# K892377: Rmi Aortic Root/Coronary Sinus Monit./Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Research Medical, Inc.
- Decided: Dec 7, 1989 after 245 days
- Product code: DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4290
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Oct 19, 2010 · Not classified · Z-0542-2011: Monitoring and Infusion Set connectors may break during manipulation.
- Oct 19, 2010 · Not classified · Z-0543-2011: Monitoring and Infusion Set connectors may break during manipulation.

Source page: https://510kreport.com/device/K892377
Methodology: https://510kreport.com/methodology