510(k) · Cleared

Cleared

Cardiovention Corx System, Model FG 0001

K012325510(k) TraditionalCleared Apr 9, 2002260-day reviewClass II21 CFR 870.4360

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

Cardiovention, Inc. · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Cleared on Apr 9, 2002 after a 260-day review. The FDA summary names its predicate without a number. 2 of the 16 devices in its family, counting itself, have a Class I recall. 15 later devices descend from it.

Decided: Apr 9, 2002
Review: 260 days
Class: Class II
Product code: KFM
Recalls: None
Predicates: 0

15 later devices descend from it, 2 citing it directly. 2 of the 16 devices in this family, counting this one, have a Class I recall.

This deviceK012325 Cardiovention Corx System, Model FG 0001Cardiovention, Inc. · 2002
Descendant · cites it directly · 13 of its ownK031700 Medtronic Resting Heart System, Model AAR1000 and 711Medtronic Perfusion Systems · 2003 · Recalled
Descendant · 2 generations on · 5 of its ownK111972 Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm…Medtronic, Inc. · 2011
Descendant · 2 generations on · 5 of its ownK090006 Lifebridge B2T, Model 7001Lifebridge Medizintechnik AG · 2009
Descendant · 3 generations on · 4 of its ownK120988 DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous…Medtronic, Inc. · 2012 · Recalled
Descendant · 4 generations on · 2 of its ownK140165 MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula…Medtronic, Inc. · 2014

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2003high 3 (2011) · low 0 (2004)2026

Class I recalls in this family

K102726 Cardiohelp System3 generations on · 2011
K133598 Cardiohelp System4 generations on · 2014

Most influential descendants

Showing 5 of 15 · See all

K031700Medtronic Resting Heart System, Model AAR1000 and 711Medtronic Perfusion Systems · 2003 · cites it directly13descendants
K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc. · 2011 · 2 generations on5descendants
K090006Lifebridge B2T, Model 7001Lifebridge Medizintechnik AG · 2009 · 2 generations on5descendants
K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc. · 2012 · 3 generations on4descendants
K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage…Medtronic, Inc. · 2014 · 4 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K012325	Cardiovention Corx System, Model FG 0001	Cardiovention, Inc.	2002	—
+1	K031700	Medtronic Resting Heart System, Model AAR1000 and 711	Medtronic Perfusion Systems	2003	1
+2	K111972	Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia…	Medtronic, Inc.	2011	—
+2	K090006	Lifebridge B2T, Model 7001	Lifebridge Medizintechnik AG	2009	—
+3	K120988	DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula…	Medtronic, Inc.	2012	2
+4	K140165	MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall…	Medtronic, Inc.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2009	2	0
2010	1	0
2011	3	1
2012	1	0
2013	1	0
2014	2	1
2025	1	0
2026	2	0

FIG. 1 — Lineage of K012325, 2002–2026Source: 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 KFM device

#1 K250326 Quantum Perfusion Centrifugal Blood Pump…score 11.4 · 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? (3)

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	Recalls
*	—	Optimin Hollow Fiber Oxygenator Named without a submission number	—
*	—	Sarns Delphin Centrifugal Blood Pump Named without a submission number	—
*	—	HVR2200 Hard Shell Venous Reservoir (defoamer) Named without a submission number	—

What descends from it? (15)

See all 15

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

Number	Device	Applicant	Decided	Descendants
K031700	Medtronic Resting Heart System, Model AAR1000 and 711	Medtronic Perfusion Systems	2003	13
K030141	Modification to Cardiovention Powerbase Console, Model PCB-100	Cardiovention, Inc.	2003	0

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

What does this lineage say?

Of its descendants, K031700 (Medtronic Perfusion Systems, 2003) has gone furthest, with 13 descendants of its own.

How does its category compare?

All KFM devices

KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KFM

2in 2025

2007high 7 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KFM

30in 2023

2007high 534 (2021) · low 16 (2011)2026

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

Recalls per year · KFM

2in 2024

2007high 5 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · KFM

249in 2025

2007high 446 (2021) · low 57 (2011)2025

MAUDE reports naming product code KFM, 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	60
2008	4	194	2	62
2009	5	184	4	85
2010	3	109	2	81
2011	7	16	1	57
2012	0	—	5	82
2013	2	—	0	104
2014	0	—	0	347
2015	0	—	0	299
2016	0	—	0	156
2017	1	—	0	121
2018	0	—	1	176
2019	3	147	3 (1)	311
2020	3	30	0	437
2021	3	534	0	446
2022	0	—	0	294
2023	3	30	0	346
2024	0	—	2	296
2025	2	—	0	249
2026	0	—	0	—

What is it indicated for?

The CardioVention CORx System is intended to be used in surgical procedures requiring extracorporeal gas exchange support. This device can be used with a legally marketed thermal regulating system. The device is indicated for use in procedures requiring a maximum blood flow rate of six liters/minute and lasting up to six hours.

The CORXx System is intended for use with the Medtronic Bio-medicus Bio-Console.

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/K012325 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012325: Cardiovention Corx System, Model FG 0001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012325

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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