# K232702: Solo+ Tympanostomy Tube Device (TTD)

- Pathway: 510(k) (Traditional)
- Applicant: Aventamed Dac
- Decided: May 20, 2024 after 258 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: 5 generations back to K973226 (1997). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200952: Hummingbird Tympanostomy Tube System, Preceptis Medical, Inc. (2020) Summary page 5.

## Most influential descendants
- K250256: Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000)) (2025), 0 descendants of its own

## Indications for use
The Solo+ Tympanostomy Tube 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 settings for pediatric patients 6-24 months old.

Source page: https://510kreport.com/device/K232702
Methodology: https://510kreport.com/methodology