# K955447: Tympanostomy Tube

- Pathway: 510(k) (Traditional)
- Applicant: Trebay Medical Corp.
- Decided: Dec 21, 1995 after 22 days
- Product code: ETD (Tube, Tympanostomy)
- Device class: 2
- Regulation: 21 CFR 874.3880
- Recalls of this device: none
- 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
- K151067: Ventilation (Tympanostomy) Tubes (2015), 0 descendants of its own

Source page: https://510kreport.com/device/K955447
Methodology: https://510kreport.com/methodology