# K003567: Serenocem, Model BC 010

- Pathway: 510(k) (Traditional)
- Applicant: Corinthian Medical, Ltd.
- Decided: Feb 12, 2001 after 84 days
- Product code: NEA (Cement, Ear, Nose And Throat)
- Device class: 2
- Regulation: 21 CFR 872.3275
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K080032: Envoycem, Model 1640 (2008), 1 descendant of its own
- K140644: Procem (2014), 0 descendants of its own

Source page: https://510kreport.com/device/K003567
Methodology: https://510kreport.com/methodology