# K151067: Ventilation (Tympanostomy) Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Xomed, Inc.
- Decided: Jul 22, 2015 after 92 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 K900267 (1990). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K791680: Pope Umbrella Tube, Xomed, Inc. (1979) Summary page 5.
- K802587: Otological Ventilation Tubes, Humboldt Products (1980) Summary page 5.
- K822366: Tytan Grommet Vent Tube, .040, Treace Medical, Inc. (1982) Summary page 5.
- K822375: Armstrong V Vent Tube, Treace Medical, Inc. (1982) Summary page 5.
- K823908: Grommet Vent Tube, Treace Medical, Inc. (1983) Summary page 5.
- K823909: T-Tube Vent Tube, Treace Medical, Inc. (1983) Summary page 5.
- K823910: Donaldson Vent Tube, Treace Medical, Inc. (1983) Summary page 5.
- K830584: Soileau Tytan Bobbin Vent Tube, Treace Medical, Inc. (1983) Summary page 5.
- K923353: Ventilation Tubes W/ Hydrogel Coating, Microbio-Medics, Inc. (1993) Summary page 5.
- K943190: C-Flex Vent Tubes, Micromed Development Corp. (1994) Summary page 5.
- K955447: Tympanostomy Tube, Trebay Medical Corp. (1995) Summary page 5.
- K963727: Hoffman H/a Coated Long-Term Ventilation Tube with Liner, Medtronic Xomed (1997) Summary page 6.

## Indications for use
When inserted through a myringotomy, a ventilation tube provides a passageway for movement of air between the auditory canal and the middle ear. The unobstructed passageway may also allow a means of drainage of fluids resulting from acute or chronic otitis media from the middle ear into the auditory canal. In addition, surgical placement of ventilation tubes also provides a means of equalizing air pressures between the outer ear and the middle ear and continued ventilation to prevent fluid accumulation within the middle ear. The surgeon must use medical judgment and consider the patient’s medical history prior to a decision to surgically insert a ventilation tube. Pathologic conditions for which ventilation tubes are indicated include but not limited to: • Chronic otitis media with effusion characterized as 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, otalgia, vertigo and/or tinnitus • Atelectasis resulting from retraction pocket of the tympanic membrane or eustachian tube dysfunction

Source page: https://510kreport.com/device/K151067
Methodology: https://510kreport.com/methodology