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DataCaptor

by Capsule Technologie 2 variants

510(k) K013019

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK013019 Date18 Dec 2001ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2377-2012 FDA Class II initiated 10 Aug 2012

    Capsule Neuron Docking Station may experience a lost connection, resulting in loss of data or loss of power to the Caspsule Neuron

    • Terminated Z-2403-2011 FDA Unclassified (pre-2012) initiated 25 Aug 2010

    Software: Data cached on the Neuron due to server unavailability is not being delivered to the server after server availability is restored. If a compact flash failure occurs, the file system may be corrupted and result in system hangs, lock-ups or crashes. Batteries can discharge completely in a Capsule Neuron" UMPC even though it is connected to power source

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  • Withdrawn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
MWI
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 DataCaptor is a Class 2 Cardiovascular device with product code MWI. It is used for medical device integration and data collection. The device enables local processing of data collected from medical devices.

The DataCaptor is supplied with DataCaptor Connectivity software, which runs locally on Capsule Neurons in continuous or periodic data collection mode. It has FDA 510K authorization and is cleared through the Traditional 510K pathway.

Other devices from Capsule Technologie

See all devices from Capsule Technologie →

Questions

AI-generated answers, 26 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 DataCaptor used for?

    The DataCaptor is used for medical device integration and data collection, enabling local processing of data from medical devices.

  • How is the DataCaptor supplied?

    The DataCaptor is supplied with DataCaptor Connectivity software, which runs locally on Capsule Neurons in continuous or periodic data collection mode.

  • What type of authorization does the DataCaptor have?

    The DataCaptor has FDA 510K authorization, cleared through the Traditional 510K pathway, indicating it is substantially equivalent to a predicate device.