510(k) · Cleared
ClearedPreceptis Tympanostomy Tube Inserter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Preceptis Medical · ETD Tube, Tympanostomy
Cleared on Aug 22, 2014 as substantially equivalent to K071150 (Heinz Kurz GmbH Medizintechnik, 2007) after a 242-day review. Its family tree reaches back 2 generations to 1997. 6 later devices descend from it.
- Decided
- Aug 22, 2014
- Review
- 242 days
- Class
- Class II
- Product code
- ETD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K973226 (1997). 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK973226 Tubingen Tympanic Ventilation Tube, Tympanic Ventilation Tubes with…Heinz Kurz GmbH Medizintechnik · 1997
- 1 generation backK071150 Trocar Ventilation Tube/with Trocar Tip, Trocar Handle, Model 1015…Heinz Kurz GmbH Medizintechnik · 2007
- This deviceK133921 Preceptis Tympanostomy Tube InserterPreceptis Medical · 2014
- Descendant · cites it directly · 5 of its ownK142282 Hummingbird (TM) Tympanostomy Tube System (TTS)Preceptis Medical · 2015
- Descendant · 2 generations on · 4 of its ownK200952 Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc. · 2020
- Descendant · 3 generations on · 2 of its ownK221254 Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK232702 Solo+ Tympanostomy Tube Device (TTD)Aventamed Dac · 2024
- Descendant · 4 generations on · 0 of its ownK252436 Tula Tympanostomy Tube Delivery DeviceTusker Medical, Inc. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K142282Hummingbird (TM) Tympanostomy Tube System (TTS)Preceptis Medical · 2015 · cites it directly5descendants
- K200952Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc. · 2020 · 2 generations on4descendants
- K221254Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc. · 2022 · 3 generations on2descendants
- K232702Solo+ Tympanostomy Tube Device (TTD)Aventamed Dac · 2024 · 3 generations on1descendant
- K252436Tula Tympanostomy Tube Delivery DeviceTusker Medical, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973226 | Tubingen Tympanic Ventilation Tube, Tympanic Ventilation Tubes with Ene/S… | Heinz Kurz GmbH Medizintechnik | 1997 | — |
| −1 | K071150 | Trocar Ventilation Tube/with Trocar Tip, Trocar Handle, Model 1015 074, 1015… | Heinz Kurz GmbH Medizintechnik | 2007 | — |
| 0 (this device) | K133921 | Preceptis Tympanostomy Tube Inserter | Preceptis Medical | 2014 | — |
| +1 | K142282 | Hummingbird (TM) Tympanostomy Tube System (TTS) | Preceptis Medical | 2015 | — |
| +2 | K200952 | Hummingbird Tympanostomy Tube System | Preceptis Medical, Inc. | 2020 | — |
| +3 | K221254 | Hummingbird Tympanostomy Tube System | Preceptis Medical, Inc. | 2022 | — |
| +3 | K232702 | Solo+ Tympanostomy Tube Device (TTD) | Aventamed Dac | 2024 | — |
| +4 | K252436 | Tula Tympanostomy Tube Delivery Device | Tusker Medical, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K071150 | Trocar Ventilation Tube/with Trocar Tip, Trocar Handle, Model 1015 074, 1015 076, 1015…Summary page 4…ETD (21 CFR Part 874.3880) Common Name Preceptis Tympanostomy Tube System Predicate Device Heinz Kurz Trocar Ventilation Tube, 510(k) K071150 Device The Preceptis Tympanostomy Tube System (TTS) which includes a Description tympanos… | 2007 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142282 | Hummingbird (TM) Tympanostomy Tube System (TTS) | 2015 | 5 |
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 17 years and passes through 2 companies; a new generation was cleared every 10.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K142282 (Preceptis Medical, 2015) has gone furthest, with 5 descendants of its own.
How does its category compare?
All ETD devicesETD Tube, Tympanostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 System is intended to deliver a tympanostomy tube in tympanostomy procedures in which the patient is receiving a tympanostomy tube.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K133921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133921: Preceptis Tympanostomy Tube Inserter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133921
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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