510(k) · Cleared
ClearedTubingen Tympanic Ventilation Tube, Tympanic Ventilation Tubes with Ene/S, Diabolo Tympanic Ventilation Tube, Minimal T)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heinz Kurz GmbH Medizintechnik · ETD Tube, Tympanostomy
Cleared on Nov 4, 1997 after a 69-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Nov 4, 1997
- Review
- 69 days
- Class
- Class II
- Product code
- ETD
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK973226 Tubingen Tympanic Ventilation Tube, Tympanic Ventilation Tubes with…Heinz Kurz GmbH Medizintechnik · 1997
- Descendant · cites it directly · 7 of its ownK071150 Trocar Ventilation Tube/with Trocar Tip, Trocar Handle, Model 1015…Heinz Kurz GmbH Medizintechnik · 2007
- Descendant · 2 generations on · 6 of its ownK133921 Preceptis Tympanostomy Tube InserterPreceptis Medical · 2014
- Descendant · 3 generations on · 5 of its ownK142282 Hummingbird (TM) Tympanostomy Tube System (TTS)Preceptis Medical · 2015
- Descendant · 4 generations on · 4 of its ownK200952 Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc. · 2020
- Descendant · 5 generations on · 2 of its ownK221254 Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc. · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K071150Trocar Ventilation Tube/with Trocar Tip, Trocar Handle, Model 1015 074, 1015 076, 1015…Heinz Kurz GmbH Medizintechnik · 2007 · cites it directly7descendants
- K133921Preceptis Tympanostomy Tube InserterPreceptis Medical · 2014 · 2 generations on6descendants
- K142282Hummingbird (TM) Tympanostomy Tube System (TTS)Preceptis Medical · 2015 · 3 generations on5descendants
- K200952Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc. · 2020 · 4 generations on4descendants
- K221254Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc. · 2022 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K133921 | Preceptis Tympanostomy Tube Inserter | Preceptis Medical | 2014 | — |
| +3 | K142282 | Hummingbird (TM) Tympanostomy Tube System (TTS) | Preceptis Medical | 2015 | — |
| +4 | K200952 | Hummingbird Tympanostomy Tube System | Preceptis Medical, Inc. | 2020 | — |
| +5 | K221254 | Hummingbird Tympanostomy Tube System | Preceptis Medical, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 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? (9)
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 |
|---|---|---|---|
| * | — | Hubbard Airplane Vent Tube Named without a submission number | |
| * | — | Tiny Tytan Vent Tube Named without a submission number | |
| * | — | Reuter Bobbin Named without a submission number | |
| * | — | Collar Button Named without a submission number | |
| * | — | Spoon Bobbin Named without a submission number | |
| * | — | Shah Type Tube Named without a submission number | |
| * | — | T-Tubes Named without a submission number | |
| * | — | Beveled Bobbin Named without a submission number | |
| * | — | Shepard Grommets Named without a submission number |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071150 | Trocar Ventilation Tube/with Trocar Tip, Trocar Handle, Model 1015 074, 1015 076, 1015… | 2007 | 7 |
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?
- Of its descendants, K071150 (Heinz Kurz GmbH Medizintechnik, 2007) has gone furthest, with 7 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.
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?
Tympanic tubes are inserted into the eardrum (myringotomy) for drainage and temporary ventilation of the middle ear subsequent to acute otitis media. Tympanic tubes with one or two eyes are designed to increase the retention time in the eardrum. The substantially shortened passage of the DIABOLO reduces the length of the internal hollow cylinder and the smooth surface of the gold seems to diminish the risk of luminal occlusion. Placement: The tubes are…
Read the full statement (307 words)
Tympanic tubes are inserted into the eardrum (myringotomy) for drainage and temporary ventilation of the middle ear subsequent to acute otitis media.
Tympanic tubes with one or two eyes are designed to increase the retention time in the eardrum.
The substantially shortened passage of the DIABOLO reduces the length of the internal hollow cylinder and the smooth surface of the gold seems to diminish the risk of luminal occlusion.
Placement:
The tubes are placed in the tympanic membrane to provide the means for drainage of any fluid buildup in the middle ear while creating an avenue for the passage of air to equalize pressure on either side of the drum.
1. Temporary ventilation of the middle ear in serous otitis media in adult patients.
2. In cases of narrow meatus, atrophic drum or post tympanoplasty tube dysfunction. Due to its tiny size {Diameter 0.6 mm), insertion after tympanoplasty considerably reduces the risk of permanent perforation of the tympanum.
This tympanic ventilation tube, constructed of gold-plated stainless steel (1.4301), has been designed for temporary ventilation in special cases in which paracentesis alone is not sufficient, yet retention time of conventional tubes would be too long. The tube features a sharpened end that can be pushed through the tympanic membrane with alligator forceps without prior paracentesis.
If the effusion is somewhat thicker than expected, an additional small paracentesis beside the tube is recommended, via which the mucous tympanum can easily be aspirated due to the pressure balance which is achieved through the ventilation tube.
Should secretion encrustation occur, the MINIMAL Ventilation Tube can be replaced without the need for surface anaesthesia and without pain to the patient as it has no internal flange but is kept in position through tissue tension.
Placement:
Following surface anaesthesia, the tube is pushed through the tympanic membrane with alligator forceps without prior paracentesis.
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/K973226 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973226: Tubingen Tympanic Ventilation Tube, Tympanic Ventilation Tubes with Ene/S, Diabolo Tympanic Ventilation Tube, Minimal T).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973226
Report an extraction error
Are you the manufacturer?
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