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ivWatch (400 +3 more) - SmartTouch Sensor

by Ivwatch, LLC

510(k) K192385

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K192385↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK192385 Date2 Jul 2020ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
PMS
Models / Variants
SmartTouch Sensor
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ivWatch Model 400 is a Peripheral Intravenous (PIV) Infiltration Monitor, designed to detect and alert clinicians to potential infiltration during intravenous therapy. This device continuously monitors fluid administration to reduce complications such as tissue damage or infection by providing real-time feedback on infusion integrity.

The system comprises the ivWatch Model 400, paired with an Extension Module, SmartTouch Sensor, and Patient Cable for connectivity. Supplied as a reusable device with single-use sensors, it operates in general hospital settings and complies with FDA 510(k) clearance under the Medical Devices Directive (MDD) and Medical Device Regulation (MDR). Storage and handling follow manufacturer guidelines to maintain sensor functionality and device performance.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical setting is the ivWatch Model 400 intended for, and how does it help reduce complications during IV therapy?

    The ivWatch Model 400 is designed for use in general hospital settings, where it continuously monitors peripheral intravenous (PIV) infusions to detect potential infiltration. By providing real-time feedback on infusion integrity, it helps clinicians prevent complications like tissue damage or infection, which can occur if fluid leaks into surrounding tissues.

  • Is the ivWatch Model 400 itself reusable, or are there single-use components that need replacement after each patient?

    The ivWatch Model 400 device itself is reusable, but it requires single-use sensors (the SmartTouch Sensor and Patient Cable) for each patient. These disposable components ensure accurate monitoring and maintain hygiene standards, while the core device can be reused across multiple patients.

  • What accessories are included with the ivWatch Model 400, and how do they work together?

    The system includes the ivWatch Model 400 monitor, an Extension Module (for connectivity), a SmartTouch Sensor (attached to the IV line), and a Patient Cable (to link the sensor to the monitor). The sensor detects changes in fluid flow or resistance, sending real-time data via the cable and extension module to the monitor, which then alerts clinicians if infiltration is detected.

  • How should the ivWatch Model 400 and its sensors be stored to ensure proper functionality?

    The manufacturer provides specific storage and handling guidelines to maintain sensor functionality and device performance. While exact instructions aren’t detailed here, proper storage typically involves keeping the reusable device in a clean, dry environment and ensuring single-use sensors are stored according to their packaging to prevent contamination or damage before use.

  • What regulatory pathways does the ivWatch Model 400 follow, and how does that affect its use in hospitals?

    The ivWatch Model 400 has received FDA 510(k) clearance under the Medical Devices Directive (MDD) and Medical Device Regulation (MDR), confirming it meets U.S. and EU safety standards for Class II medical devices. This clearance allows hospitals to use it for monitoring PIV infiltration in compliance with regulatory requirements, ensuring its reliability and traceability in clinical settings.