# 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))

- Pathway: 510(k) (Traditional)
- Applicant: Aventamed Dac
- Decided: Apr 28, 2025 after 90 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232702: Solo+ Tympanostomy Tube Device (TTD), Aventamed Dac (2024) Summary page 7.
- K221254: Hummingbird Tympanostomy Tube System, Preceptis Medical, Inc. (2022) Summary page 7.

## 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 months and older.

Source page: https://510kreport.com/device/K250256
Methodology: https://510kreport.com/methodology