# K012743: Trillium Tri-Optic Measurement Cell, Model TMC 25T, TMC38 T, TMC 50T

- Pathway: 510(k) (Special)
- Applicant: Medtronic Perfusion Systems
- Decided: Sep 14, 2001 after 29 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: 1 generation back to K910421 (1991). 2 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 10 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 1.
- K973760: Affinity Hollow Fiber Oxygenator with Trillium Biopassive Surface, Avecor Cardiovascular, Inc. (1998) Summary page 2.

## Most influential descendants
- K111972: Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity Hollow Fiber Oxygenator,Aaf (2011), 5 descendants of its own
- K120988: DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single Stage Venous Cannula with Right (2012), 4 descendants of its own
- K140165: MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage Venous Cannula, MC2X Three-Stage VE (2014), 2 descendants of its own
- K251258: MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (2025), 1 descendant of its own
- K262052: Tri Stage Venous Cannulae (2026), 0 descendants of its own

## Indications for use
The Trillium™ Tri-optic Measurement Cell is intended for use in the BioTrend oxygen saturation and hematocrit system. 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/K012743
Methodology: https://510kreport.com/methodology