# K031700: Medtronic Resting Heart System, Model AAR1000 and 711

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Perfusion Systems
- Decided: Aug 29, 2003 after 88 days
- Product code: DTN (Reservoir, Blood, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K891687 (1989). 4 ancestors in all.
13 later devices descend from it; 3 cite it directly.
2 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935717: Affinity Venous Reservior Bag, Avecor Cardiovascular, Inc. (1994) Summary page 2.
- K891687: Extracorporeal Circuit with Bio-Active Surface, Medtronic Blood Systems, Inc. (1989) Summary page 2.
- K953564: Medtronic Overpressure/Vacuum Relief Valve, Medtronic Cardiac Surgery, Medtronic, Inc. (1996) Summary page 2.
- K012325: Cardiovention Corx System, Model FG 0001, Cardiovention, Inc. (2002)

## Most influential descendants
- K111972: Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity Hollow Fiber Oxygenator,Aaf (2011), 5 descendants of its own
- K090006: Lifebridge B2T, Model 7001 (2009), 5 descendants of its own
- K120988: DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single Stage Venous Cannula with Right (2012), 4 descendants of its own
- K140165: MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage Venous Cannula, MC2X Three-Stage VE (2014), 2 descendants of its own
- K102726: Cardiohelp System (2011), 2 descendants of its own

## Recalls of this device
- May 9, 2008 · Not classified · Z-1919-2008: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K031700
Methodology: https://510kreport.com/methodology