510(k) · Cleared
ClearedTympanostomy Tubes
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 Nov 24, 2023 as substantially equivalent to K062385 (Grace Medical, Inc., 2006) and 1 other predicate after a 136-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Nov 24, 2023
- Review
- 136 days
- Class
- Class II
- Product code
- ETD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K943325 (1994). 4 ancestors in all, the oldest K830228 (1983). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K943325 | Tympanostomy Tube | Grace Medical, Inc. | 1994 | — |
| −1 | K062385 | Blue Ptfe (Fluoroplastic) Ventilation Tubes | Grace Medical, Inc. | 2006 | — |
| 0 (this device) | K232059 | Tympanostomy Tubes | Grace Medical, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1999 | 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 |
|---|---|---|---|
| * | K062385 | Blue Ptfe (Fluoroplastic) Ventilation TubesSummary page 4…COMMON NAME: ETFE Tympanostomy Tube PROPRIETARY NAME: Tympanostomy Tube PREDICATE DEVICES: Grace Medical, Inc. PTFE Tympanostomy Tube (K062385) and Micromedic, Inc. ETFE Tympanostomy Tube (K830228) CLASSIFICATION NAME: 21 CFR… | 2006 |
| * | K830228 | Otological Ventilation Tubes-VariousSummary page 4…tomy Tube PREDICATE DEVICES: Grace Medical, Inc. PTFE Tympanostomy Tube (K062385) and Micromedic, Inc. ETFE Tympanostomy Tube (K830228) CLASSIFICATION NAME: 21 CFR § 874.3880 PRODUCT CODES: ETD DEVICE CLASS:… | 1983 |
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?
- The line of descent spans 29 years and passes through 1 company; a new generation was cleared every 17.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All ETD devicesETD Tube, Tympanostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
1) Chronic otitis media with effusion characterize as either serous, mucoid, or purulent.
2) Recurrent acute otitis media which fails to respond satisfactorily to alternative therapies.
3) A patient with a history of persistent high negative middle ear pressure which may be associated with conductive hearing loss that is symptomatic, persistent or recurrent otalgia, persistent or recurrent vertigo and/or tinnitus.
4) Atelectasis recurrent form retraction pocket of the tympanic membrane or eustachian tube dysfunction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232059 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232059: Tympanostomy Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232059
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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