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Vista 300/Vista 300 S - Vista 300 S Invasive Model C, US (2602427)

by Shanghai Draeger Medical Instrument Co., Ltd.

510(k) K252250

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K252250↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK252250 Date10 Apr 2026ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
MHX
Models / Variants
Vista 300 S Invasive Model C, US (2602427)
Device Class
Class II
Regulation
21 CFR Part 870.1025
Advisory Committee
Cardiovascular
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 Vista 300/Vista 300 S is a physiological patient monitor designed for arrhythmia detection and alarm capabilities. It continuously monitors vital signs, including cardiac rhythm, to identify abnormal heart rhythms and trigger alerts for clinical intervention.

These devices are intended for use in clinical settings such as hospitals and intensive care units. Supplied as reusable medical equipment, they require sterilisation between uses and comply with MRI safety standards for non-ferrous materials. Each model variant (non-invasive or invasive) is authorised under FDA 510K and MDR regulations, with specific model numbers and reference codes ensuring traceability and regulatory compliance.

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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 environments is the Vista 300/Vista 300 S designed for, and how does its arrhythmia detection feature benefit patients in those settings?

    The Vista 300/Vista 300 S is specifically designed for use in clinical settings like hospitals and intensive care units, where continuous cardiac monitoring is critical. Its primary function is to detect abnormal heart rhythms (arrhythmias) and trigger alarms to alert clinicians, enabling timely intervention. This is particularly valuable in high-acuity environments where rapid response to cardiac events can significantly impact patient outcomes.

  • Are the Vista 300/Vista 300 S models reusable, and if so, what sterilization requirements apply?

    Yes, the Vista 300/Vista 300 S models are reusable medical devices. Since they are intended for repeated use, they must undergo proper sterilization between patients to ensure safety and prevent cross-contamination. The manufacturer’s instructions should be followed for the specific sterilization method, though the device is designed to comply with standard sterilization protocols.

  • How do the non-invasive and invasive model variants differ, and which ones are authorized under FDA 510K and MDR?

    The Vista 300/Vista 300 S comes in both non-invasive and invasive model variants, differentiated by their intended use (e.g., Model A for non-invasive monitoring vs. Models B or C for invasive applications). All variants—including the Vista 300 Non-Inv Model A (2601064), Invasive Model C (2601065), Vista 300 S Non-Inv Model A (2602425), and the invasive S models (2602426, 2602427)—are authorized under both FDA 510K and MDR regulations, ensuring compliance with global standards.

  • What safety considerations should clinicians keep in mind when using the Vista 300/Vista 300 S, particularly regarding MRI compatibility?

    The Vista 300/Vista 300 S is designed with MRI safety in mind, specifically using non-ferrous materials to ensure it can be safely used in MRI environments. Clinicians should verify compatibility with their facility’s MRI protocols and follow manufacturer guidelines to avoid interference or safety risks during imaging procedures.

  • How can I verify the regulatory compliance of a specific Vista 300/Vista 300 S model before purchasing?

    Each model variant has unique reference codes (e.g., 2601064 for Vista 300 Non-Inv Model A) and is authorized under both FDA 510K and MDR. To confirm compliance, check the model number and its corresponding registration number (e.g., 3021219789) against the manufacturer’s documentation or regulatory databases. This ensures the device meets required standards for its intended use.