PMS — Peripheral Intravenous (Piv) Infiltration Monitor Class II
FDA product code PMS covers "Peripheral Intravenous (Piv) Infiltration Monitor", a Class II medical device regulated under 21 CFR 880.5725. Submissions are reviewed by the General Hospital panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PMS
- Device Class
- Class II
- Regulation Number
- 880.5725
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
Peripheral catheter monitor (PIV) indicated for the detection of subcutaneous infiltrations and extravasations.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233881 | ivwatch | ivWatch® Model 400 | March 15, 2024 |
| K222212 | ivwatch | ivWatch Model 400 | August 24, 2022 |
| K192385 | ivwatch | ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Pati | July 2, 2020 |
| K162478 | ivwatch | ivWatch | December 22, 2016 |
| K153605 | ivwatch | ivWatch Model 400 | February 11, 2016 |