510(k) · Cleared
ClearedTympanostomy Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acclarent, Inc. · ETD Tube, Tympanostomy
Cleared on Sep 19, 2008 as substantially equivalent to K830228 (Micromedics, Inc., 1983) and 2 other predicates after a 46-day review. Its family tree reaches back 1 generation to 1983. 2 later devices descend from it.
- Decided
- Sep 19, 2008
- Review
- 46 days
- Class
- Class II
- Product code
- ETD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K830228 (1983). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK830228 Otological Ventilation Tubes-VariousMicromedics, Inc. · 1983 · Recalled
- This deviceK082188 Tympanostomy TubeAcclarent, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK103595 Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery SystemAcclarent, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK171239 TULA Tube Delivery SystemTusker Medical · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K830228 | Otological Ventilation Tubes-Various | Micromedics, Inc. | 1983 | 1 |
| 0 (this device) | K082188 | Tympanostomy Tube | Acclarent, Inc. | 2008 | — |
| +1 | K103595 | Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery System | Acclarent, Inc. | 2011 | — |
| +2 | K171239 | TULA Tube Delivery System | Tusker Medical | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2017 | 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? (3)
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 |
|---|---|---|---|
| * | K830228 | Otological Ventilation Tubes-VariousSummary page 1…21 CFR 874.3880 Classification Name: Tube, Tympanostomy Product Code: ETD Predicate Devices: MicroMedics Otological Ventilation Tube (K830228) Xomed Activent Ventilation Tube (K941407) Exmoor Plastics Ltd. Donaldson… | 1983 |
| * | K941407 | Tympanostomy (Ventilation) TubeSummary page 1…oduct Code: ETD Predicate Devices: MicroMedics Otological Ventilation Tube (K830228) Xomed Activent Ventilation Tube (K941407) Exmoor Plastics Ltd. Donaldson Vent-Mini Tube (K911580) Device Description: The Tympanostom… | 1995 |
| * | K911580 | Donaldson/Shepards DR/Collar/Shah Vent-Mini TubesSummary page 1…ntilation Tube (K830228) Xomed Activent Ventilation Tube (K941407) Exmoor Plastics Ltd. Donaldson Vent-Mini Tube (K911580) Device Description: The Tympanostomy Tube is a silicone tube that is intended to provide ve… | 1991 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103595 | Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery System | 2011 | 1 |
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?
How does its category compare?
All ETD devicesETD Tube, Tympanostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Conditions for which tympanostomy tubes are indicated include:
o Chronic otitis media with effusion (serous, mucoid, or purulent)
o Recurrent otitis media that fails to respond to conventional medical treatment
o A history of persistent high negative middle ear pressure which may be associated with conductive hearing loss, otalgia, vertigo and/or tinnitus.
o Retraction pocket of the tympanic membrane.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082188: Tympanostomy Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082188
Report an extraction error
Are you the manufacturer?
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