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 Aug 28, 2013 as substantially equivalent to K102239 (GE Healthcare Finland Oy, 2010) after a 120-day review. Its family tree reaches back 6 generations to 2000. 13 later devices descend from it. It has been recalled 4 times.
- Decided
- Aug 28, 2013
- Review
- 120 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 6 generations to K000815 (2000). 21 ancestors in all, the oldest K900598 (1990). 13 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK000815 AS/3 Anesthesia Montior with S-ANE99(a)/L-ARK99(a)Datex-Ohmeda · 2000
- 5 generations backK021279 Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A SoftwareDatex-Ohmeda · 2002
- 4 generations backK030812 Datex-Ohmeda S/5 Anesthesia Monitor with L-AN03 and L-ANE03A SoftwareDatex-Ohmeda · 2003
- 3 generations backK051400 Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A…GE Healthcare · 2006
- 2 generations backK092027 Carescape Monitor B850Ge Medical Systems Information Technologies · 2009 · Recalled
- 1 generation backK102239 Carescape Monitor B650GE Healthcare Finland Oy · 2010 · Recalled
- This deviceK131223 Carescape Monitor B650GE Healthcare Finland Oy · 2013
- Descendant · cites it directly · 7 of its ownK191149 Carescape B650GE Healthcare Finland Oy · 2020 · Recalled
- Descendant · 2 generations on · 6 of its ownK213181 CARESCAPE B650, E-musbGE Healthcare Finland Oy · 2022 · Recalled
- Descendant · 3 generations on · 5 of its ownK230579 Smart Wedge algorithmEdwards Lifesciences, LLC · 2023
- Descendant · 4 generations on · 4 of its ownK242451 HemoSphere Alta Advanced Monitoring Platform…Edwards Lifesciences · 2024
- Descendant · cites it directly · 4 of its ownK191249 Carescape B450GE Healthcare Finland Oy · 2020
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K191149Carescape B650GE Healthcare Finland Oy · 2020 · cites it directly7descendants
- K213181CARESCAPE B650, E-musbGE Healthcare Finland Oy · 2022 · 2 generations on6descendants
- K230579Smart Wedge algorithmEdwards Lifesciences, LLC · 2023 · 3 generations on5descendants
- K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences · 2024 · 4 generations on4descendants
- K191249Carescape B450GE Healthcare Finland Oy · 2020 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000815 | AS/3 Anesthesia Montior with S-ANE99(a)/L-ARK99(a) | Datex-Ohmeda | 2000 | — |
| −5 | K021279 | Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A Software | Datex-Ohmeda | 2002 | — |
| −4 | K030812 | Datex-Ohmeda S/5 Anesthesia Monitor with L-AN03 and L-ANE03A Software | Datex-Ohmeda | 2003 | — |
| −3 | K051400 | Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A Software, Using… | GE Healthcare | 2006 | — |
| −2 | K092027 | Carescape Monitor B850 | Ge Medical Systems Information Technologies | 2009 | 9 |
| −1 | K102239 | Carescape Monitor B650 | GE Healthcare Finland Oy | 2010 | 8 |
| 0 (this device) | K131223 | Carescape Monitor B650 | GE Healthcare Finland Oy | 2013 | — |
| +1 | K191149 | Carescape B650 | GE Healthcare Finland Oy | 2020 | 2 |
| +2 | K213181 | CARESCAPE B650, E-musb | GE Healthcare Finland Oy | 2022 | 2 |
| +3 | K230579 | Smart Wedge algorithm | Edwards Lifesciences, LLC | 2023 | — |
| +4 | K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1)… | Edwards Lifesciences | 2024 | — |
| +1 | K191249 | Carescape B450 | GE Healthcare Finland Oy | 2020 | — |
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 |
|---|---|---|
| 2020 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 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 |
|---|---|---|---|
| * | K102239 | Carescape Monitor B650Summary page 1…DSI, DSJ, DSK, DXG, DXN, ILL, GWJ, GWQ, KOI, KRB, MLD, NHO, NHP, NHQ, OLT, OLW, OMVC, ORT Predicate Device(s) K102239 CARESCAPE Monitor B650 (807.92(a)(3):: 510(k) Summary K131223 CARESCAPE Monitor B650 Page 1 of 5… | 2010 |
What descends from it? (13)
See all 132 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 |
|---|---|---|---|---|
| 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… |
| 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 8 of the 21 ancestors have a recall of any class.
- Of its descendants, K191149 (GE Healthcare Finland Oy, 2020) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K102239.
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. 2013, 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 8650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor 8650 is indicated for monitoring of: "hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement…
Read the full statement (216 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 8650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.
The CARESCAPE Monitor 8650 is indicated for monitoring of:
"hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry. cardiac output (therrnodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation),
" Respiratory (impedance respiration, airway gases (C02, 02, N20 and anesthetic agents), spirometry, gas exchange) and
* neurophysiological status (including electroencephalography, Entropy, Bispectral Index (815), and neuromuscular transmission),
The CARESCAPE Monitor 8650 also provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices.
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 CARESCAPE 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 MR.I.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131223 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131223: 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/K131223
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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