# K891687: Extracorporeal Circuit with Bio-Active Surface

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Blood Systems, Inc.
- Decided: May 31, 1989 after 70 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
73 later devices descend from it; 8 cite it directly.
4 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K973011: BPX80 Bio-Pump (BPX80) (1998), 48 descendants of its own
- K020271: Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100 (2003), 21 descendants of its own
- K031827: Ultraflex Venous Cannula, Model 970XX and CB970XX (2003), 15 descendants of its own
- K031700: Medtronic Resting Heart System, Model AAR1000 and 711 (2003), 13 descendants of its own
- K991783: AB-180 XC System, Model AB-180XC (2000), 13 descendants of its own

## Recalls of this device
- Aug 8, 2018 · Class II · Z-2495-2020: Affected products failed a sterilization test.
- Feb 4, 2016 · Class III · Z-1023-2016: Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs that include the potentially affected cuvettes manufactured by Terumo Cardiovascular Systems 
- Aug 18, 2015 · Class II · Z-2736-2015: Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is below product specification. These potentially affected units have been distributed as stand-alone device
- Jul 17, 2013 · Class II · Z-2105-2013: Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactu
- Nov 19, 2012 · Class II · Z-0618-2013: Medtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that certain Medtronic Intersept Tubing Packs contain packaging trays that are susceptible to damage that can 
- Dec 14, 2011 · Not classified · Z-0813-2012: Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a co
- May 9, 2008 · Not classified · Z-1920-2008: 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.
- Aug 1, 2007 · Not classified · Z-1227-2007: Medtronic Custom Tubing Packs might have open header bag seals.
- Jan 2, 2007 · Not classified · Z-0583-2007: One lot of Custom Perfusion Sets, Catalog 2T10R1 was incorrectly assembled. The one way vacuum relief valve on the 102 inch line is attached backwards, thus preventing flow.
- Sep 15, 2004 · Not classified · Z-1489-04: Spiral tip from DLP VAD cannula may be loose and potentially detach during use.

Source page: https://510kreport.com/device/K891687
Methodology: https://510kreport.com/methodology