PMS

Peripheral Intravenous (Piv) Infiltration Monitor

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-03-15.

NumberDecision dateApplicantDevice nameSummary
K2338812024-03-15Ivwatch, LLCivWatch® Model 400FDA
Official FDA classification page: PMS
Classification and pathway per current FDA publications. Data from openFDA (CC0).