0	—	0	2
2008	1	—	0	1
2009	2	—	0	0
2010	0	—	24	43
2011	0	—	3	67
2012	0	—	0	16
2013	0	—	0	27
2014	0	—	0	66
2015	0	—	1	96
2016	0	—	0	60
2017	2	—	0	69
2018	1	—	0	75
2019	0	—	0	35
2020	2	—	0	33
2021	0	—	0	11
2022	2	—	0	23
2023	1	—	0	18
2024	1	—	0	8
2025	2	—	0	44
2026	1	—	2	—

What is it indicated for?

The CSC14 Blood Cardioplegia System is intended to mix, cool, warm, and deliver oxygenated blood and cardioplegic solution for periods of up to six hours. The device also allows monitoring of temperature and pressure, traps bubbles, and allows for air removal. Blood and cardioplegic solution are delivered to the patient by a 100% occlusive roller pump through the extension line and appropriate cannula.

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/K012898 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012898: Modification to: CSC14 Blood Cardioplegia System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012898

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026