# K252436: Tula Tympanostomy Tube Delivery Device

- Pathway: 510(k) (Traditional)
- Applicant: Tusker Medical, Inc.
- Decided: Apr 23, 2026 after 265 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: 6 generations back to K973226 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221254: Hummingbird Tympanostomy Tube System, Preceptis Medical, Inc. (2022) Summary page 5.

## Indications for use
The Tula Tympanostomy Tube Delivery Device is intended to deliver a tympanostomy tube (also referred to as a ventilation tube) through the tympanic membrane of the patient and is indicated to be used in office or operating room settings for pediatric (aged 6 months and older) and adult patients.

Source page: https://510kreport.com/device/K252436
Methodology: https://510kreport.com/methodology