510(k) · Cleared
ClearedSolo+ Tympanostomy Tube Device (TTD)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aventamed Dac · ETD Tube, Tympanostomy
Cleared on May 20, 2024 as substantially equivalent to K200952 (Preceptis Medical, Inc., 2020) after a 258-day review. Its family tree reaches back 5 generations to 1997. 1 later device descends from it.
- Decided
- May 20, 2024
- Review
- 258 days
- Class
- Class II
- Product code
- ETD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K973226 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK973226 Tubingen Tympanic Ventilation Tube, Tympanic Ventilation Tubes with…Heinz Kurz GmbH Medizintechnik · 1997
- 4 generations backK071150 Trocar Ventilation Tube/with Trocar Tip, Trocar Handle, Model 1015…Heinz Kurz GmbH Medizintechnik · 2007
- 3 generations backK133921 Preceptis Tympanostomy Tube InserterPreceptis Medical · 2014
- 2 generations backK142282 Hummingbird (TM) Tympanostomy Tube System (TTS)Preceptis Medical · 2015
- 1 generation backK200952 Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc. · 2020
- This deviceK232702 Solo+ Tympanostomy Tube Device (TTD)Aventamed Dac · 2024
- Descendant · cites it directly · 0 of its ownK250256 Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+…Aventamed Dac · 2025
Most influential descendants
Showing 1 of 1 · See all- K250256Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube…Aventamed Dac · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K973226 | Tubingen Tympanic Ventilation Tube, Tympanic Ventilation Tubes with Ene/S… | Heinz Kurz GmbH Medizintechnik | 1997 | — |
| −4 | K071150 | Trocar Ventilation Tube/with Trocar Tip, Trocar Handle, Model 1015 074, 1015… | Heinz Kurz GmbH Medizintechnik | 2007 | — |
| −3 | K133921 | Preceptis Tympanostomy Tube Inserter | Preceptis Medical | 2014 | — |
| −2 | K142282 | Hummingbird (TM) Tympanostomy Tube System (TTS) | Preceptis Medical | 2015 | — |
| −1 | K200952 | Hummingbird Tympanostomy Tube System | Preceptis Medical, Inc. | 2020 | — |
| 0 (this device) | K232702 | Solo+ Tympanostomy Tube Device (TTD) | Aventamed Dac | 2024 | — |
| +1 | K250256 | Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy… | Aventamed Dac | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K200952 | Hummingbird Tympanostomy Tube SystemSummary page 5…ed to be used in office settings for pediatric patients 6-24 months old. Predicate Device • Hummingbird Tympanostomy Tube System (HTTS), Preceptis Medical Inc. (K200952) Reference Device • Otological Ventilation Tube - Sheehy Design, Micromedics, Inc. (K830228) Device Description The Solo… | 2020 |
| † | K830228 | Otological Ventilation Tubes-Various | 1983 |
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 |
|---|---|---|---|
| K250256 | Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube… | 2025 | 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 27 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K250256 (Aventamed Dac, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K200952.
How does its category compare?
All ETD devicesETD Tube, Tympanostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube (also referred to as a ventilation tube) through the tympanic membrane of the patient and is indicated to be used in office settings for pediatric patients 6-24 months old.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232702 · printed Nov 4, 2026
Cite this page
510(k) Report. “K232702: Solo+ Tympanostomy Tube Device (TTD).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K232702
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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