# K071178: Otomedics Soft Tympanostomy Tube

- Pathway: 510(k) (Traditional)
- Applicant: Otomedics Advanced Medical Technologies, Ltd.
- Decided: Jun 22, 2007 after 56 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
Longest line of descent: 1 generation back to K781257 (1978). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K852387: Goode T-Tube White Silicone Tympanostomy Tube, Xomed, Inc. (1986) Summary page 2.
- K941407: Tympanostomy (Ventilation) Tube, Xomed-Treace, Inc. (1995) Summary page 2.
- K822375: Armstrong V Vent Tube, Treace Medical, Inc. (1982) Summary page 2.
- K781257: Ventilation Tube Sili. Sheppard Type, Xomed, Inc. (1978) Summary page 2.
- K791680: Pope Umbrella Tube, Xomed, Inc. (1979) Summary page 2.

## Indications for use
Otomedics Soft Tympanostomy Tube is a device that is intended to be implanted for ventilation or drainage of the middle ear.

Source page: https://510kreport.com/device/K071178
Methodology: https://510kreport.com/methodology