Peripheral Intravenous (Piv) Infiltration Monitor
The Peripheral Intravenous (PIV) Infiltration Monitor (product code PMS) is a Class 2 general hospital device intended for the detection of subcutaneous infiltrations and extravasations associated with peripheral intravenous catheters, regulated under 880.5725. It requires 510(k) clearance and falls within the general hospital medical specialty. The device is not an implant and is not life-sustaining.
Research product code PMS in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- PMS
- Device Class
- FDA class 2
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
Definition
Peripheral catheter monitor (PIV) indicated for the detection of subcutaneous infiltrations and extravasations.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K233881 | ivWatch® Model 400 | Mar 15, 2024 | Substantially Equivalent | Ivwatch, LLC |
| K222212 | ivWatch Model 400 | Aug 24, 2022 | Substantially Equivalent | Ivwatch, LLC |
| K192385 | ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable | Jul 02, 2020 | Substantially Equivalent | Ivwatch, LLC |
| K162478 | ivWatch | Dec 22, 2016 | Substantially Equivalent | Ivwatch, LLC |
| K153605 | ivWatch Model 400 | Feb 11, 2016 | Substantially Equivalent | Ivwatch, LLC |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.