# K123448: Affinity Flexible Luer Lock Adapter with Balance Biosurface, Affinity Flexible Luer Lock Adapter with Carmeda Bioactive

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Dec 13, 2012 after 35 days
- Product code: DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K936003 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100645: Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance Biosurface, Medtronic, Inc. (2012) Summary page 1.

## Indications for use
Flexible Luer Lock Adapters are indicated for use in connecting tubing and/or devices during cardiopulmonary bypass procedures up to 6 hours in duration.

Source page: https://510kreport.com/device/K123448
Methodology: https://510kreport.com/methodology