V10
510(k) K170497
V10 is a Class II device made by Mediana.CO.LTD, cleared under FDA 510(k) K170497 on 15 Dec 2017, active as of 22 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 | NumberK170497 | Date15 Dec 2017 | StatusActive |
Official records
- FDA 510(k) database K170497
Recalls
-
- Terminated Z-2441-2020
Failures were found in the temperature measurement function while in the predict mode.
Timeline
- Cleared FDA 510(k) K170497
- Recall initiated FDA recalls Z-2441-2020
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DXN
- FDA applicant
- Mediana Co., Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1130
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K170497
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 | |||
|---|---|---|---|---|
| Direct Supply AVSM2 | V10D-3PBCRU / AVSM2 | 18800003439420 | — | No longer on the market |
| Direct Supply AVSM2 | V10D-3XBCFU / AVSM2 | 18800003456809 | — | On the market |
| Direct Supply AVSM2 | V10D-3XBCRU / AVSM2 | 18800003439444 | — | No longer on the market |
| Direct Supply AVSM2 | V10D-3XBCZU / AVSM2 | 18800003439437 | — | No longer on the market |
| Direct Supply AVSM2 | V10D-3XBNFU / AVSM2 | 18800003456847 | — | On the market |
| Patient Monitor V10 | V10M-2PXCRU / V10 | 18800003407788 | — | On the market |
| Patient Monitor V10 | V10M-2PXCZU / V10 | 18800003407795 | — | On the market |
| Patient Monitor V10 | V10M-2PXNRU / V10 | 18800003407740 | — | On the market |
| Patient Monitor V10 | V10M-2PXNZU / V10 | 18800003407757 | — | On the market |
| Patient Monitor V10 | V10M-3PLNRU / V10 | 18800003408884 | — | On the market |
| Patient Monitor V10 | V10M-3PLNZU / V10 | 18800003408891 | — | On the market |
| Patient Monitor V10 | V10M-3PXCRU / V10 | 18800003408686 | — | On the market |
| Patient Monitor V10 | V10M-3PXCZU / V10 | 18800003408693 | — | On the market |
| Patient Monitor V10 | V10M-3XXCRU / V10 | 18800003408488 | — | On the market |
| Patient Monitor V10 | V10M-3XXCZU / V10 | 18800003408495 | — | On the market |
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