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))
FDA 510(k) clearance K250256 · decided 2025-04-28
Clearance details
- K-number
- K250256
- Device name
- 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))
- Applicant
- Aventamed Dac
- Decision
- Substantially Equivalent
- Date received
- 2025-01-28
- Decision date
- 2025-04-28
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- ETD
- Device class
- 2
- Regulation number
- 874.3880
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Bishopstown, IE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Tula Tympanostomy Tube Delivery Device (K252436) | Tusker Medical, Inc. | 2026-04-23 |
| Solo+ Tympanostomy Tube Device (TTD) (K232702) | Aventamed Dac | 2024-05-20 |
| Biowy Tym Tube (TT) (K233658) | Biowy Corporation | 2024-02-16 |
| Tympanostomy Tubes (K232059) | Grace Medical, Inc. | 2023-11-24 |
| Hummingbird Tympanostomy Tube System (K221254) | Preceptis Medical, Inc. | 2022-07-27 |
| Hummingbird Tympanostomy Tube System (K200952) | Preceptis Medical, Inc. | 2020-06-05 |
| TULA Tube Delivery System (K171239) | Tusker Medical | 2017-06-28 |
| Hummingbird Tympanostomy Tube (K151830) | Preceptis Medical | 2015-09-21 |
| Ventilation (Tympanostomy) Tubes (K151067) | Medtronic Xomed, Inc. | 2015-07-22 |
| HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS) (K142282) | Preceptis Medical | 2015-04-23 |
| PRECEPTIS TYMPANOSTOMY TUBE INSERTER (K133921) | Preceptis Medical | 2014-08-22 |
| ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM (K103595) | Acclarent, Inc. | 2011-04-01 |
Recalls involving this device
No recalls on record reference this clearance.