510(k) · Cleared
ClearedCarescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare Finland Oy · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Sep 1, 2026 as substantially equivalent to K213234 (Ge Medical Systems Information Technologies, Inc., 2022) after a 186-day review. Its family tree reaches back 10 generations to 2000.
- Decided
- Sep 1, 2026
- Review
- 186 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K000815 (2000). 25 ancestors in all, the oldest K900598 (1990). No later device cites it as a predicate yet.
- Root · 10 generations backK000815 AS/3 Anesthesia Montior with S-ANE99(a)/L-ARK99(a)Datex-Ohmeda · 2000
- 6 generations between
- 3 generations backK190008 Carescape OneGE Healthcare · 2019
- 2 generations backK200494 CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP…GE Healthcare · 2020 · Recalled
- 1 generation backK213234 CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and…Ge Medical Systems Information Technologies, Inc. · 2022 · Recalled
- This deviceK260656 Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES…GE Healthcare Finland Oy · 2026
Show all 10 generations
- Root · 10 generations backK000815 AS/3 Anesthesia Montior with S-ANE99(a)/L-ARK99(a)Datex-Ohmeda · 2000
- 9 generations backK021279 Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A SoftwareDatex-Ohmeda · 2002
- 8 generations backK030812 Datex-Ohmeda S/5 Anesthesia Monitor with L-AN03 and L-ANE03A SoftwareDatex-Ohmeda · 2003
- 7 generations backK051400 Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A…GE Healthcare · 2006
- 6 generations backK092027 Carescape Monitor B850Ge Medical Systems Information Technologies · 2009 · Recalled
- 5 generations backK102239 Carescape Monitor B650GE Healthcare Finland Oy · 2010 · Recalled
- 4 generations backK132533 Carescape Monitor B450GE Healthcare Finland Oy · 2013 · Recalled
- 3 generations backK190008 Carescape OneGE Healthcare · 2019
- 2 generations backK200494 CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP…GE Healthcare · 2020 · Recalled
- 1 generation backK213234 CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and…Ge Medical Systems Information Technologies, Inc. · 2022 · Recalled
- This deviceK260656 Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES…GE Healthcare Finland Oy · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K000815 | AS/3 Anesthesia Montior with S-ANE99(a)/L-ARK99(a) | Datex-Ohmeda | 2000 | — |
| −9 | K021279 | Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A Software | Datex-Ohmeda | 2002 | — |
| −8 | K030812 | Datex-Ohmeda S/5 Anesthesia Monitor with L-AN03 and L-ANE03A Software | Datex-Ohmeda | 2003 | — |
| −7 | K051400 | Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A Software, Using… | GE Healthcare | 2006 | — |
| −6 | K092027 | Carescape Monitor B850 | Ge Medical Systems Information Technologies | 2009 | 9 |
| −5 | K102239 | Carescape Monitor B650 | GE Healthcare Finland Oy | 2010 | 8 |
| −4 | K132533 | Carescape Monitor B450 | GE Healthcare Finland Oy | 2013 | 3 |
| −3 | K190008 | Carescape One | GE Healthcare | 2019 | — |
| −2 | K200494 | CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE… | GE Healthcare | 2020 | 1 |
| −1 | K213234 | CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101… | Ge Medical Systems Information Technologies, Inc. | 2022 | 1 |
| 0 (this device) | K260656 | Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM… | GE Healthcare Finland Oy | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 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 MHX? 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 MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 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 |
|---|---|---|---|
| * | K213234 | CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG…Summary page 9…inland Phone: +358 10 39411 Predicate Device(s) Primary predicate: (807.92(a)(3)): K213234 CARESCAPE ONE and CARESCAPE DOCK F0, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES an… | 2022 |
| † | K213363 | CARESCAPE B450, E-musb | 2022 |
| † | K234130 | Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application… | 2024 |
| † | K211561 | INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 11 of the 25 ancestors have a recall of any class.
- 1 other device also cites its predicate K213234.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, 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 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
Carescape ONE: Carescape ONE is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. Carescape ONE is indicated for the monitoring of hemodynamic and respiratory physiological parameters. When the Carescape ONE is operated as a standalone multi-parameter physiological patient monitor, it provides…
Read the full statement (765 words)
Carescape ONE:
Carescape ONE is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility.
Carescape ONE is indicated for the monitoring of hemodynamic and respiratory physiological parameters.
