510(k) · Cleared
ClearedHoffman H/a Coated Long-Term Ventilation Tube with Liner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Xomed · ETD Tube, Tympanostomy
Cleared on Feb 11, 1997 as substantially equivalent to K900267 (Smith & Nephew Richards, Inc., 1990) after a 148-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.
- Decided
- Feb 11, 1997
- Review
- 148 days
- Class
- Class II
- Product code
- ETD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K900267 (1990). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K151067Ventilation (Tympanostomy) TubesMedtronic Xomed, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900267 | Jahn Ventilation Tube | Smith & Nephew Richards, Inc. | 1990 | — |
| 0 (this device) | K963727 | Hoffman H/a Coated Long-Term Ventilation Tube with Liner | Medtronic Xomed | 1997 | — |
| +1 | K151067 | Ventilation (Tympanostomy) Tubes | Medtronic Xomed, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (3)
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 |
|---|---|---|---|
| * | K900267 | Jahn Ventilation TubeSummary page 2…on tubes are as follows: Xomed Silverstein Permanent Aeration Tube (SPAT) (Preamendment) [Xomed Surgical Products, Inc] Jahn Hydroxylvent™ Tube w/ fluoroplastic liner (K900267) [Smith & Nephew/Richards] Fluoroplastic/Titanium Ventilation Tubes (Unknown) [Smith & Nephew/Richards] 035 | 1990 |
| * | — | Xomed Silverstein Permanent Aeration Tube (SPAT) Named without a submission number | |
| * | — | Fluoroplastic/Titanium Ventilation Tubes Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151067 | Ventilation (Tympanostomy) Tubes | 2015 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K151067 (Medtronic Xomed, Inc., 2015) has gone furthest, with 0 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?
The Xomed Hoffman H/A Coated Long-Term Ventilation Tube with Liner is intended for prescription use only, as a means of communication of the outer and middle ear to provide long-term ventilation or drainage of the middle ear when inserted under the tympanic membrane.
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/K963727 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963727: Hoffman H/a Coated Long-Term Ventilation Tube with Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963727
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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