510(k) Report

FDA product code · General hospital

Peripheral Intravenous (Piv) Infiltration Monitor

PMSClass II21 CFR 880.5725510(k) required5 decisions since 20160 recalls

5 FDA decisions since 2016. 510(k) reviews decided 2021–2025 took a median of 64 days (half between 47 and 81). No recall names this code. The most-cited predicate is K162478, named by 2 later devices.

Peripheral catheter monitor (PIV) indicated for the detection of subcutaneous infiltrations and extravasations.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, general hospital panel

Twenty years of PMS at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · PMS

1in 2024

2016: 22020: 12022: 12024: 1
2007high 2 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PMS

Too few PMS 510(k)s in any year since 2007 to give a median.

Recalls per year · PMS

No recall names PMS since 2007.

Adverse event reports per year · PMS

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2025

MAUDE reports naming product code PMS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20162—00
20170—00
20180—00
20190—00
20201—00
20210—00
20221—01
20230—00
20241—00
20250—00
20260—0—
FIG. 1 — PMS by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PMS? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do PMS devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K162478ivWatchIvwatch, LLC · 20162cite it
  • K153605ivWatch Model 400Ivwatch, LLC · 20161cites it
  • K192385ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient CableIvwatch, LLC · 20201cites it

Which PMS devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K233881ivWatch® Model 400Ivwatch, LLC · 20249generations
  • K222212ivWatch Model 400Ivwatch, LLC · 20228generations
  • K192385ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient CableIvwatch, LLC · 20208generations
  • K162478ivWatchIvwatch, LLC · 20167generations
  • K153605ivWatch Model 400Ivwatch, LLC · 20166generations

What has FDA decided in PMS lately?

  • K233881ivWatch® Model 400Ivwatch, LLC · 2024
  • K222212ivWatch Model 400Ivwatch, LLC · 2022
  • K192385ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient CableIvwatch, LLC · 2020
  • K162478ivWatchIvwatch, LLC · 2016
  • K153605ivWatch Model 400Ivwatch, LLC · 2016

All 5 PMS decisions →

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