510(k) · Cleared
Recalled · Class II · 2014Otological Ventilation Tubes-Various
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micromedics, Inc. · ETD Tube, Tympanostomy
Cleared on Mar 7, 1983 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it. It has been recalled once.
- Decided
- Mar 7, 1983
- Review
- 42 days
- Class
- Class II
- Product code
- ETD
- Recalls
- 1
- Predicates
- 0
6 later devices descend from it, 5 citing it directly.
- This deviceK830228 Otological Ventilation Tubes-VariousMicromedics, Inc. · 1983
- Descendant · cites it directly · 2 of its ownK082188 Tympanostomy TubeAcclarent, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK103595 Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery SystemAcclarent, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK233658 Biowy Tym Tube (TT)Biowy Corporation · 2024
- Descendant · cites it directly · 0 of its ownK232059 Tympanostomy TubesGrace Medical, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK171239 TULA Tube Delivery SystemTusker Medical · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K082188Tympanostomy TubeAcclarent, Inc. · 2008 · cites it directly2descendants
- K103595Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery SystemAcclarent, Inc. · 2011 · cites it directly1descendant
- K233658Biowy Tym Tube (TT)Biowy Corporation · 2024 · cites it directly0descendants
- K232059Tympanostomy TubesGrace Medical, Inc. · 2023 · cites it directly0descendants
- K171239TULA Tube Delivery SystemTusker Medical · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K830228 | Otological Ventilation Tubes-Various | Micromedics, Inc. | 1983 | — |
| +1 | K082188 | Tympanostomy Tube | Acclarent, Inc. | 2008 | — |
| +1 | K103595 | Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery System | Acclarent, Inc. | 2011 | — |
| +1 | K233658 | Biowy Tym Tube (TT) | Biowy Corporation | 2024 | — |
| +1 | K232059 | Tympanostomy Tubes | Grace Medical, Inc. | 2023 | — |
| +2 | K171239 | TULA Tube Delivery System | Tusker Medical | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (6)
5 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 12, 2014 | Class II | Z-1731-2014 | Employee error | One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventilation tubes with wire attached to the straight flange. This poses no health hazard to the user or patient. |
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/K830228 · printed Nov 6, 2026
Cite this page
510(k) Report. “K830228: Otological Ventilation Tubes-Various.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K830228
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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