510(k) · Cleared
ClearedIntegriti Patient Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alliance Instruments · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Mar 16, 1999 after a 386-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Mar 16, 1999
- Review
- 386 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK980688 Integriti Patient MonitorAlliance Instruments · 1999
- 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 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · 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 |
|---|---|---|---|---|---|
| 0 (this device) | K980688 | Integriti Patient Monitor | Alliance Instruments | 1999 | — |
| +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 |
|---|---|---|
| 2006 | 1 | 0 |
| 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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K101571 (Witt Biomedical Corp, 2010) has gone furthest, with 5 descendants of its own.
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 Integriti Patient Monitor is intended for use on all adult and pediatric patients that require monitoring and collection of vital signs data, with alarm capability when vital signs exceed preset values. The information that is intended to be collected is from the ECG, SpO2, noninvasive and invasive blood pressures and temperature. The Integriti Patient Monitor is intended for use in all departments and locations of the hospital where such monitoring…
Read the full statement (173 words)
The Integriti Patient Monitor is intended for use on all adult and pediatric patients that require monitoring and collection of vital signs data, with alarm capability when vital signs exceed preset values. The information that is intended to be collected is from the ECG, SpO2, noninvasive and invasive blood pressures and temperature. The Integriti Patient Monitor is intended for use in all departments and locations of the hospital where such monitoring may take place, except in the proximity of magnetic resonance imaging. The Integriti Patient Monitor is also intended for use for patient vital signs monitoring during patient transport in the hospital environment. The Integriti Patient Monitor is intended for use by licensed practitioners. When there is no standard electrical power source, the Integriti Patient Monitor is intended for use using a 12 to 28 volt external power source. The Integriti Patient Monitor is also intended for use with patient information systems, acting as a source of vital signs information and as a terminal for accessing and entering information into the information system.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980688: Integriti Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980688
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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