510(k) · Cleared
Recalled · Class II · 2025CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Apr 12, 2022 as substantially equivalent to K200494 (GE Healthcare, 2020) after a 194-day review. Its family tree reaches back 9 generations to 2000. 3 later devices descend from it. It has been recalled once.
- Decided
- Apr 12, 2022
- Review
- 194 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 9 generations to K000815 (2000). 24 ancestors in all, the oldest K900598 (1990). 3 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK000815 AS/3 Anesthesia Montior with S-ANE99(a)/L-ARK99(a)Datex-Ohmeda · 2000
- 5 generations between
- 3 generations backK132533 Carescape Monitor B450GE Healthcare Finland Oy · 2013 · Recalled
- 2 generations backK190008 Carescape OneGE Healthcare · 2019
- 1 generation backK200494 CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP…GE Healthcare · 2020 · Recalled
- This deviceK213234 CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and…Ge Medical Systems Information Technologies, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK221953 Masimo CARESCAPE SpO2 – Masimo with SpHbMasimo Corporation · 2022
- Descendant · cites it directly · 0 of its ownK260656 Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES…GE Healthcare Finland Oy · 2026
- Descendant · 2 generations on · 0 of its ownK232389 Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation · 2023
Show all 9 generations
- Root · 9 generations backK000815 AS/3 Anesthesia Montior with S-ANE99(a)/L-ARK99(a)Datex-Ohmeda · 2000
- 8 generations backK021279 Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A SoftwareDatex-Ohmeda · 2002
- 7 generations backK030812 Datex-Ohmeda S/5 Anesthesia Monitor with L-AN03 and L-ANE03A SoftwareDatex-Ohmeda · 2003
- 6 generations backK051400 Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A…GE Healthcare · 2006
- 5 generations backK092027 Carescape Monitor B850Ge Medical Systems Information Technologies · 2009 · Recalled
- 4 generations backK102239 Carescape Monitor B650GE Healthcare Finland Oy · 2010 · Recalled
- 3 generations backK132533 Carescape Monitor B450GE Healthcare Finland Oy · 2013 · Recalled
- 2 generations backK190008 Carescape OneGE Healthcare · 2019
- 1 generation backK200494 CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP…GE Healthcare · 2020 · Recalled
- This deviceK213234 CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and…Ge Medical Systems Information Technologies, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See all- K221953Masimo CARESCAPE SpO2 – Masimo with SpHbMasimo Corporation · 2022 · cites it directly1descendant
- K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP…GE Healthcare Finland Oy · 2026 · cites it directly0descendants
- K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K000815 | AS/3 Anesthesia Montior with S-ANE99(a)/L-ARK99(a) | Datex-Ohmeda | 2000 | — |
| −8 | K021279 | Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A Software | Datex-Ohmeda | 2002 | — |
| −7 | K030812 | Datex-Ohmeda S/5 Anesthesia Monitor with L-AN03 and L-ANE03A Software | Datex-Ohmeda | 2003 | — |
| −6 | K051400 | Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A Software, Using… | GE Healthcare | 2006 | — |
| −5 | K092027 | Carescape Monitor B850 | Ge Medical Systems Information Technologies | 2009 | 9 |
| −4 | K102239 | Carescape Monitor B650 | GE Healthcare Finland Oy | 2010 | 8 |
| −3 | K132533 | Carescape Monitor B450 | GE Healthcare Finland Oy | 2013 | 3 |
| −2 | K190008 | Carescape One | GE Healthcare | 2019 | — |
| −1 | K200494 | CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE… | GE Healthcare | 2020 | 1 |
| 0 (this device) | K213234 | CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101… | Ge Medical Systems Information Technologies, Inc. | 2022 | — |
| +1 | K221953 | Masimo CARESCAPE SpO2 – Masimo with SpHb | Masimo Corporation | 2022 | — |
| +1 | K260656 | Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM… | GE Healthcare Finland Oy | 2026 | — |
| +2 | K232389 | Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue | Masimo Corporation | 2023 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K200494 | CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRESSummary page 8…K213234 Page 2 of 14 Predicate Device(s) The primary predicate for this submission is K200494, (807.92(a)(3)): CARESCAPE ONE Additional reference devices:… | 2020 |
| † | K191149 | Carescape B650 | 2020 |
| † | K191323 | Carescape B850 | 2020 |
| † | K191249 | Carescape B450 | 2020 |
| † | K182868 | INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor | 2019 |
| † | K110028 | Masimo Radical Y Pulse CO-Oximeter | 2011 |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 26, 2025 | Class II | Z-0454-2026 | Component change control | Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 10 of the 24 ancestors have a recall of any class.
- Of its descendants, K221953 (Masimo Corporation, 2022) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K200494.
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. 2022, 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 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…
Read the full statement (354 words)
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 [SpO2], 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, FiCO2, 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.
CARESCAPE ONE is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.
Regional oxygen saturation (rSO2) is an adjunct parameter for noninvasive monitoring of cerebral/somatic regional oximetry of blood in the brain or other tissue beneath the sensor. It is intended to be used on patients greater than 40 kg (88 lbs) at risk for reduced-flow or no-flow ischemic states.
CARESCAPE ONE is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in the 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213234 · printed Nov 5, 2026
Cite this page
510(k) Report. “K213234: CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K213234
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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