# K093650: Biotrend Oxygen Saturation and Hematocrit System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Feb 17, 2010 after 84 days
- Product code: DTY (Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4410
- 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 K954501 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954501: Biotrend Oxygen Saturation & Hematocrit System, Medtronic Bio-Medicus, Inc. (1996) Summary page 1.

## Most influential descendants
- K133157: Tri-Optic Measurement Cell; with Balance Biosurface, with Carmeda Bioactive Surface, with Trillium Biosurface, with 6 (2014), 0 descendants of its own

## Indications for use
The BioTrend Oxygen Saturation and Hemnatocrit Systemn measures percent oxygen saturation and hemnatocrit of the blood in the extracorporeal circuit. The extracorporeal circuit is used for, but is not limited to, cardiopulmonary bypass, closed-chiest support, and limnb perfusion.

Source page: https://510kreport.com/device/K093650
Methodology: https://510kreport.com/methodology