Skip to content

Medical Magnetic Tape Recorder

by Wpr Medical AS

510(k) K102111

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 · Traditional NumberK102111 Date7 Dec 2010ClearedStatusActive

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  • Withdrawn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
DSI
Device Class
Class II
Regulation
21 CFR Part 870.1025
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

A Detector and Alarm for Arrhythmia (per FDA nomenclature), this device records and stores cardiac electrical signals on magnetic tape. It is designed to detect and alert clinicians to arrhythmias by capturing continuous electrocardiogram (ECG) data for later analysis.

Used primarily in cardiac monitoring settings, this device is intended for single-use or reusable applications depending on manufacturer specifications. It operates under FDA 510(k) clearance (K102111) and falls under Regulation 870.1025, classified as Class II. No MRI safety or sterility details are provided in the data.

Questions

AI-generated answers, 19 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 is the primary purpose of the Medical Magnetic Tape Recorder in clinical settings?

    The Medical Magnetic Tape Recorder is designed to detect and alert clinicians to arrhythmias by continuously recording and storing cardiac electrical signals on magnetic tape. It captures electrocardiogram (ECG) data for later analysis, making it useful in cardiac monitoring environments where real-time arrhythmia detection is critical.

  • How is the device classified under FDA regulations, and what does this classification imply?

    The device is classified as Class II under FDA regulation 870.1025, which means it is subject to special controls to ensure its safety and effectiveness. This classification implies that it requires premarket notification (510(k)) clearance, as evidenced by its FDA 510(k) clearance (K102111), and is intended for moderate-risk medical use.

  • Is the Medical Magnetic Tape Recorder intended for single-use or reusable applications?

    The device is designed for either single-use or reusable applications, depending on the manufacturer’s specifications. This flexibility allows healthcare facilities to choose based on their operational needs, infection control protocols, and cost considerations.

  • What regulatory route was followed for the FDA clearance of this device?

    The Medical Magnetic Tape Recorder received FDA clearance through a traditional 510(k) pathway, which involves demonstrating that the device is substantially equivalent to a legally marketed predicate device. The clearance was granted on December 7, 2010, after review by the Cardiovascular (CV) Advisory Committee.

  • Are there any specific details about the device’s compatibility with other systems or environments?

    The provided data does not specify compatibility with MRI environments or sterility requirements, so users should confirm these details with the manufacturer. However, the device is primarily intended for cardiac monitoring settings where continuous ECG data capture is necessary.