510(k) · Cleared
ClearedExmoor Myringotomy Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exmoor Plastics, Ltd. · ETD Tube, Tympanostomy
Cleared on Oct 22, 1998 after a 233-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Oct 22, 1998
- Review
- 233 days
- Class
- Class II
- Product code
- ETD
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK980828 Exmoor Myringotomy KitExmoor Plastics, Ltd. · 1998
- Descendant · cites it directly · 1 of its ownK103595 Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery SystemAcclarent, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK171239 TULA Tube Delivery SystemTusker Medical · 2017
- Descendant · cites it directly · 0 of its ownK990366 Exmoor Suction Clearance KitExmoor Plastics, Ltd. · 1999
Most influential descendants
Showing 3 of 3 · See all- K103595Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery SystemAcclarent, Inc. · 2011 · cites it directly1descendant
- K171239TULA Tube Delivery SystemTusker Medical · 2017 · 2 generations on0descendants
- K990366Exmoor Suction Clearance KitExmoor Plastics, Ltd. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980828 | Exmoor Myringotomy Kit | Exmoor Plastics, Ltd. | 1998 | — |
| +1 | K103595 | Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery System | Acclarent, Inc. | 2011 | — |
| +2 | K171239 | TULA Tube Delivery System | Tusker Medical | 2017 | — |
| +1 | K990366 | Exmoor Suction Clearance Kit | Exmoor Plastics, Ltd. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 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? (2)
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 |
|---|---|---|---|
| * | — | Richards Set-Op Myringotomy Kit Named without a submission number | |
| * | — | Exmoor Tympanocentesis Kit Named without a submission number |
What descends from it? (3)
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?
- Of its descendants, K103595 (Acclarent, Inc., 2011) has gone furthest, with 1 descendant 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?
Requirement for myringotomy, with or without
the insertion of aural ventilation tube(s).
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/K980828 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980828: Exmoor Myringotomy Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980828
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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