# K973472: 3M Cdi H/S Cuvettes with Heparon Treatment

- Pathway: 510(k) (Traditional)
- Applicant: 3M Healthcare
- Decided: Dec 8, 1997 after 87 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 K902654 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902654: Cdi (TM) System 100 Monitoring System, 3M Health Care, Ltd. (1990) Summary page 1.
- K912645: Atriums PDR Thoracic Catheter, Atrium Medical Corp. (1991) Summary page 1.

## Indications for use
These cuvettes are to be used with the CDI 100 Extracorporeal Hematocrit’Oxygen Saturation Monitoring System, which is intended for use during cardiopulmonary bypass procedures when continuous monitoring og blood hematocrit, hemoglobin, and oxygen saturation is desired.

Source page: https://510kreport.com/device/K973472
Methodology: https://510kreport.com/methodology