510(k) · Cleared
ClearedVentilation (Tympanostomy) Tubes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Xomed, Inc. · ETD Tube, Tympanostomy
Cleared on Jul 22, 2015 as substantially equivalent to K791680 (Xomed, Inc., 1979) and 11 other predicates after a 92-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Jul 22, 2015
- Review
- 92 days
- Class
- Class II
- Product code
- ETD
- Recalls
- None
- Predicates
- 12
Its longest line of descent runs back 2 generations to K900267 (1990). 13 ancestors in all, the oldest K791680 (1979). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K900267 | Jahn Ventilation Tube | Smith & Nephew Richards, Inc. | 1990 | — |
| −1 | K963727 | Hoffman H/a Coated Long-Term Ventilation Tube with Liner | Medtronic Xomed | 1997 | — |
| 0 (this device) | K151067 | Ventilation (Tympanostomy) Tubes | Medtronic Xomed, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1983 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ETD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ETD device
- #1 K252436 Tula Tympanostomy Tube Delivery Devicescore 12.7 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (12)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K791680 | Pope Umbrella TubeSummary page 5…premarket notifications: Description 510(k) Number Clearance Date Pope Umbrella Tube K791680 11/13/1979 Otological Ventilation Tubes K802587 11/12/1980 Tytan® Gro… | 1979 |
| * | K802587 | Otological Ventilation TubesSummary page 5…510(k) Number Clearance Date Pope Umbrella Tube K791680 11/13/1979 Otological Ventilation Tubes K802587 11/12/1980 Tytan® Grommet Vent Tube, 09/02/1982… | 1980 |
| * | K822366 | Tytan Grommet Vent Tube, .040Summary page 5…es K802587 11/12/1980 Tytan® Grommet Vent Tube, 09/02/1982 K822366 .040 09/09/1982 Armstrong V… | 1982 |
| * | K822375 | Armstrong V Vent TubeSummary page 5…K822366 .040 09/09/1982 Armstrong V Vent Tube K822375 01/28/1983 Grommet Vent Tube… | 1982 |
| * | K823908 | Grommet Vent TubeSummary page 5…trong V Vent Tube K822375 01/28/1983 Grommet Vent Tube K823908 T-Tube Vent Tube K823909 03/17/1983 Donaldson Vent Tubes… | 1983 |
| * | K823909 | T-Tube Vent TubeSummary page 5…01/28/1983 Grommet Vent Tube K823908 T-Tube Vent Tube K823909 03/17/1983 Donaldson Vent Tubes K823910 11/22/1983… | 1983 |
| * | K823910 | Donaldson Vent TubeSummary page 5…t Vent Tube K823908 T-Tube Vent Tube K823909 03/17/1983 Donaldson Vent Tubes K823910 11/22/1983 06/02/1983 Soileau Tyt… | 1983 |
| * | K830584 | Soileau Tytan Bobbin Vent TubeSummary page 5…K823910 11/22/1983 06/02/1983 Soileau Tytan Bobbin Vent Tube K830584 Ventilation Tubes w/ Hydrogel 05/18/1993… | 1983 |
| * | K923353 | Ventilation Tubes W/ Hydrogel CoatingSummary page 5…Soileau Tytan Bobbin Vent Tube K830584 Ventilation Tubes w/ Hydrogel 05/18/1993 K923353 Coating 08/24/1994 C-Flex Ve… | 1993 |
| * | K943190 | C-Flex Vent TubesSummary page 5…K923353 Coating 08/24/1994 C-Flex Vent Tubes K943190 Tympanostomy Tube K955447 12/21/1995 Ventilation (Tympanostomy) Tubes… | 1994 |
| * | K955447 | Tympanostomy TubeSummary page 5…08/24/1994 C-Flex Vent Tubes K943190 Tympanostomy Tube K955447 12/21/1995 Ventilation (Tympanostomy) Tubes K15XXXX Med… | 1995 |
| * | K963727 | Hoffman H/a Coated Long-Term Ventilation Tube with LinerSummary page 6…1-34 Hoffman H/A Coated Long-Term 02/11/1997 K963727 Ventilation Tube with Liner XI. Comparison of the Technological Characteristics: Feature… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 18.4 years on median.
- None of the 13 ancestors has a recall.
- 1 other device also cites its predicate K791680.
How does its category compare?
All ETD devicesETD Tube, Tympanostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · ETD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ETD
92in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ETD
9in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ETD
1in 2025
MAUDE reports naming product code ETD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 2 | 4 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 3 | 92 | 0 | 4 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 18 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 8 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 1 | — | 1 | 4 |
| 2024 | 2 | — | 9 | 2 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (183 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151067 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151067: Ventilation (Tympanostomy) Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151067
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026