510(k) · Cleared
ClearedHummingbird Tympanostomy Tube System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Preceptis Medical, Inc. · ETD Tube, Tympanostomy
Cleared on Jul 27, 2022 as substantially equivalent to K200952 (Preceptis Medical, Inc., 2020) after an 86-day review. Its family tree reaches back 5 generations to 1997. 2 later devices descend from it.
- Decided
- Jul 27, 2022
- Review
- 86 days
- Class
- Class II
- Product code
- ETD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K973226 (1997). 2 later devices descend from it, 2 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 deviceK221254 Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK252436 Tula Tympanostomy Tube Delivery DeviceTusker Medical, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK250256 Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+…Aventamed Dac · 2025
Most influential descendants
Showing 2 of 2 · See allView 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) | K221254 | Hummingbird Tympanostomy Tube System | Preceptis Medical, Inc. | 2022 | — |
| +1 | K252436 | Tula Tympanostomy Tube Delivery Device | Tusker Medical, Inc. | 2026 | — |
| +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 |
| 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 |
|---|---|---|---|
| * | K200952 | Hummingbird Tympanostomy Tube SystemSummary page 4…80) Classification Class II Common Tympanostomy Tube Inserter with pre-loaded ventilation tube Name Predicate Preceptis Tympanostomy Tube System, K200952 Devices Device The Hummingbird® Tympanostomy Tube System (HTTS), which includes a Description preloaded ventilati… | 2020 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 25 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K252436 (Tusker Medical, Inc., 2026) 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. 2022, 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 Hummingbird® Tympanostomy Tube System (HTTS) 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 months and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221254 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221254: Hummingbird Tympanostomy Tube System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221254
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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