# K992222: Fluoroplastic Ventilation Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Ent LLC
- Decided: Aug 26, 1999 after 56 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Fluoroplastic tubes marketed by Smith & Nephew, Inc., ENT Division: named in the summary without a submission number
- (no number) Fluoroplastic tubes marketed by Xomed: named in the summary without a submission number

## Most influential descendants
- K062385: Blue Ptfe (Fluoroplastic) Ventilation Tubes (2006), 1 descendant of its own
- 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 Retraction pocket of the tympanic membrane

Source page: https://510kreport.com/device/K992222
Methodology: https://510kreport.com/methodology