510(k) · Cleared
ClearedAcclarent Tympanostomy Tube and Tympanostomy Tube Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acclarent, Inc. · ETD Tube, Tympanostomy
Cleared on Apr 1, 2011 as substantially equivalent to K830228 (Micromedics, Inc., 1983) and 2 other predicates after a 114-day review. Its family tree reaches back 2 generations to 1983. 1 later device descends from it.
- Decided
- Apr 1, 2011
- Review
- 114 days
- Class
- Class II
- Product code
- ETD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K830228 (1983). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK830228 Otological Ventilation Tubes-VariousMicromedics, Inc. · 1983 · Recalled
- 1 generation backK082188 Tympanostomy TubeAcclarent, Inc. · 2008
- This deviceK103595 Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery SystemAcclarent, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK171239 TULA Tube Delivery SystemTusker Medical · 2017
Most influential descendants
Showing 1 of 1 · See all- K171239TULA Tube Delivery SystemTusker Medical · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K830228 | Otological Ventilation Tubes-Various | Micromedics, Inc. | 1983 | 1 |
| −1 | K082188 | Tympanostomy Tube | Acclarent, Inc. | 2008 | — |
| 0 (this device) | K103595 | Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery System | Acclarent, Inc. | 2011 | — |
| +1 | 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 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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…4.3880 Classification Name: Tube, Tympanostomy Product Code: ETD Predicate Devices: Heinz Kurz GmbH Medizintechnik Trocar Ventilation Tube (K830228) Acclarent Tympanostomy Tube (K082188) Exmoor Plastics Ltd. Myringotomy Kit… | 1983 |
| * | K082188 | Tympanostomy TubeSummary page 1…de: ETD Predicate Devices: Heinz Kurz GmbH Medizintechnik Trocar Ventilation Tube (K830228) Acclarent Tympanostomy Tube (K082188) Exmoor Plastics Ltd. Myringotomy Kit (K980828) Device Description: The Tympanostomy Tube Deli… | 2008 |
| * | K980828 | Exmoor Myringotomy KitSummary page 1…chnik Trocar Ventilation Tube (K830228) Acclarent Tympanostomy Tube (K082188) Exmoor Plastics Ltd. Myringotomy Kit (K980828) Device Description: The Tympanostomy Tube Delivery System is a device that penetrates the tym… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171239 | TULA Tube Delivery System | 2017 | 0 |
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 28 years and passes through 2 companies; a new generation was cleared every 25.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K171239 (Tusker Medical, 2017) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K830228.
How does its category compare?
All ETD devicesETD Tube, Tympanostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The Tympanostomy Tube Delivery System is intended to provide a means to create a myringotomy with insertion of a preloaded Paparella type tympanostomy tube.
Conditions for which tympanostomy tubes are indicated include:
Chronic otitis media with effusion (serous, mucoid, or purulent)
Recurrent otitis media that fails to respond to conventional medical treatment
A history of persistent high negative middle ear pressure which may be associated with conductive hearing loss, otalgia, vertigo and/or tinnitus.
Retraction pocket of the tympanic membrane.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103595 · printed Nov 4, 2026
Cite this page
510(k) Report. “K103595: Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K103595
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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