# K013019: Datacaptor

- Pathway: 510(k) (Traditional)
- Applicant: Capsule Technologie
- Decided: Dec 18, 2001 after 102 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000635 (2000). 1 ancestor in all.
13 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000635: Modification to HP M2376A Device Link System, Agilent Technologies, Inc. (2000) Summary page 1.

## Most influential descendants
- K020197: Modification to Datacaptor (2002), 12 descendants of its own
- K032142: Datacaptor (2003), 11 descendants of its own
- K040969: Poise Dataengine (2004), 6 descendants of its own
- K101571: Xper Information Management and Flex Cardio Physiomonitoring Systems (2010), 5 descendants of its own
- K131497: Mckesson Cardiology Hemo (2013), 3 descendants of its own

## 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
- Aug 25, 2010 · Not classified · Z-2403-2011: 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 c

## 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™ is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.

Source page: https://510kreport.com/device/K013019
Methodology: https://510kreport.com/methodology