When the Carescape ONE is operated as a standalone multi-parameter physiological patient monitor, it provides the following physiological parameters:
* ECG (heart rate, ST segment, and arrhythmia detection)
* Pulse oximetry (pulse rate, functional oxygen saturation [SpO2])
* Non-invasive blood pressure (systolic, diastolic, and mean arterial pressures)
* Invasive pressure (pulse rate and systolic, diastolic, and mean pressures)
* Temperature
» Respiratory carbon dioxide (EtCO2, FICO2, and respiration rate)
* Impedance respiration
When the Carescape ONE is connected as an accessory to a compatible Host Monitor, it provides the following physiological parameters to the Host Monitor:
* ECG (heart rate, ST segment, and arrhythmia detection)
* Pulse oximetry (pulse rate, functional oxygen saturation [SpOZ2], and total hemoglobin concentration [SpHb])
* Non-invasive blood pressure (systolic, diastolic, and mean arterial pressures)
* Invasive pressure (pulse rate and systolic, diastolic, and mean pressures)
* Regional oxygen saturation (rSO2)
* Temperature
* Respiratory carbon dioxide (EtCO2, FiICO2, and respiration rate)
* Impedance respiration
When the Carescape ONE is connected as an accessory to a compatible host monitor, visual and audible alarms, user controls, and user interface are provided on the compatible host monitor and not on Carescape ONE.
When Carescape ONE is operated as a transportable monitor, it can interface with a compatible host monitor to provide data for remote viewing and data management software devices via a network.
Carescape ONE is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.
Carescape ONE is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
Contraindications for using Carescape ONE:
The Carescape ONE is not intended for use within a controlled MR environment.
Carescape Dock FO:
Carescape Dock FO is intended for providing a DC power source to a docked Carescape ONE, which also charges the Carescape ONE battery. Carescape Dock FO is intended to provide a docked Carescape ONE with communication to the host monitor.
The Carescape Dock FO is indicated for use in multiple areas within a professional healthcare facility.
The Carescape Dock FO is indicated for use under the direct supervision of a licensed healthcare practitioner, or by person trained in proper use of the equipment in a professional healthcare facility.
The Carescape Dock FO is indicated for use on adult, pediatric, and neonatal patients and on one patient at a time.
Contraindications for using Carescape Dock FO:
The Carescape Dock FO is not intended for use within a controlled MR environment.
TruSignal ECG MM
The TruSignal ECG MM is intended for monitoring of electrocardiogram and impedance respiration. TruSignal ECG MM is indicated for all hospital patients. The device is indicated for use by licensed healthcare practitioner.
Contraindications for using the TruSignal ECG MM Device
The TruSignal ECG MM is not intended for use within a controlled MR environment.
TruSignal PRES MM
The TruSignal PRES MM is intended for monitoring of invasive pressure and pulse rate. TruSignal PRES MM is indicated for all hospital patients. The device is indicated for use by licensed healthcare practitioner.
Contraindications for using the TruSignal PRES MM Device
The TruSignal PRES MM is not intended for use within a controlled MR environment.
TruSignal TEMP MM
The TrusSignal TEMP MM 1s intended for monitoring of temperature. [ruSignal TEMP MM is indicated for all hospital patients. The device is indicated for use by licensed healthcare practitioner.
Contraindications for using the TruSignal TEMP MM Device
The TruSignal TEMP MM is not intended for use within a controlled MR environment.
TruSignal SpO2 MM 1.8M
The TruSignal SpO2 MM 1.8M is intended for monitoring arterial oxygen saturation and pulse rate. TruSignal SpO2 MM 1.8M is indicated for all hospital patients. The device is indicated for use by licensed healthcare practitioner.
Contraindications for using the TruSignal SpO2 MM 1.8M Device
The TruSignal SpO2 MM 1.8M is not intended for use within a controlled MR environment.
TruSignal SpO2 MM 3.0M
The TruSignal SpO2 MM 3.0M is intended for monitoring arterial oxygen saturation and pulse rate. TruSignal SpO2 MM 3.0M is indicated for all hospital patients. The device is indicated for use by licensed healthcare practitioner.
Contraindications for using the TruSignal SpO2 MM 3.0M Device
The TruSignal SpO2 MM 3.0M is not intended for use within a controlled MR environment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K260656 · printed Nov 3, 2026
Cite this page
510(k) Report. “K260656: Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K260656
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026