# K963698: CM02 Cuvette, 1/2, CM02 Cuvette, 3/8 and CM02 Cuvette, 1/4

- Pathway: 510(k) (Traditional)
- Applicant: International Biophysics Corp.
- Decided: Mar 20, 1997 after 185 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; 2 cite 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. The FDA summary names its predicate without a number.
- (no number) Bentley OTC Flow Through Cuvette: named in the summary without a submission number

## Most influential descendants
- K972574: Stela Model UJ45 Pacing Leads (1998), 1 descendant of its own
- K993448: Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45 J-Shaped Tined Pacing Leads (2000), 0 descendants of its own

## Indications for use
The IBC CMO2 Flow Through Cuvette is a single piece, single use, disposable component intended for use with the Bentley OxySat Monitor as a direct substitute for the Bentley OTC Flow Through Cuvette.

Source page: https://510kreport.com/device/K963698
Methodology: https://510kreport.com/methodology