510(k) · Cleared
ClearedTympanostomy Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Grace Medical, Inc. · ETD Tube, Tympanostomy
Cleared on Oct 11, 1994 after a 92-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Oct 11, 1994
- Review
- 92 days
- Class
- Class II
- Product code
- ETD
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK943325 Tympanostomy TubeGrace Medical, Inc. · 1994
- Descendant · cites it directly · 1 of its ownK062385 Blue Ptfe (Fluoroplastic) Ventilation TubesGrace Medical, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK232059 Tympanostomy TubesGrace Medical, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK062672 Grace Medical PC Coated Tympanostomy TubesGrace Medical, Inc. · 2006
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943325 | Tympanostomy Tube | Grace Medical, Inc. | 1994 | — |
| +1 | K062385 | Blue Ptfe (Fluoroplastic) Ventilation Tubes | Grace Medical, Inc. | 2006 | — |
| +2 | K232059 | Tympanostomy Tubes | Grace Medical, Inc. | 2023 | — |
| +1 | K062672 | Grace Medical PC Coated Tympanostomy Tubes | Grace Medical, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
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, K062385 (Grace Medical, Inc., 2006) 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 | — |
https://510kreport.com/device/K943325 · printed Nov 6, 2026
Cite this page
510(k) Report. “K943325: 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/K943325
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026