# K232059: Tympanostomy Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Grace Medical, Inc.
- Decided: Nov 24, 2023 after 136 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: 2 generations back to K943325 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062385: Blue Ptfe (Fluoroplastic) Ventilation Tubes, Grace Medical, Inc. (2006) Summary page 4.
- K830228: Otological Ventilation Tubes-Various, Micromedics, Inc. (1983) Summary page 4.

## Indications for use
1) Chronic otitis media with effusion characterize as either serous, mucoid, or purulent. 2) Recurrent acute otitis media which fails to respond satisfactorily to alternative therapies. 3) A patient with a history of persistent high negative middle ear pressure which may be associated with conductive hearing loss that is symptomatic, persistent or recurrent otalgia, persistent or recurrent vertigo and/or tinnitus. 4) Atelectasis recurrent form retraction pocket of the tympanic membrane or eustachian tube dysfunction.

Source page: https://510kreport.com/device/K232059
Methodology: https://510kreport.com/methodology