XSTAT P15
FDA 510(k) clearance K253290 · decided 2025-11-12
Clearance details
- K-number
- K253290
- Device name
- XSTAT P15
- Applicant
- Revmedx, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-29
- Decision date
- 2025-11-12
- Days to decision
- 44 days
- Clearance type
- Traditional
- Product code
- PGZ
- Device class
- 2
- Regulation number
- 878.4452
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Wilsonville, OR, US
- 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 |
|---|---|---|
| XSTAT 30 Pouch (K210676) | Revmedx, Inc. | 2021-08-27 |
| XSTAT 30, 1-Pack (K180051) | Revmedx, Inc. | 2018-05-18 |
| XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack (K170334) | Revmedx, Inc. | 2017-05-01 |
| XSTAT-12, 3-Pack, XSTAT-12, 1-Pack (K161020) | Revmedx, Inc. | 2016-07-28 |
| XSTAT 30, 3-PACK, XSTAT 30, 1-PACK (K152624) | Revmedx, Inc. | 2015-12-07 |
| XSTAT (DEN130016) | Revmedx, Inc. | 2014-04-03 |
Recalls involving this device
No recalls on record reference this clearance.