510(k) · Cleared
ClearedTULA Tube Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tusker Medical · ETD Tube, Tympanostomy
Cleared on Jun 28, 2017 as substantially equivalent to K103595 (Acclarent, Inc., 2011) after a 62-day review. Its family tree reaches back 3 generations to 1983.
- Decided
- Jun 28, 2017
- Review
- 62 days
- Class
- Class II
- Product code
- ETD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K830228 (1983). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK830228 Otological Ventilation Tubes-VariousMicromedics, Inc. · 1983 · Recalled
- 2 generations backK082188 Tympanostomy TubeAcclarent, Inc. · 2008
- 1 generation backK103595 Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery SystemAcclarent, Inc. · 2011
- This deviceK171239 TULA Tube Delivery SystemTusker Medical · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K830228 | Otological Ventilation Tubes-Various | Micromedics, Inc. | 1983 | 1 |
| −2 | K082188 | Tympanostomy Tube | Acclarent, Inc. | 2008 | — |
| −1 | K103595 | Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery System | Acclarent, Inc. | 2011 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K103595 | Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery SystemSummary page 4…Number: 21 CFR 874.3880 Classification Name: Tube, Tympanostomy Product Code: ETD Predicate Device: Tympanostomy Tube Delivery System (K103595) Device Description: The Tula Tube Delivery System (TDS) is a device that penetrates the tympani… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 34 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- 1 of the 6 ancestors has a recall of any class.
How does its category compare?
All ETD devicesETD Tube, Tympanostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Tula Tube Delivery System is intended to provide a means to create a myringotomy with insertion of a preloaded Grommet type tympanostomy tube.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171239 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171239: TULA Tube Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171239
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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