# K113845: Tubing, Conmnectors, and Accessories Wit Balance Biosurface

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Jan 25, 2012 after 28 days
- Product code: DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4290
- 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: 2 generations back to K800178 (1980). 5 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K800178: Extracorp.'S Intersept Cus. Tubing PK., Extracorporeal Medical Specialities, Inc. (1980) Summary page 1.
- K883956: Bio-Medicus Tubing Connectors, Bio Medicus, Inc. (1988) Summary page 1.
- K924529: Signature (TM) Custom Tubing Pack, Avecor Cardiovascular, Inc. (1993) Summary page 1.
- K012538: Tubing and Connectors with Trillium Biopassive Surface, Medtronic Vascular (2001)
- K100646: Affinity Pixie Arterial Filter with Balance Biosurface, Medtronic, Inc. (2010) Summary page 1.

## Most influential descendants
- K122811: Connector Components with Balance Biosurface (2012), 5 descendants of its own
- K151523: Uncoated Tubing and Connector Components (2015), 4 descendants of its own
- K171308: Tubing Pack (2017), 3 descendants of its own
- K171979: Tubing Pack (2017), 2 descendants of its own
- K260043: Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) (2026), 0 descendants of its own

## Recalls of this device
- 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 

## Indications for use
This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery procedures.

Source page: https://510kreport.com/device/K113845
Methodology: https://510kreport.com/methodology