# K981575: Tympanostomy Tube

- Pathway: 510(k) (Traditional)
- Applicant: Grace Medical, Inc.
- Decided: Jul 15, 1998 after 72 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K062672: Grace Medical PC Coated Tympanostomy Tubes (2006), 0 descendants of its own

## Indications for use
Indications for insertion of a tympanostomy tube into an incision in the tympanic membrane include any of the following: Chronic otitis media with effusion characterized as either serous, mucoid, or purulent Recurrent acute otitis media which fails to respond satisfactorily to alternative therapies A patient with a history of persistent high negative middle ear pressure which may be associated with conductive hearing loss that is symptomatic, persistant or recurrent otalgia, persistent or recurrent vertigo and/or tinnitus Atelectasis resultant from retraction pocket of the tympanic membrane or eustachian tube dysfunction

Source page: https://510kreport.com/device/K981575
Methodology: https://510kreport.com/methodology