510(k) · Cleared

Recalled · 2008

Medtronic Resting Heart System, Model AAR1000 and 711

K031700510(k) TraditionalCleared Aug 29, 200388-day reviewClass II21 CFR 870.4400Recalls 1

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

Medtronic Perfusion Systems · DTN Reservoir, Blood, Cardiopulmonary Bypass

Cleared on Aug 29, 2003 as substantially equivalent to K935717 (Avecor Cardiovascular, Inc., 1994) and 3 other predicates after an 88-day review. Its family tree reaches back 1 generation to 1989. 2 of the 18 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it. It has been recalled once.

Decided: Aug 29, 2003
Review: 88 days
Class: Class II
Product code: DTN
Recalls: 1
Predicates: 4

Its longest line of descent runs back 1 generation to K891687 (1989). 4 ancestors in all. 13 later devices descend from it, 3 citing it directly. 2 of the 18 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK891687 Extracorporeal Circuit with Bio-Active SurfaceMedtronic Blood Systems, Inc. · 1989 · Recalled
This deviceK031700 Medtronic Resting Heart System, Model AAR1000 and 711Medtronic Perfusion Systems · 2003
Descendant · cites it directly · 5 of its ownK111972 Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm…Medtronic, Inc. · 2011
Descendant · cites it directly · 5 of its ownK090006 Lifebridge B2T, Model 7001Lifebridge Medizintechnik AG · 2009
Descendant · 2 generations on · 4 of its ownK120988 DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous…Medtronic, Inc. · 2012 · Recalled
Descendant · 3 generations on · 2 of its ownK140165 MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula…Medtronic, Inc. · 2014
Descendant · 2 generations on · 2 of its ownK102726 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · Recalled (Class I)

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2009high 3 (2011) · low 0 (2015)2026

Class I recalls in this family

K102726 Cardiohelp System2 generations on · 2011
K133598 Cardiohelp System3 generations on · 2014

Most influential descendants

Showing 5 of 13 · See all

K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc. · 2011 · cites it directly5descendants
K090006Lifebridge B2T, Model 7001Lifebridge Medizintechnik AG · 2009 · cites it directly5descendants
K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc. · 2012 · 2 generations on4descendants
K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage…Medtronic, Inc. · 2014 · 3 generations on2descendants
K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K891687	Extracorporeal Circuit with Bio-Active Surface	Medtronic Blood Systems, Inc.	1989	10
0 (this device)	K031700	Medtronic Resting Heart System, Model AAR1000 and 711	Medtronic Perfusion Systems	2003	—
+1	K111972	Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia…	Medtronic, Inc.	2011	—
+1	K090006	Lifebridge B2T, Model 7001	Lifebridge Medizintechnik AG	2009	—
+2	K120988	DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula…	Medtronic, Inc.	2012	2
+3	K140165	MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall…	Medtronic, Inc.	2014	—
+2	K102726	Cardiohelp System	Maquet Cardiopulmonary, AG	2011	Class I

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1996	1	0
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
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 K031700, 1989–2026Source: 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? (4)

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
*	K935717	Affinity Venous Reservior Bag Summary page 2 …onic Resting Heart System 5 10(k) Submission Predicate Devices(For newkhanged components): 1. AFFINITY@ Venous Reservoir Bag (K935717) 2. CarmedaThlCoated Tubings and Connectors (K89 1687) 3. M…	Avecor Cardiovascular, Inc.	1994	—
*	K891687	Extracorporeal Circuit with Bio-Active Surface Summary page 2 …mponents): 1. AFFINITY@ Venous Reservoir Bag (K935717) 2. CarmedaThlCoated Tubings and Connectors (K89 1687) 3. Medtronic OverpressureNacuum Relief Valve (K953564)…	Medtronic Blood Systems, Inc.	1989	10
*	K953564	Medtronic Overpressure/Vacuum Relief Valve Summary page 2 …CarmedaThlCoated Tubings and Connectors (K89 1687) 3. Medtronic OverpressureNacuum Relief Valve (K953564) 4. CardioVentions CORx System (KO12325) Device Description: The Medtronic Res…	Medtronic Cardiac Surgery, Medtronic, Inc.	1996	—
*	K012325	Cardiovention Corx System, Model FG 0001	Cardiovention, Inc.	2002	—

Also cleared against K935717: 1 other device →

What descends from it? (13)

See all 13

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

Number	Device	Applicant	Decided	Descendants
K111972	Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…	Medtronic, Inc.	2011	5
K090006	Lifebridge B2T, Model 7001	Lifebridge Medizintechnik AG	2009	5
K082321	Terumo Rocsafe Hybrid Perfusion System	Terumo Cardiovascular Systems Corp.	2009	0

Has anything in its family been recalled? (2 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 9, 2008	Not classified	Z-1919-2008	Nonconforming Material/Component	Medtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with contaminated heparin. Medtronic's heparin supplier recently…

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

What does this lineage say?

1 of the 4 ancestors has a recall of any class.
Of its descendants, K111972 (Medtronic, Inc., 2011) has gone furthest, with 5 descendants of its own.
1 other device also cites its predicate K935717.

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 Medtronic Resting Heart System is intended for use in surgical procedures requiring extracorporeal gas exchange, circulatory support, and thermal regulation. This device is indicated for use in procedures requiring blood flow rate of 1 to 6 liters/min and lasting up to six hours. The system is indicated for use only with the Bio-Console.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031700 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031700: Medtronic Resting Heart System, Model AAR1000 and 711.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031700

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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