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 1 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
Cleared
Jul 02, 2020
ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable
Ivwatch, LLC
General Hospital
303d
Cleared
Dec 22, 2016
ivWatch
Ivwatch, LLC
General Hospital
107d
Cleared
Feb 11, 2016
ivWatch Model 400
Ivwatch, LLC
General Hospital
56d
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 1 in the prior period.