510(k) · Cleared
ClearedPoise Dataengine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Poise Technology Corporation · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Jun 8, 2004 as substantially equivalent to K032142 (Capsule Technologie, 2003) after a 55-day review. Its family tree reaches back 4 generations to 2000. 6 later devices descend from it.
- Decided
- Jun 8, 2004
- Review
- 55 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000635 (2000). 6 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK000635 Modification to HP M2376A Device Link SystemAgilent Technologies, Inc. · 2000
- 3 generations backK013019 DatacaptorCapsule Technologie · 2001 · Recalled
- 2 generations backK020197 Modification to DatacaptorCapsule Technologie · 2002 · Recalled
- 1 generation backK032142 DatacaptorCapsule Technologie · 2003 · Recalled
- This deviceK040969 Poise DataenginePoise Technology Corporation · 2004
- Descendant · cites it directly · 5 of its ownK101571 Xper Information Management and Flex Cardio Physiomonitoring SystemsWitt Biomedical Corp · 2010 · Recalled
- Descendant · 2 generations on · 3 of its ownK131497 Mckesson Cardiology HemoMckesson Israel, Ltd. · 2013 · Recalled
- Descendant · 3 generations on · 1 of its ownK170032 QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM…Fysicon BV · 2017
- Descendant · 3 generations on · 0 of its ownK241766 QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV · 2025
- Descendant · 3 generations on · 0 of its ownK230881 Change Healthcare Cardiology Hemodynamics™Change Healthcare Israel, Ltd. · 2023 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K101571Xper Information Management and Flex Cardio Physiomonitoring SystemsWitt Biomedical Corp · 2010 · cites it directly5descendants
- K131497Mckesson Cardiology HemoMckesson Israel, Ltd. · 2013 · 2 generations on3descendants
- K170032QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EPFysicon BV · 2017 · 3 generations on1descendant
- K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV · 2025 · 3 generations on0descendants
- K230881Change Healthcare Cardiology Hemodynamics™Change Healthcare Israel, Ltd. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000635 | Modification to HP M2376A Device Link System | Agilent Technologies, Inc. | 2000 | — |
| −3 | K013019 | Datacaptor | Capsule Technologie | 2001 | 2 |
| −2 | K020197 | Modification to Datacaptor | Capsule Technologie | 2002 | 2 |
| −1 | K032142 | Datacaptor | Capsule Technologie | 2003 | 2 |
| 0 (this device) | K040969 | Poise Dataengine | Poise Technology Corporation | 2004 | — |
| +1 | K101571 | Xper Information Management and Flex Cardio Physiomonitoring Systems | Witt Biomedical Corp | 2010 | 8 |
| +2 | K131497 | Mckesson Cardiology Hemo | Mckesson Israel, Ltd. | 2013 | 10 |
| +3 | K170032 | QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO… | Fysicon BV | 2017 | — |
| +3 | K241766 | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) | Fysicon BV | 2025 | — |
| +3 | K230881 | Change Healthcare Cardiology Hemodynamics™ | Change Healthcare Israel, Ltd. | 2023 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032142 | DatacaptorSummary page 1…on number: MWI, Class 11 * Regulation Number: 870.2300 2. Equivalent legal marketed device: * CAPSULE TECHNOLOGIE * Datacaptor, K032142 3. Indications for Use ( intended use) * DataEngine is indicated for use in data collection and clinical… | 2003 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101571 | Xper Information Management and Flex Cardio Physiomonitoring Systems | 2010 | 5 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K101571 (Witt Biomedical Corp, 2010) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K032142.
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?
DataEngine is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. DataEngine 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/K040969 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040969: Poise Dataengine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040969
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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