Otological Ventilation Tubes-Various
510(k) K830228
Otological Ventilation Tubes-Various is a medical device (FDA Class II; FDA product code ETD, Tube, Tympanostomy) made by Micromedics, Inc., cleared under FDA 510(k) K830228 on 7 Mar 1983, active as of 10 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK830228 | Date7 Mar 1983 | StatusActive |
Official records
- FDA 510(k) database K830228
Recalls
-
- Terminated Z-1731-2014
One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventilation tubes with wire attached to the straight flange. This poses no health hazard to the user or patient.
Timeline
- Cleared FDA 510(k) K830228
- Recall initiated FDA recalls Z-1731-2014
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ETD
- Device class
- Class II
- Regulation
- 21 CFR Part 874.3880
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K830228
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| 0205003 | 0205003 | 00385640026079 | — | On the market |
| 0205005 | 0205005 | 00385640020541 | — | On the market |
| POPE VENT TUBE 530-003 | 530-003 | 00844505008525 | — | On the market |
| SM-40014 | SM-40014 | 00385640024082 | — | On the market |
| SM-40036 | SM-40036 | 00385640024099 | — | On the market |
| SM-40075 | SM-40075 | 00385640028806 | — | On the market |
| SM-40242 | SM-40242 | 00385640024105 | — | On the market |
| SM-45208 | SM-45208 | 00385640028790 | — | On the market |
| Summit Medical VT-0100-01 | VT-0100-01 | 00385640068796 | — | On the market |
| Summit Medical VT-0204-01 | VT-0204-01 | 00385640068628 | — | On the market |
| Summit Medical VT-0401-01 | VT-0401-01 | 00385640068857 | — | On the market |
| Summit Medical VT-0501-01 | VT-0501-01 | 00385640068635 | — | On the market |
| Summit Medical VT-0602-01 | VT-0602-01 | 00385640068666 | — | On the market |
| Summit Medical VT-1203-01 | VT-1203-01 | 00385640068727 | — | On the market |
| SUPERSOFT™ T-TUBE 510-361 | 510-361 | 00844505012621 | — | On the market |
| TE-7011-CE | TE-7011-CE | 00385640022354 | — | On the market |
| TE-7091-CE | TE-7091-CE | 00385640022873 | — | On the market |
| VC-49001 | VC-49001 | 00385640023030 | — | On the market |
| VC-49007 | VC-49007 | 00385640023092 | — | On the market |
| VC-49055 | VC-49055 | 00385640040358 | — | On the market |
| VC-49144 | VC-49144 | 00385640023573 | — | On the market |
| VT-003-01-E | VT-003-01-E | 00385640026710 | — | On the market |
| VT-0200-01 | VT-0200-01 | 00385640000581 | — | No longer on the market |
| VT-0202-01 | VT-0202-01 | 00385640000628 | — | No longer on the market |
| VT-0203-01-E | VT-0203-01-E | 00385640026628 | — | On the market |
| VT-0301-01 | VT-0301-01 | 00385640001038 | — | No longer on the market |
| VT-0310-50 | VT-0310-50 | 00385640001052 | — | No longer on the market |
| VT-0401-01 | VT-0401-01 | 00385640001083 | — | No longer on the market |
| VT-0401-01-P | VT-0401-01-P | 00385640027205 | — | No longer on the market |
| VT-0401-50 | VT-0401-50 | 00385640001090 | — | No longer on the market |
| VT-0405-50 | VT-0405-50 | 00385640001137 | — | On the market |
| VT-0409-50 | 1 / VT-0409-50 | 00385640001212 | — | On the market |
| VT-0503-01 | VT-0503-01 | 00385640001304 | — | No longer on the market |
| VT-0507-50 | VT-0507-50 | 00385640001335 | — | No longer on the market |
| VT-0509-01 | VT-0509-01 | 00385640001366 | — | On the market |
| VT-0509-50 | VT-0509-50 | 00385640001373 | — | No longer on the market |
| VT-0603-50 | VT-0603-50 | 00385640001410 | — | No longer on the market |
| VT-0608-50 | VT-0608-50 | 00385640001472 | — | No longer on the market |
| VT-0805-02 | VT-0805-02 | 00385640001618 | — | On the market |
| VT-0901-01 | VT-0901-01 | 00385640001670 | — | No longer on the market |
| VT-1001-50 | VT-1001-50 | 00385640001816 | — | No longer on the market |
| VT-1002-01 | VT-1002-01 | 00385640001823 | — | No longer on the market |
| VT-1011-50 | VT-1011-50 | 00385640001854 | — | No longer on the market |
| VT-1202-02 | VT-1202-02 | 00385640001991 | — | On the market |
| VT-1202-50 | VT-1202-50 | 00385640002004 | — | No longer on the market |
| VT-1203-01 | VT-1203-01 | 00385640002011 | — | No longer on the market |
| VT-1204-01 | VT-1204-01 | 00385640002035 | — | No longer on the market |
| VT-1206-01 | VT-1206-01 | 00385640002073 | — | On the market |
| VT-1214-01 | VT-1214-01 | 00385640002141 | — | No longer on the market |
| VT-1230-50 | VT-1230-50 | 00385640002233 | — | No longer on the market |
Similar devices
Other devices filed under FDA product code ETD (Tube, Tympanostomy).
- GYRUS ACMI 70241314 by Gyrus Acmi, Inc.
- GYRUS ACMI 70145498 by Gyrus Acmi, Inc.
- TYMPOVENT by Atos Medical AB
- BOBBIN STYLE VENTURI VENT TUBE by Micromed Development Corp.
- C-FLEX VENT TUBES by Micromed Development Corp.
- JAHN VENTILATION TUBE by Smith & Nephew Richards, Inc.
- TYMPANOSTOMY (VENTILATION) TUBE by Xomed-Treace, Inc.
- Neozoline Ventilation Tubes by Adept Medical Ltd
- Ventilation (Tympanostomy) Tubes by Medtronic Xomed Inc
- PFLEIDERER'S INTRATYMPANIC CATHETER by Exmoor Plastics Limited