# K902114: Cuff-Mate 2 Endotracheal Cuff Inflator & Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Diemolding Corp.
- Decided: Jul 18, 1990 after 68 days
- Product code: BSK (Cuff, Tracheal Tube, Inflatable)
- Device class: 2
- Regulation: 21 CFR 868.5750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
28 later devices descend from it; 1 cites it directly.
8 of 29 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
- K092733: PYTON (2010), 27 descendants of its own
- K103803: Hamilton-G5 (2011), 14 descendants of its own
- K131774: Hamilton-G5 (2013), 10 descendants of its own
- K121225: Hamilton-C2 (2012), 8 descendants of its own
- K150893: IntelliCuff (2016), 5 descendants of its own

Source page: https://510kreport.com/device/K902114
Methodology: https://510kreport.com/methodology