# K954501: Biotrend Oxygen Saturation & Hematocrit System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Bio-Medicus, Inc.
- Decided: Jan 16, 1996 after 110 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
No predicates in its family tree.
2 later devices descend 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K093650: Biotrend Oxygen Saturation and Hematocrit System (2010), 1 descendant of its own
- K133157: Tri-Optic Measurement Cell; with Balance Biosurface, with Carmeda Bioactive Surface, with Trillium Biosurface, with 6 (2014), 0 descendants of its own

Source page: https://510kreport.com/device/K954501
Methodology: https://510kreport.com/methodology