# K122811: Connector Components with Balance Biosurface

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Oct 12, 2012 after 29 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: 3 generations back to K800178 (1980). 6 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113845: Tubing, Conmnectors, and Accessories Wit Balance Biosurface, Medtronic, Inc. (2012) Summary page 1.

## Most influential descendants
- 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
- K213540: Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set (2022), 0 descendants of its own

## Recalls of this device
- 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

## Indications for use
Medtronic Connector Components with BalanceTM Biosurface are indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgical procedures.

Source page: https://510kreport.com/device/K122811
Methodology: https://510kreport.com/methodology