# K133157: Tri-Optic Measurement Cell; with Balance Biosurface, with Carmeda Bioactive Surface, with Trillium Biosurface, with 6

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Oct 23, 2014 after 371 days
- Product code: DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K910421 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910421: Saturation/Hematocrit Monitor System, Medtronic Vascular (1991) Summary page 4.
- K093650: Biotrend Oxygen Saturation and Hematocrit System, Medtronic, Inc. (2010) Summary page 4.
- K012743: Trillium Tri-Optic Measurement Cell, Model TMC 25T, TMC38 T, TMC 50T, Medtronic Perfusion Systems (2001) Summary page 4.

## Indications for use
The BioTrend oxygen saturation and hematocrit system measures percent oxygen saturation and hematocrit of the blood in the extracorporeal circuit. The extracorporeal circuit is used for, but is not limited to, cardiopulmonary bypass, closed-chest support, and limb perfusion.

Source page: https://510kreport.com/device/K133157
Methodology: https://510kreport.com/methodology