# K113835: Datacaptor System

- Pathway: 510(k) (Traditional)
- Applicant: Capsule Tech, Inc.
- Decided: Jun 27, 2012 after 183 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K000635 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013019: Datacaptor, Capsule Technologie (2001) Summary page 1.
- K020197: Modification to Datacaptor, Capsule Technologie (2002) Summary page 1.
- K032142: Datacaptor, Capsule Technologie (2003) Summary page 1.

## Recalls of this device
- Aug 10, 2012 · Class II · 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

## Indications for use
The DataCaptor System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. DataCaptor m is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices (independent bedside devices / information systems) to which it is connected.

Source page: https://510kreport.com/device/K113835
Methodology: https://510kreport.com/methodology