510(k) · Cleared
Recalled · Class II · 2012Datacaptor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Capsule Technologie · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Aug 8, 2003 as substantially equivalent to K013019 (Capsule Technologie, 2001) and 1 other predicate after a 25-day review. Its family tree reaches back 3 generations to 2000. 11 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 8, 2003
- Review
- 25 days
- Class
- Class II
- Product code
- MWI
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to K000635 (2000). 11 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK000635 Modification to HP M2376A Device Link SystemAgilent Technologies, Inc. · 2000
- 2 generations backK013019 DatacaptorCapsule Technologie · 2001 · Recalled
- 1 generation backK020197 Modification to DatacaptorCapsule Technologie · 2002 · Recalled
- This deviceK032142 DatacaptorCapsule Technologie · 2003
- Descendant · cites it directly · 6 of its ownK040969 Poise DataenginePoise Technology Corporation · 2004
- Descendant · 2 generations on · 5 of its ownK101571 Xper Information Management and Flex Cardio Physiomonitoring SystemsWitt Biomedical Corp · 2010 · Recalled
- Descendant · 3 generations on · 3 of its ownK131497 Mckesson Cardiology HemoMckesson Israel, Ltd. · 2013 · Recalled
- Descendant · 4 generations on · 1 of its ownK170032 QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM…Fysicon BV · 2017
- Descendant · 4 generations on · 0 of its ownK241766 QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K040969Poise DataenginePoise Technology Corporation · 2004 · cites it directly6descendants
- K101571Xper Information Management and Flex Cardio Physiomonitoring SystemsWitt Biomedical Corp · 2010 · 2 generations on5descendants
- K131497Mckesson Cardiology HemoMckesson Israel, Ltd. · 2013 · 3 generations on3descendants
- K170032QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EPFysicon BV · 2017 · 4 generations on1descendant
- K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000635 | Modification to HP M2376A Device Link System | Agilent Technologies, Inc. | 2000 | — |
| −2 | K013019 | Datacaptor | Capsule Technologie | 2001 | 2 |
| −1 | K020197 | Modification to Datacaptor | Capsule Technologie | 2002 | 2 |
| 0 (this device) | K032142 | Datacaptor | Capsule Technologie | 2003 | — |
| +1 | K040969 | Poise Dataengine | Poise Technology Corporation | 2004 | — |
| +2 | K101571 | Xper Information Management and Flex Cardio Physiomonitoring Systems | Witt Biomedical Corp | 2010 | 8 |
| +3 | K131497 | Mckesson Cardiology Hemo | Mckesson Israel, Ltd. | 2013 | 10 |
| +4 | K170032 | QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO… | Fysicon BV | 2017 | — |
| +4 | K241766 | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) | Fysicon BV | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MWI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
What descends from it? (11)
See all 115 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 10, 2012 | Class II | Z-2377-2012 | Device Design | 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 design | 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K040969 (Poise Technology Corporation, 2004) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K013019.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032142 · printed Nov 3, 2026
Cite this page
510(k) Report. “K032142: Datacaptor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032142
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026