# K062672: Grace Medical PC Coated Tympanostomy Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Grace Medical, Inc.
- Decided: Oct 24, 2006 after 46 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: 1 generation back to K943325 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943325: Tympanostomy Tube, Grace Medical, Inc. (1994) Summary page 1.
- K981575: Tympanostomy Tube, Grace Medical, Inc. (1998) Summary page 1.
- K000801: PC Coated Fluoroplastic Vent Tubes, Gyrus Ent LLC (2000)

## Indications for use
(a) Chronic otitis media with effusion (serous, mucoid, or purulent). (b) Recurrent episodes of acute otitis media despite conventional medical treatment. (c) A record of persistent high negative middle ear pressure associated with one or more of the following symptoms: (i) Conductive hearing loss that is symptomatic. (ii) Persistent or recurrent otalgia. (iii) Persistent or recurrent vertigo, tinnitus, or both. (d) Retraction pocket of the tympanic membrane.

Source page: https://510kreport.com/device/K062672
Methodology: https://510kreport.com/methodology