510(k) · Cleared
Recalled · Class II · 2024Carescape 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 Jan 21, 2020 as substantially equivalent to K131223 (GE Healthcare Finland Oy, 2013) after a 266-day review. Its family tree reaches back 7 generations to 2000. 7 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 21, 2020
- Review
- 266 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 7 generations to K000815 (2000). 22 ancestors in all, the oldest K900598 (1990). 7 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK000815 AS/3 Anesthesia Montior with S-ANE99(a)/L-ARK99(a)Datex-Ohmeda · 2000
- 6 generations backK021279 Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A SoftwareDatex-Ohmeda · 2002
- 5 generations backK030812 Datex-Ohmeda S/5 Anesthesia Monitor with L-AN03 and L-ANE03A SoftwareDatex-Ohmeda · 2003
- 4 generations backK051400 Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A…GE Healthcare · 2006
- 3 generations backK092027 Carescape Monitor B850Ge Medical Systems Information Technologies · 2009 · Recalled
- 2 generations backK102239 Carescape Monitor B650GE Healthcare Finland Oy · 2010 · Recalled
- 1 generation backK131223 Carescape Monitor B650GE Healthcare Finland Oy · 2013 · Recalled
- This deviceK191149 Carescape B650GE Healthcare Finland Oy · 2020
- Descendant · cites it directly · 6 of its ownK213181 CARESCAPE B650, E-musbGE Healthcare Finland Oy · 2022 · Recalled
- Descendant · 2 generations on · 5 of its ownK230579 Smart Wedge algorithmEdwards Lifesciences, LLC · 2023
- Descendant · 3 generations on · 4 of its ownK242451 HemoSphere Alta Advanced Monitoring Platform…Edwards Lifesciences · 2024
- Descendant · 4 generations on · 2 of its ownK243781 HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module…Edwards Lifesciences · 2025 · Recalled
- Descendant · 5 generations on · 0 of its ownK253186 HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K213181CARESCAPE B650, E-musbGE Healthcare Finland Oy · 2022 · cites it directly6descendants
- K230579Smart Wedge algorithmEdwards Lifesciences, LLC · 2023 · 2 generations on5descendants
- K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences · 2024 · 3 generations on4descendants
- K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences · 2025 · 4 generations on2descendants
- K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K000815 | AS/3 Anesthesia Montior with S-ANE99(a)/L-ARK99(a) | Datex-Ohmeda | 2000 | — |
| −6 | K021279 | Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A Software | Datex-Ohmeda | 2002 | — |
| −5 | K030812 | Datex-Ohmeda S/5 Anesthesia Monitor with L-AN03 and L-ANE03A Software | Datex-Ohmeda | 2003 | — |
| −4 | K051400 | Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A Software, Using… | GE Healthcare | 2006 | — |
| −3 | K092027 | Carescape Monitor B850 | Ge Medical Systems Information Technologies | 2009 | 9 |
| −2 | K102239 | Carescape Monitor B650 | GE Healthcare Finland Oy | 2010 | 8 |
| −1 | K131223 | Carescape Monitor B650 | GE Healthcare Finland Oy | 2013 | 4 |
| 0 (this device) | K191149 | Carescape B650 | GE Healthcare Finland Oy | 2020 | — |
| +1 | K213181 | CARESCAPE B650, E-musb | GE Healthcare Finland Oy | 2022 | 2 |
| +2 | K230579 | Smart Wedge algorithm | Edwards Lifesciences, LLC | 2023 | — |
| +3 | K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1)… | Edwards Lifesciences | 2024 | — |
| +4 | K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10)… | Edwards Lifesciences | 2025 | 1 |
| +5 | K253186 | HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences, LLC | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K131223 | Carescape Monitor B650Summary page 7…SJ, DSK, DXG, DXN, FLL, GWJ, GWQ, KOI, KRB, MLD, NHO, NHP, NHQ, OLT, OLW, OMC, ORT Predicate Device(s) K131223 CARESCAPE Monitor B650 (807.92(a)(3): Device Description CARESCAPE B650 V3 is a new version of a por… | 2013 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213181 | CARESCAPE B650, E-musb | 2022 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 5, 2024 | Class II | Z-2172-2024 | Software design | GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU… |
| Apr 5, 2024 | Class II | Z-2171-2024 | Software design | GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 9 of the 22 ancestors have a recall of any class.
- Of its descendants, K213181 (GE Healthcare Finland Oy, 2022) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K131223.
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. 2020, 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 B650 is a multi-parameter patient monitor intended for use in multiple areas and intra hospital transport within a professional healthcare facility. The CARESCAPE B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B650 is indicated for monitoring of: ● hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure…
Read the full statement (279 words)
The CARESCAPE B650 is a multi-parameter patient monitor intended for use in multiple areas and intra hospital transport within a professional healthcare facility.
The CARESCAPE B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.
The CARESCAPE B650 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 (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation),
● respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange),
and
● neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).
The CARESCAPE 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 B650 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, irregular, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B650 also shows alarms from other ECG sources.
The CARESCAPE B650 also provides other alarms, trends, snapshots and events, and calculations, and can be connected to displays, printers and recording devices.
The CARESCAPE 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.
Contraindications for using the monitor
The CARESCAPE B650 is not intended for use in a controlled MR environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191149 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191149: Carescape B650.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191149
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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