510(k) · Cleared
Recalled · Class II · 2015Carescape Monitor B850
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Aug 28, 2009 as substantially equivalent to K071073 (Ge Medical Systems Information Technologies, 2007) and 1 other predicate after a 53-day review. Its family tree reaches back 4 generations to 2000. 1 of the 50 devices in its family, counting itself, has a Class I recall. 38 later devices descend from it. It has been recalled 9 times.
- Decided
- Aug 28, 2009
- Review
- 53 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 9
- Predicates
- 2
Its longest line of descent runs back 4 generations to K000815 (2000). 11 ancestors in all, the oldest K900598 (1990). 38 later devices descend from it, 2 citing it directly. 1 of the 50 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK000815 AS/3 Anesthesia Montior with S-ANE99(a)/L-ARK99(a)Datex-Ohmeda · 2000
- 3 generations backK021279 Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A SoftwareDatex-Ohmeda · 2002
- 2 generations backK030812 Datex-Ohmeda S/5 Anesthesia Monitor with L-AN03 and L-ANE03A SoftwareDatex-Ohmeda · 2003
- 1 generation backK051400 Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A…GE Healthcare · 2006
- This deviceK092027 Carescape Monitor B850Ge Medical Systems Information Technologies · 2009
- Descendant · cites it directly · 32 of its ownK102239 Carescape Monitor B650GE Healthcare Finland Oy · 2010 · Recalled
- Descendant · 2 generations on · 14 of its ownK132533 Carescape Monitor B450GE Healthcare Finland Oy · 2013 · Recalled
- Descendant · 2 generations on · 13 of its ownK131223 Carescape Monitor B650GE Healthcare Finland Oy · 2013 · Recalled
- Descendant · 3 generations on · 11 of its ownK190008 Carescape OneGE Healthcare · 2019
- Descendant · 4 generations on · 10 of its ownK200494 CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP…GE Healthcare · 2020 · Recalled
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K133576 Monitor B403 generations on · 2014
Most influential descendants
Showing 5 of 38 · See all- K102239Carescape Monitor B650GE Healthcare Finland Oy · 2010 · cites it directly32descendants
- K132533Carescape Monitor B450GE Healthcare Finland Oy · 2013 · 2 generations on14descendants
- K131223Carescape Monitor B650GE Healthcare Finland Oy · 2013 · 2 generations on13descendants
- K190008Carescape OneGE Healthcare · 2019 · 3 generations on11descendants
- K200494CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRESGE Healthcare · 2020 · 4 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000815 | AS/3 Anesthesia Montior with S-ANE99(a)/L-ARK99(a) | Datex-Ohmeda | 2000 | — |
| −3 | K021279 | Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A Software | Datex-Ohmeda | 2002 | — |
| −2 | K030812 | Datex-Ohmeda S/5 Anesthesia Monitor with L-AN03 and L-ANE03A Software | Datex-Ohmeda | 2003 | — |
| −1 | K051400 | Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A Software, Using… | GE Healthcare | 2006 | — |
| 0 (this device) | K092027 | Carescape Monitor B850 | Ge Medical Systems Information Technologies | 2009 | — |
| +1 | K102239 | Carescape Monitor B650 | GE Healthcare Finland Oy | 2010 | 8 |
| +2 | K132533 | Carescape Monitor B450 | GE Healthcare Finland Oy | 2013 | 3 |
| +2 | K131223 | Carescape Monitor B650 | GE Healthcare Finland Oy | 2013 | 4 |
| +3 | K190008 | Carescape One | GE Healthcare | 2019 | — |
| +4 | K200494 | CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE… | GE Healthcare | 2020 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 5 | 0 |
| 2014 | 1 | 1 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 5 | 0 |
| 2021 | 1 | 0 |
| 2022 | 6 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 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.
