510(k) · Cleared
ClearedBlue Ptfe (Fluoroplastic) Ventilation 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 Sep 27, 2006 as substantially equivalent to K992222 (Gyrus Ent LLC, 1999) and 1 other predicate after a 43-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Sep 27, 2006
- Review
- 43 days
- Class
- Class II
- Product code
- ETD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K943325 (1994). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K232059Tympanostomy TubesGrace Medical, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943325 | Tympanostomy Tube | Grace Medical, Inc. | 1994 | — |
| 0 (this device) | K062385 | Blue Ptfe (Fluoroplastic) Ventilation Tubes | Grace Medical, Inc. | 2006 | — |
| +1 | K232059 | Tympanostomy Tubes | Grace Medical, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K992222 | Fluoroplastic Ventilation TubesSummary page 1…Manufacturer (if known) Fluoroplastic Ventilation Tubes Gyrus ENT K992222 Tympanostomy Tubes Grace Medical Inc. K943325 Intended Use -… | 1999 |
| * | K943325 | Tympanostomy TubeSummary page 1…Gyrus ENT K992222 Tympanostomy Tubes Grace Medical Inc. K943325 Intended Use - The Grace Medical Blue PTFE (Fluoroplastic) Ventilation Tubes have the same primary intended use as the predicat… | 1994 |
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 |
|---|---|---|---|
| K232059 | Tympanostomy Tubes | 2023 | 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K232059 (Grace Medical, Inc., 2023) 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?
Chronic otitis media with effusion (serous, mucoid, or purulent)
Recurrent episodes of acute otitis media despite conventional medical treatment
A record of persistent high negative middle ear pressure associated with one or more of the following system:
1. Conductive hearing loss that is symptomatic
2. Persistent or recurrent otalgia
3. Persistent or recurrent vertigo, tinnitus, or both
Atelectasis resultant from retraction pocket of the tympanic membrane or eustachian tube dysfunction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062385 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062385: Blue Ptfe (Fluoroplastic) Ventilation Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062385
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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