# K915265: Cdi (TM) H/S Cuvette, Modification

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Jan 15, 1992 after 57 days
- Product code: DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4330
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K082321: Terumo Rocsafe Hybrid Perfusion System (2009), 0 descendants of its own

## Recalls of this device
- Dec 11, 2015 · Class III · Z-0001-2017: Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor displaying the H/S DISCONNECT AT CUVETTE error message when the CDI H/S Cuvette does not make a proper 

Source page: https://510kreport.com/device/K915265
Methodology: https://510kreport.com/methodology