PMS
- Product code
- PMS
- Device name
- Peripheral Intravenous (Piv) Infiltration Monitor
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5725
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 0 (direct download)
- 510(k) clearances (all years, FDA)
- 5 (all years; only the last 3 years are listed here)
FDA classification definition
Peripheral catheter monitor (PIV) indicated for the detection of subcutaneous infiltrations and extravasations.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K233881 | 2024-03-15 | Ivwatch, LLC | ivWatch® Model 400 | FDA |
Official FDA classification page: PMS
Classification and pathway per current FDA publications. Data from openFDA (CC0).