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Tonoport V

by Par Medizintechnik GmbH

510(k) K012647

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Abbreviated NumberK012647 Date9 Nov 2001ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXN
Device Class
Class II
Regulation
21 CFR Part 870.1130
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Tonoport V is a portable ambulatory blood pressure monitoring device designed for non-invasive measurement and recording of blood pressure over extended periods. It falls under the category of cardiovascular monitoring systems, enabling automated, scheduled or random interval measurements to assess hypertension or other cardiovascular conditions. The device processes and displays results in a clear, user-friendly format for immediate clinical assessment.

Supplied as a reusable medical device, the Tonoport V is intended for use in clinical, home, or ambulatory settings where continuous or periodic blood pressure monitoring is required. It connects to a PC for data transfer and integration into healthcare information systems, with measurements saved for later analysis. Authorized under FDA 510(k) clearance (K012647) as substantially equivalent, the device adheres to regulatory standards for cardiovascular monitoring equipment. No specific sterility or MRI safety information is provided in the available data.

Questions

AI-generated answers, 1 Oct 2026

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

  • What is the Tonoport V used for?

    The Tonoport V is designed for non-invasive, extended monitoring of blood pressure in clinical, home, or ambulatory settings. It automates scheduled or random interval measurements to help assess hypertension or other cardiovascular conditions. The device provides immediate, clear results for clinical assessment and stores data for later analysis.

  • Is the Tonoport V a single-use or reusable device?

    The Tonoport V is a reusable medical device. It is intended for repeated use in various settings, including hospitals, clinics, or patient homes, where continuous or periodic blood pressure monitoring is required.

  • How does the Tonoport V connect to other systems?

    The Tonoport V connects to a PC for data transfer, allowing integration with healthcare information systems. This enables clinicians to save measurements for detailed analysis and review.

  • What regulatory clearance does the Tonoport V hold?

    The Tonoport V holds FDA 510(k) clearance (K012647) as substantially equivalent to a predicate device. This clearance confirms it meets regulatory standards for cardiovascular monitoring equipment under the FDA’s abbreviated review process.

  • Does the Tonoport V require special storage or handling?

    The available data does not specify any special sterility or storage requirements for the Tonoport V. However, as a reusable device, it should be cleaned and maintained according to standard medical device protocols to ensure accuracy and hygiene.