DataCaptor System
510(k) K113835
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK113835 | Date27 Jun 2012 | StatusActive |
Recalls
-
- Terminated Z-2377-2012
Capsule Neuron Docking Station may experience a lost connection, resulting in loss of data or loss of power to the Caspsule Neuron
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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, 19 Sep 2026
The DataCaptor System is a medical device classified under MWI (Medical Information Systems) for data collection and clinical information management. It facilitates communication and integration between bedside medical devices and hospital information systems, enabling centralized data aggregation without direct patient monitoring capabilities.
The system is supplied as a software-based solution, intended for use in healthcare settings such as hospitals. It is a reusable, non-sterile device with no specified MRI safety classification. Authorized under FDA 510(k) clearance (K113835), it operates as part of Capsule Tech’s Connectivity Suite, adhering to regulatory standards for medical information systems.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the DataCaptor System in a clinical setting?
The DataCaptor System is designed to serve as a medical information system (MWI) that bridges bedside medical devices with hospital information systems. It collects and aggregates clinical data centrally, enabling seamless communication between devices and IT infrastructure—though it does not perform direct patient monitoring itself.
Is the DataCaptor System reusable or single-use, and what does that mean for my facility?
The DataCaptor System is explicitly described as reusable, meaning it is not intended for single-patient use or disposal. Since it is a software-based solution, this classification applies to its hardware components (e.g., servers, interfaces) rather than consumables, allowing for long-term deployment in healthcare settings without replacement after each use.
Does the DataCaptor System require any special handling for sterility or compatibility with imaging equipment?
The system is non-sterile and does not have a specified MRI safety classification, so it can be used in environments where MRI compatibility is not a concern. Sterility is irrelevant for this software-based device, as it does not come into contact with patients or sterile fields.
How is the DataCaptor System supplied, and what does that mean for implementation in my hospital?
The DataCaptor System is supplied as a software-based solution as part of Capsule Tech’s Connectivity Suite. This means it requires installation on hospital servers or networks, integration with existing medical devices, and potentially IT support for setup and maintenance—unlike a plug-and-play hardware device.
What regulatory pathway was followed for the DataCaptor System’s FDA clearance, and what does that imply for compliance?
The system was cleared via a traditional 510(k) pathway (K113835) under the Cardiovascular (CV) advisory committee, with a decision of Substantially Equivalent (SESE) to a predicate device. This implies it meets FDA standards for medical information systems (MWI) and adheres to regulatory requirements for data aggregation and connectivity in healthcare settings.