510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PMSClass II

Peripheral Intravenous (Piv) Infiltration Monitor

21 CFR 880.5725 / General Hospital
FDA source (opens on fda.gov)

PMS is the FDA product code for Peripheral Intravenous (Piv) Infiltration Monitor, a class II device type, regulated under 21 CFR 880.5725. FDA's definition for this code reads: "Peripheral catheter monitor (PIV) indicated for the detection of subcutaneous infiltrations and extravasations". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PMS
Device name
Peripheral Intravenous (Piv) Infiltration Monitor
FDA definition
Peripheral catheter monitor (PIV) indicated for the detection of subcutaneous infiltrations and extravasations.
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code PMS

By decision year
5 clearances under product code PMS with a decision year between 2016 and 2024, 2016 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PMS by decision year
YearClearances
20162
20201
20221
20241

Applicants with the most clearances

Product code PMS
Applicants holding the most 510(k) clearances under product code PMS
ApplicantClearances
Ivwatch, LLC5

Companies listing this code with FDA

Companies whose registered establishments list this code