510(k) · Cleared
ClearedOtomedics Soft Tympanostomy Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Otomedics Advanced Medical Technologies, Ltd. · ETD Tube, Tympanostomy
Cleared on Jun 22, 2007 as substantially equivalent to K852387 (Xomed, Inc., 1986) and 4 other predicates after a 56-day review. Its family tree reaches back 1 generation to 1978.
- Decided
- Jun 22, 2007
- Review
- 56 days
- Class
- Class II
- Product code
- ETD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K781257 (1978). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK781257 Ventilation Tube Sili. Sheppard TypeXomed, Inc. · 1978
- This deviceK071178 Otomedics Soft Tympanostomy TubeOtomedics Advanced Medical Technologies, Ltd. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K781257 | Ventilation Tube Sili. Sheppard Type | Xomed, Inc. | 1978 | — |
| 0 (this device) | K071178 | Otomedics Soft Tympanostomy Tube | Otomedics Advanced Medical Technologies, Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1995 | 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? (5)
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 |
|---|---|---|---|
| * | K852387 | Goode T-Tube White Silicone Tympanostomy TubeSummary page 2…edical device. The classification panel is the Prosthetic Devices Panel Predicate Device: The Otomedics Soft Tympanostomy Tube (SiT) is similar to Goode T-Tubes (K852387 Manufactured by Xomed, Inc.), the Touma II T-Tube (K941407 Xomed - Treace Inc), the Armstrong Grommet (K822375 Manufacture… | 1986 |
| * | K941407 | Tympanostomy (Ventilation) TubeSummary page 2…vices Panel Predicate Device: The Otomedics Soft Tympanostomy Tube (SiT) is similar to Goode T-Tubes (K852387 Manufactured by Xomed, Inc.), the Touma II T-Tube (K941407 Xomed - Treace Inc), the Armstrong Grommet (K822375 Manufactured by Xomed-Treace, Inc), the Straight Shank (510(k) K781257)… | 1995 |
| * | K822375 | Armstrong V Vent TubeSummary page 2…ympanostomy Tube (SiT) is similar to Goode T-Tubes (K852387 Manufactured by Xomed, Inc.), the Touma II T-Tube (K941407 Xomed - Treace Inc), the Armstrong Grommet (K822375 Manufactured by Xomed-Treace, Inc), the Straight Shank (510(k) K781257) Xomed Inc) and the Umbrella Tube (K791680 Xomed Inc) i… | 1982 |
| * | K781257 | Ventilation Tube Sili. Sheppard TypeSummary page 2…ed by Xomed, Inc.), the Touma II T-Tube (K941407 Xomed - Treace Inc), the Armstrong Grommet (K822375 Manufactured by Xomed-Treace, Inc), the Straight Shank (510(k) K781257) Xomed Inc) and the Umbrella Tube (K791680 Xomed Inc) in the intended use and in technological characteristics of the devices.… | 1978 |
| * | K791680 | Pope Umbrella TubeSummary page 2…41407 Xomed - Treace Inc), the Armstrong Grommet (K822375 Manufactured by Xomed-Treace, Inc), the Straight Shank (510(k) K781257) Xomed Inc) and the Umbrella Tube (K791680 Xomed Inc) in the intended use and in technological characteristics of the devices. Device Description: The Otomedics STT… | 1979 |
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?
- None of the 5 ancestors has a recall.
How does its category compare?
All ETD devicesETD Tube, Tympanostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Otomedics Soft Tympanostomy Tube is a device that is intended to be implanted for ventilation or drainage of the middle ear.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071178 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071178: Otomedics Soft Tympanostomy Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071178
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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