# K062385: Blue Ptfe (Fluoroplastic) Ventilation Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Grace Medical, Inc.
- Decided: Sep 27, 2006 after 43 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). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992222: Fluoroplastic Ventilation Tubes, Gyrus Ent LLC (1999) Summary page 1.
- K943325: Tympanostomy Tube, Grace Medical, Inc. (1994) Summary page 1.

## Most influential descendants
- K232059: Tympanostomy Tubes (2023), 0 descendants of its own

## Indications for use
Chronic otitis media with effusion (serous, mucoid, or purulent) Recurrent episodes of acute otitis media despite conventional medical treatment A record of persistent high negative middle ear pressure associated with one or more of the following system: 1. Conductive hearing loss that is symptomatic 2. Persistent or recurrent otalgia 3. Persistent or recurrent vertigo, tinnitus, or both Atelectasis resultant from retraction pocket of the tympanic membrane or eustachian tube dysfunction.

Source page: https://510kreport.com/device/K062385
Methodology: https://510kreport.com/methodology