510(k) · Cleared
Recalled · Class II · 2024Neozoline Ventilation Tubes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adept Medical, Ltd. · ETD Tube, Tympanostomy
Cleared on Jul 12, 2006 after an 86-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 7 times.
- Decided
- Jul 12, 2006
- Review
- 86 days
- Class
- Class II
- Product code
- ETD
- Recalls
- 7
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 24, 2024 | Class II | Z-0968-2025 | Device Design | Lack of 510(k) clearance. |
| Nov 24, 2024 | Class II | Z-0969-2025 | Device Design | Lack of 510(k) clearance. |
| Nov 24, 2024 | Class II | Z-0965-2025 | Device Design | Lack of 510(k) clearance. |
| Nov 24, 2024 | Class II | Z-0966-2025 | Device Design | Lack of 510(k) clearance. |
| Nov 24, 2024 | Class II | Z-0967-2025 | Device Design | Lack of 510(k) clearance. |
| Nov 24, 2024 | Class II | Z-0963-2025 | Device Design | Lack of 510(k) clearance. |
| Nov 24, 2024 | Class II | Z-0970-2025 | Device Design | Lack of 510(k) clearance. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
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?
The largest patient population are children between 4 months and 6 years of age (but not exclusively). Otological ventilation tubes are indicated for patients with:
- Chronic or recurrent otitis media with persistent effusion (OME).
- Recurrent acute otitis media.
- Acute otitis media with complications.
- Eustachian tube dysfunction resulting in one or more of the following: significant and symptomatic hearing loss, otalgia, vertigo, and tinnitus.
- Hearing loss resulting from bilateral chronic middle ear effusion.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K061058 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061058: Neozoline Ventilation Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061058
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026