# K032142: Datacaptor

- Pathway: 510(k) (Special)
- Applicant: Capsule Technologie
- Decided: Aug 8, 2003 after 25 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: 3 generations back to K000635 (2000). 3 ancestors in all.
11 later devices descend from it; 5 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)
- K013019: Datacaptor, Capsule Technologie (2001)
- K020197: Modification to Datacaptor, Capsule Technologie (2002)

## Most influential descendants
- 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
- K170032: QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP (2017), 1 descendant of its own
- K241766: QMAPP®  (Hemo, Hemo Lite, PCM, GO, Hybrid) (2025), 0 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/K032142
Methodology: https://510kreport.com/methodology