1 device in this family has a Class I recall. 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071073 | Solar 8000 and Transport Pro with Patient Data ModuleSummary page 1…870.1025 Arrhythmia detector and alarm (including ST- segment measurement and alarm) Product Code: MHX Predicate Device(s):K071073: Solar 8000 and Transport Pro with Patient Data Module K051400: Datex Ohmed… | 2007 |
| * | K051400 | Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A Software, Using F-CU8 or…Summary page 1…Product Code: MHX Predicate Device(s):K071073: Solar 8000 and Transport Pro with Patient Data Module K051400: Datex Ohmeda S/5 Anesthesia Monitor with L-ANE05 and L-ANE05A software Device Description: The… | 2006 |
What descends from it? (38)
See all 382 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 4, 2015 | Class II | Z-1606-2015 | Software design | The heart rate could be calculated from pacer pulses without indication that pacemaker detection is OFF in some combinations of Bx50 monitors, a PDM, and CIC/CSCS. Then the monitor does not show the Pacer Off message and there may not be… |
| Jun 13, 2014 | Class II | Z-2085-2014 | Software design | Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 the PDM may not start communicating to the monitor… |
| Feb 28, 2014 | Class II | Z-1175-2014 | Software design | GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. These issues include both NIBP (Non-Invasive Blood Pressure) and Bed to Bed Issues. |
| Dec 27, 2013 | Class II | Z-0854-2014 | Software design | GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. These included 25 issues related to NIBP (Non-InvasiVentilation Alarms:ve Blood Pressure) , ECG… |
| Dec 20, 2013 | Class II | Z-0927-2014 | Component change control | There is a potential for communication loss associated with the F5-01 Frame when connected to CARESCAPE Patient Data Module (PDM) in the CARESCAPE Monitor B850. The PDM patient parameter acquisition module can sometimes spontaneously lose… |
| Jul 20, 2012 | Class II | Z-1567-2013 | Software design | GE Healthcare become aware of 4 potential issues associated with the CARESCAPE Monitor B850. These issues include CARESCAPE Monitor B850 uDOM failure, CARESCAPE Monitor B850 unstable USB communication, CARESCAPE Monitor B850 remote… |
| Jul 20, 2011 | Class II | Z-2201-2013 | Software design | GE Healthcare has recently become aware of an issue associated with the CARESCAPE Monitor B850 when used with the iCentral network. The iCentral must have the alarm management software license (L-NETM-00) and the alarm limit change option… |
| Mar 8, 2011 | Not classified | Z-1929-2011 | Software design | GE Healthcare has become aware of potential safety issues associated with the CARESCAPE" Monitor B850 when Patient Data Module (PDM), Tram Acquisition Module (Tram), Patient Side Module (E-PSM or E-PSMP), E- MASIMO or E-(P)RE(S)TN modules… |
| Jul 16, 2010 | Not classified | Z-2275-2010 | Software design | GE Healthcare has become aware of four potential safety issues associated with the CARESCAPE" Monitor B850: 1. Loss of user input when using certain displays or the USB remote control. 2. Potential for a delay in treatment or missed alarm… |
The 5 latest of 9 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 4 of the 11 ancestors have a recall of any class.
- Of its descendants, K102239 (GE Healthcare Finland Oy, 2010) has gone furthest, with 32 descendants of its own.
- 4 other devices also cite its predicate K071073.
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. 2009, 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?
The CARESCAPE™ Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive…
Read the full statement (246 words)
The CARESCAPE™ Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility.
The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time
The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation)), Airway Gases (Fi/Et C02, 02, N20 and Anesthetic Agent), Spirometry, Gas Exchange (02 Consumption (VO2), C02 production (VCO2), energy expenditure (BE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status.
The CARESCAPE Monitor B850 provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices. The CARESCAPE Monitor B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for bed to bed viewing and to data management software devices via a network.
The CARESCAPE Monitor B850 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. In addition to the healthcare practitioner, the CARESCAPE Monitor B850 is designed to provide configuration and troubleshooting capabilities to qualified service personnel.
The CARESCAPE Monitor B850 is not intended for use during MRI.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092027 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092027: Carescape Monitor B850.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092027
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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