FDA product code ETD: Tube, Tympanostomy
ETD is the FDA product code for tube, tympanostomy. It is a Class II device, regulated under 21 CFR 874.3880 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 116 510(k) submissions under ETD, 6 in the last five years, from 49 different applicants. The average 510(k) review took 85 days (median 55); 177 days on average over the last three years. FDA has posted 14 recalls for ETD devices, 10 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tube, Tympanostomy |
| Device class | Class II |
| Regulation | 21 CFR 874.3880 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for ETD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 62 |
| 2020 | 1 | 57 |
| 2022 | 1 | 86 |
| 2023 | 1 | 136 |
| 2024 | 2 | 176 |
| 2025 | 1 | 90 |
| 2026 | 1 | 265 |
Compare with all 510(k) review times · Search every ETD clearance
Top ETD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Exmoor Plastics , Ltd. | 16 | 1998-10-22 |
| Xomed, Inc. | 13 | 1997-05-16 |
| Treace Medical, Inc. | 9 | 1983-11-22 |
| Grace Medical, Inc. | 5 | 2023-11-24 |
| Micromed Development Corp. | 5 | 1994-09-16 |
44 more applicants have ETD clearances. See the full list in Caduvo.
Most recent ETD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252436 | Tusker Medical, Inc. | Tula Tympanostomy Tube Delivery Device | 2026-04-23 | 265 |
| K250256 | Aventamed Dac | Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000)) | 2025-04-28 | 90 |
| K232702 | Aventamed Dac | Solo+ Tympanostomy Tube Device (TTD) | 2024-05-20 | 258 |
| K233658 | Biowy Corporation | Biowy Tym Tube (TT) | 2024-02-16 | 93 |
| K232059 | Grace Medical, Inc. | Tympanostomy Tubes | 2023-11-24 | 136 |
Recalls for ETD devices
14 product recalls in 7 recall events; 10 initiated in the last five years and 10 still open. Most recent: 2024-11-24.
| Year | Recalls |
|---|---|
| 2023 | 1 |
| 2024 | 9 |
Frequently asked questions
What is FDA product code ETD?
ETD is the FDA product code for tube, tympanostomy. It is a Class II device, regulated under 21 CFR 874.3880 and reviewed by the Ear, Nose and Throat panel.
What device class is ETD?
Class II, regulation 21 CFR 874.3880. Typical premarket route: 510(k).
How long does a 510(k) take for product code ETD?
Across 116 cleared submissions the average was 85 days from receipt to decision (median 55).
Which companies have the most ETD clearances?
Exmoor Plastics , Ltd. (16); Xomed, Inc. (13); Treace Medical, Inc. (9); Grace Medical, Inc. (5); Micromed Development Corp. (5).
Have ETD devices been recalled?
Yes: 14 product recalls across 7 recall events; the most recent began 2024-11-24.
Next steps
- Run an FDA pathway report with predicate devices for product code ETD
- Run a recall and safety report across every ETD manufacturer
- Watch product code ETD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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