Product code PMS— General Hospital

ivWatch Model 400

Classification name: Peripheral Intravenous (Piv) Infiltration Monitor
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Total cleared: 5
First cleared: 2016-02-11
Most recent: 2024-03-15

FDA classification definition

“Peripheral catheter monitor (PIV) indicated for the detection of subcutaneous infiltrations and extravasations.”
— U.S. Food and Drug Administration, device classification record for product code PMS under 21 CFR 880.5725, via openFDA

Market context for product code PMS

FDA has cleared 5 devices under product code PMS between 2016 and 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20241 clearance
20221 clearance
20201 clearance
20162 clearances

Top applicants under product code PMS

Ivwatch, LLC5 clearances

Recent clearances under product code PMS

K233881 — ivWatch® Model 400Ivwatch, LLC·2024-03-15
K222212 — ivWatch Model 400Ivwatch, LLC·2022-08-24
K192385 — ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient CableIvwatch, LLC·2020-07-02
K162478 — ivWatchIvwatch, LLC·2016-12-22
K153605 — ivWatch Model 400Ivwatch, LLC·2016-02-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.