510(k) · Cleared
ClearedTympanostomy (Ventilation) Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xomed-Treace, Inc. · ETD Tube, Tympanostomy
Cleared on Mar 14, 1995 after a 356-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Mar 14, 1995
- Review
- 356 days
- Class
- Class II
- Product code
- ETD
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK941407 Tympanostomy (Ventilation) TubeXomed-Treace, Inc. · 1995
- Descendant · cites it directly · 2 of its ownK082188 Tympanostomy TubeAcclarent, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK103595 Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery SystemAcclarent, Inc. · 2011
- Descendant · 3 generations on · 0 of its ownK171239 TULA Tube Delivery SystemTusker Medical · 2017
- Descendant · cites it directly · 0 of its ownK071178 Otomedics Soft Tympanostomy TubeOtomedics Advanced Medical Technologies, Ltd. · 2007
Most influential descendants
Showing 4 of 4 · See all- K082188Tympanostomy TubeAcclarent, Inc. · 2008 · cites it directly2descendants
- K103595Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery SystemAcclarent, Inc. · 2011 · 2 generations on1descendant
- K171239TULA Tube Delivery SystemTusker Medical · 2017 · 3 generations on0descendants
- K071178Otomedics Soft Tympanostomy TubeOtomedics Advanced Medical Technologies, Ltd. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941407 | Tympanostomy (Ventilation) Tube | Xomed-Treace, Inc. | 1995 | — |
| +1 | K082188 | Tympanostomy Tube | Acclarent, Inc. | 2008 | — |
| +2 | K103595 | Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery System | Acclarent, Inc. | 2011 | — |
| +3 | K171239 | TULA Tube Delivery System | Tusker Medical | 2017 | — |
| +1 | K071178 | Otomedics Soft Tympanostomy Tube | Otomedics Advanced Medical Technologies, Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K082188 (Acclarent, Inc., 2008) has gone furthest, with 2 descendants of its own.
How does its category compare?
All ETD devicesETD Tube, Tympanostomy: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K941407 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941407: Tympanostomy (Ventilation) Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941407
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026