510(k) · Cleared
Recalled · Class II · 2018Carescape Monitor B650
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 Oct 18, 2010 as substantially equivalent to K092027 (Ge Medical Systems Information Technologies, 2009) and 3 other predicates after a 70-day review. Its family tree reaches back 5 generations to 2000. 1 of the 53 devices in its family, counting itself, has a Class I recall. 32 later devices descend from it. It has been recalled 8 times.
- Decided
- Oct 18, 2010
- Review
- 70 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 8
- Predicates
- 4
Its longest line of descent runs back 5 generations to K000815 (2000). 20 ancestors in all, the oldest K900598 (1990). 32 later devices descend from it, 5 citing it directly. 1 of the 53 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK000815 AS/3 Anesthesia Montior with S-ANE99(a)/L-ARK99(a)Datex-Ohmeda · 2000
- 4 generations backK021279 Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A SoftwareDatex-Ohmeda · 2002
- 3 generations backK030812 Datex-Ohmeda S/5 Anesthesia Monitor with L-AN03 and L-ANE03A SoftwareDatex-Ohmeda · 2003
- 2 generations backK051400 Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A…GE Healthcare · 2006
- 1 generation backK092027 Carescape Monitor B850Ge Medical Systems Information Technologies · 2009 · Recalled
- This deviceK102239 Carescape Monitor B650GE Healthcare Finland Oy · 2010
- Descendant · cites it directly · 14 of its ownK132533 Carescape Monitor B450GE Healthcare Finland Oy · 2013 · Recalled
- Descendant · cites it directly · 13 of its ownK131223 Carescape Monitor B650GE Healthcare Finland Oy · 2013 · Recalled
- Descendant · 2 generations on · 11 of its ownK190008 Carescape OneGE Healthcare · 2019
- Descendant · 3 generations on · 10 of its ownK200494 CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP…GE Healthcare · 2020 · Recalled
- Descendant · cites it directly · 10 of its ownK120598 Procare Monitor B40Ge Medical Systems China Co., Ltd. · 2012 · Recalled
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K133576 Monitor B402 generations on · 2014
Most influential descendants
Showing 5 of 32 · See all- K132533Carescape Monitor B450GE Healthcare Finland Oy · 2013 · cites it directly14descendants
- K131223Carescape Monitor B650GE Healthcare Finland Oy · 2013 · cites it directly13descendants
- K190008Carescape OneGE Healthcare · 2019 · 2 generations on11descendants
- K200494CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRESGE Healthcare · 2020 · 3 generations on10descendants
- K120598Procare Monitor B40Ge Medical Systems China Co., Ltd. · 2012 · cites it directly10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000815 | AS/3 Anesthesia Montior with S-ANE99(a)/L-ARK99(a) | Datex-Ohmeda | 2000 | — |
| −4 | K021279 | Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A Software | Datex-Ohmeda | 2002 | — |
| −3 | K030812 | Datex-Ohmeda S/5 Anesthesia Monitor with L-AN03 and L-ANE03A Software | Datex-Ohmeda | 2003 | — |
| −2 | K051400 | Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A Software, Using… | GE Healthcare | 2006 | — |
| −1 | K092027 | Carescape Monitor B850 | Ge Medical Systems Information Technologies | 2009 | 9 |
| 0 (this device) | K102239 | Carescape Monitor B650 | GE Healthcare Finland Oy | 2010 | — |
| +1 | K132533 | Carescape Monitor B450 | GE Healthcare Finland Oy | 2013 | 3 |
| +1 | K131223 | Carescape Monitor B650 | GE Healthcare Finland Oy | 2013 | 4 |
| +2 | K190008 | Carescape One | GE Healthcare | 2019 | — |
| +3 | K200494 | CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE… | GE Healthcare | 2020 | 1 |
| +1 | K120598 | Procare Monitor B40 | Ge Medical Systems China Co., Ltd. | 2012 | 2 |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 1 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K092027 | Carescape Monitor B850Summary page 2…alarm) MHX Product Code: 20 Predicate Device(s): K092027 CARESCAPE~ Monitor B850 K061185 DATEX-OH-MEDA 5/5 COMPACT ANESTHESIA MONITOR WITH L… | 2009 |
| * | K061185 | Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE05A and L-CANE05A SoftwareSummary page 2…Product Code: 20 Predicate Device(s): K092027 CARESCAPE~ Monitor B850 K061185 DATEX-OH-MEDA 5/5 COMPACT ANESTHESIA MONITOR WITH L-CANEO5(A) SOFTWARE K03 1320 EK-… | 2006 |
| * | K031320 | EK-Pro Arrhythmia Detection AlgorithmSummary page 2…RESCAPE~ Monitor B850 K061185 DATEX-OH-MEDA 5/5 COMPACT ANESTHESIA MONITOR WITH L-CANEO5(A) SOFTWARE K03 1320 EK-PRO ARRH-YTH-MIA DETECTION ALGORITHM (EK-Pro VII) K092680 DATEX-OHMEDA S/5 ANEST… | 2003 |
| * | K092680 | Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO7 and L-ANEO7A Software Using F-CU8 or…Summary page 2…WITH L-CANEO5(A) SOFTWARE K03 1320 EK-PRO ARRH-YTH-MIA DETECTION ALGORITHM (EK-Pro VII) K092680 DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L- ANEO7 AND L-ANE07A SOFTWARE, USING E-CU8 OR F-CUS(P)… | 2009 |
What descends from it? (32)
See all 325 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 25, 2018 | Class II | Z-2340-2018 | Software design | When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the… |
| 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… |
| Jul 7, 2014 | Class II | Z-2114-2014 | Software design | Possible sound loss associated with the CARESCAPE Monitor B650. When an external display is connected to the CARESCAPE Monitor B650 using a USB extender cable with an active USB hub, the system may experience a sound loss including alarm… |
| 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… |
| Jul 12, 2012 | Class II | Z-2256-2013 | Software design | GE Healthcare has recently become aware of a number of potential issues associated with the CARESCAPE Monitor B650. No injuries or illnesses have been reported. |
| Sep 30, 2011 | Class II | Z-0823-2013 | Software design | GE Healthcare has become aware of potential issues associated with the CARESCAPE Monitor B650. There have been no reported illnesses or injuries that have occurred with the use of the device. |
| Mar 23, 2011 | Not classified | Z-1930-2011 | Software design | GE Healthcare has become aware of a potential safety issue associated with the CARESCAPE Monitor B650 & B850 Cardiac Output measurement using Patient Data Module (PDM), and activation of ECG Leads Off alarm in specific cases. 1. When the… |
The 5 latest of 8 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 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 7 of the 20 ancestors have a recall of any class.
- Of its descendants, K132533 (GE Healthcare Finland Oy, 2013) has gone furthest, with 14 descendants of its own.
- 1 other device also cites its predicate K092027.
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. 2010, 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 B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynarniic (including EGG, ST segment, arrhythmia detection, ECU…
Read the full statement (189 words)
The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.
The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynarniic (including EGG, ST segment, arrhythmia detection, ECU diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (C02, 02, N20 and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (HI1S) and neuromuscular transmission) status.
The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.
The CARiESCAPE Monitor B650 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.
The CARESCAPE Monitor B650 is not intended for use during MRI.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102239 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102239: Carescape Monitor B650.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102239
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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