Device class
Class II
Regulation 874.3880
Total clearances
7
2020-06-05 → 2026-04-23
Classification details
Medical specialty
Ear, Nose, Throat
Regulation number
874.3880
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Aventamed Dac |
2 |
0 |
2025-04-28 |
|
Preceptis Medical, Inc. |
2 |
0 |
2022-07-27 |
|
Tusker Medical, Inc.
|
1 |
1 |
2026-04-23 |
|
Grace Medical, Inc. |
1 |
0 |
2023-11-24 |
|
Biowy Corporation |
1 |
0 |
2024-02-16 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 69433 |
CPT
|
— |
High
|
CPT code for insertion of tympanostomy tube(s) |
| A4612 |
HCPCS
|
Battery cables; replacement for patient-owned ventilator ✓ CMS-verified description |
Medium
|
HCPCS supply code for tympanostomy tube |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-04-23 |
K252436 |
Tusker Medical, Inc.
|
Tula Tympanostomy Tube Delivery Device |
| 2025-04-28 |
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)) |
| 2024-05-20 |
K232702 |
Aventamed Dac
|
Solo+ Tympanostomy Tube Device (TTD) |
| 2024-02-16 |
K233658 |
Biowy Corporation
|
Biowy Tym Tube (TT) |
| 2023-11-24 |
K232059 |
Grace Medical, Inc.
|
Tympanostomy Tubes |
| 2022-07-27 |
K221254 |
Preceptis Medical, Inc.
|
Hummingbird Tympanostomy Tube System |
| 2020-06-05 |
K200952 |
Preceptis Medical, Inc.
|
Hummingbird Tympanostomy Tube System |