PMS
5 FDA 510(k) clearances · Product code
98 daysmedian time to decision
303 days90th percentile
5clearances measured
FDA profile
- Official device name
- Peripheral Intravenous (Piv) Infiltration Monitor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Medical specialty
- General Hospital
- FDA definition
- Peripheral catheter monitor (PIV) indicated for the detection of subcutaneous infiltrations and extravasations.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ivWatch® Model 400 (K233881) | Ivwatch, LLC | 2024-03-15 |
| ivWatch Model 400 (K222212) | Ivwatch, LLC | 2022-08-24 |
| ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable (K192385) | Ivwatch, LLC | 2020-07-02 |
| ivWatch (K162478) | Ivwatch, LLC | 2016-12-22 |
| ivWatch Model 400 (K153605) | Ivwatch, LLC | 2016-02-11 |
Track PMS automatically
Every clearance here is in the API, with alerts when new ones post.