FDA Product Code PMS: Peripheral Intravenous (piv) Infiltration Monitor
Peripheral Catheter Monitor (piv) Indicated For The Detection Of Subcutaneous Infiltrations And Extravasations.
Leading manufacturers include Ivwatch, LLC.
5
Total
5
Cleared
119d
Avg days
2016
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Peripheral Intravenous (piv) Infiltration Monitor Devices (Product Code PMS)
5 devices
Cleared
Mar 15, 2024
ivWatch® Model 400
Ivwatch, LLC
General Hospital
98d
Cleared
Aug 24, 2022
ivWatch Model 400
Ivwatch, LLC
General Hospital
30d
About Product Code PMS - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code PMS since 2016, with 5 receiving FDA clearance (average review time: 119 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
PMS devices are reviewed by the General Hospital panel. Browse all General Hospital devices →