510(k) Report

FDA applicant

Ivwatch, LLC

Newport News, VA6 decisions2015–20240 recalls

FDA records 6 decisions for Ivwatch, LLC (Newport News, VA) from 2015 to 2024: 6 510(k) clearances. Most are in product codes PMS (Peripheral Intravenous (Piv) Infiltration…) and MRZ (Accessories, Pump, Infusion). Its devices cite 6 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Ivwatch, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2015: 12016: 22020: 12022: 12024: 1
2015high 2 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Ivwatch, LLC by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PMSPeripheral Intravenous (Piv) Infiltration Monitor5decisions
  • MRZAccessories, Pump, Infusion1decision

Whose devices does it build on?

Its devices cite 6 predicates; 5 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K162478ivWatchIvwatch, LLC · 20162cite it
  • K153605ivWatch Model 400Ivwatch, LLC · 20161cites it
  • K142374ivWatch Model 400Ivwatch, LLC · 20151cites it
  • K192385ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient CableIvwatch, LLC · 20201cites it

What has FDA decided for it 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
  • K142374ivWatch Model 400Ivwatch, LLC · 2015

All 6 as Ivwatch, LLC →