510(k) · Cleared
ClearedGrace Medical PC Coated Tympanostomy 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 Oct 24, 2006 as substantially equivalent to K943325 (Grace Medical, Inc., 1994) and 2 other predicates after a 46-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Oct 24, 2006
- Review
- 46 days
- Class
- Class II
- Product code
- ETD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K943325 (1994). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK943325 Tympanostomy TubeGrace Medical, Inc. · 1994
- This deviceK062672 Grace Medical PC Coated Tympanostomy TubesGrace Medical, Inc. · 2006
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) | K062672 | Grace Medical PC Coated Tympanostomy Tubes | Grace Medical, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 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 |
|---|---|---|---|
| * | K943325 | Tympanostomy TubeSummary page 1…Tm tympanostomy tubes marketed by Grace Medical, Inc. (1K943325 & K981575) and PC Coated Tymapanostomy Tubes (Pacific ) (K(00080 1) marketed by Gymus ENT. Intended Use - The Grace Medical PC C… | 1994 |
| * | K981575 | Tympanostomy TubeSummary page 1…Tm tympanostomy tubes marketed by Grace Medical, Inc. (1K943325 & K981575) and PC Coated Tymapanostomy Tubes (Pacific ) (K(00080 1) marketed by Gymus ENT. Intended Use - The Grace Medical PC Coated Tymp… | 1998 |
| * | K000801 | PC Coated Fluoroplastic Vent Tubes | 2000 |
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?
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K943325.
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?
(a) Chronic otitis media with effusion (serous, mucoid, or purulent).
(b) Recurrent episodes of acute otitis media despite conventional medical treatment.
(c) A record of persistent high negative middle ear pressure associated with one or more of the following symptoms:
(i) Conductive hearing loss that is symptomatic.
(ii) Persistent or recurrent otalgia.
(iii) Persistent or recurrent vertigo, tinnitus, or both.
(d) Retraction pocket of the tympanic membrane.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062672 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062672: Grace Medical PC Coated Tympanostomy Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062672
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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