510(k) · Cleared

Cleared

Capiox Cardioplegia

K982467510(k) TraditionalCleared Jun 23, 1999343-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

Terumo Medical Corp. · DTR Heat-Exchanger, Cardiopulmonary Bypass

Cleared on Jun 23, 1999 as substantially equivalent to K934847 (Sorin Biomedical, Inc., 1994) and 1 other predicate after a 343-day review. Its family tree reaches back 1 generation to 1992.

Decided: Jun 23, 1999
Review: 343 days
Class: Class II
Product code: DTR
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K923311 (1992). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK923311 Conducer Heat Exchanger3M Health Care, Sarns · 1992
This deviceK982467 Capiox CardioplegiaTerumo Medical Corp. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K923311	Conducer Heat Exchanger	3M Health Care, Sarns	1992	—
0 (this device)	K982467	Capiox Cardioplegia	Terumo Medical Corp.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

FIG. 1 — Lineage of K982467, 1992–1999Source: 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? (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	Applicant	Decided	Recalls
*	K934847	Ngbcd & Ngbcdp Cardioplegia Delivery Systems Summary page 1 …tially equivalent to Sorin BCD Vanguard and the Sarns Conducer. The discussion and table below compare the CAPIOX® Cardioplegia with the Sorin BCD Vanguard cleared under K934847 and the Sarns Conducer (K923311). />a7: ofs II - Summary and Certification Summary of Safety and Effectiveness…	Sorin Biomedical, Inc.	1994	2
*	K923311	Conducer Heat Exchanger Summary page 1 …anguard and the Sarns Conducer. The discussion and table below compare the CAPIOX® Cardioplegia with the Sorin BCD Vanguard cleared under K934847 and the Sarns Conducer (K923311). />a7: ofs II - Summary and Certification Summary of Safety and Effectiveness Intended Use All the devices are…	3M Health Care, Sarns	1992	—

Also cleared against K934847: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

1 of the 2 ancestors has a recall of any class.
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 CAPIOX Cardioplegia is cardiopulmonary bypass heat exchanger consisting

of a heat exchange system used in extracorporeal circulation to warm or cool the

blood or perfusion fluid flowing through the device for periods up to 6 hours.

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/K982467 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982467: Capiox Cardioplegia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982467

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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