510(k) · Cleared
ClearedTula Tympanostomy Tube Delivery Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tusker Medical, Inc. · ETD Tube, Tympanostomy
Cleared on Apr 23, 2026 as substantially equivalent to K221254 (Preceptis Medical, Inc., 2022) after a 265-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Apr 23, 2026
- Review
- 265 days
- Class
- Class II
- Product code
- ETD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K973226 (1997). No later device cites it as a predicate yet.
- Root · 6 generations backK973226 Tubingen Tympanic Ventilation Tube, Tympanic Ventilation Tubes with…Heinz Kurz GmbH Medizintechnik · 1997
- 5 generations backK071150 Trocar Ventilation Tube/with Trocar Tip, Trocar Handle, Model 1015…Heinz Kurz GmbH Medizintechnik · 2007
- 4 generations backK133921 Preceptis Tympanostomy Tube InserterPreceptis Medical · 2014
- 3 generations backK142282 Hummingbird (TM) Tympanostomy Tube System (TTS)Preceptis Medical · 2015
- 2 generations backK200952 Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc. · 2020
- 1 generation backK221254 Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc. · 2022
- This deviceK252436 Tula Tympanostomy Tube Delivery DeviceTusker Medical, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K973226 | Tubingen Tympanic Ventilation Tube, Tympanic Ventilation Tubes with Ene/S… | Heinz Kurz GmbH Medizintechnik | 1997 | — |
| −5 | K071150 | Trocar Ventilation Tube/with Trocar Tip, Trocar Handle, Model 1015 074, 1015… | Heinz Kurz GmbH Medizintechnik | 2007 | — |
| −4 | K133921 | Preceptis Tympanostomy Tube Inserter | Preceptis Medical | 2014 | — |
| −3 | K142282 | Hummingbird (TM) Tympanostomy Tube System (TTS) | Preceptis Medical | 2015 | — |
| −2 | K200952 | Hummingbird Tympanostomy Tube System | Preceptis Medical, Inc. | 2020 | — |
| −1 | K221254 | Hummingbird Tympanostomy Tube System | Preceptis Medical, Inc. | 2022 | — |
| 0 (this device) | K252436 | Tula Tympanostomy Tube Delivery Device | Tusker Medical, Inc. | 2026 | — |
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 K232702 Solo+ Tympanostomy Tube Device (TTD)score 11.6 · 5 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.
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 29 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K221254.
How does its category compare?
All ETD devicesETD Tube, Tympanostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Tympanostomy Tube Delivery 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 or operating room settings for pediatric (aged 6 months and older) and adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252436 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252436: Tula Tympanostomy Tube Delivery Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252436
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026