510(k) · Cleared
Recalled · Class II · 2024CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)
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 Apr 6, 2023 as substantially equivalent to K213336 (GE Healthcare Finland Oy, 2022) after a 134-day review. Its family tree reaches back 8 generations to 2000. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Apr 6, 2023
- Review
- 134 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 8 generations to K000815 (2000). 15 ancestors in all, the oldest K900598 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK000815 AS/3 Anesthesia Montior with S-ANE99(a)/L-ARK99(a)Datex-Ohmeda · 2000
- 7 generations backK021279 Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A SoftwareDatex-Ohmeda · 2002
- 6 generations backK030812 Datex-Ohmeda S/5 Anesthesia Monitor with L-AN03 and L-ANE03A SoftwareDatex-Ohmeda · 2003
- 5 generations backK051400 Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A…GE Healthcare · 2006
- 4 generations backK092027 Carescape Monitor B850Ge Medical Systems Information Technologies · 2009 · Recalled
- 3 generations backK131414 Carescape Monitor B850GE Healthcare Finland Oy · 2013 · Recalled
- 2 generations backK191323 Carescape B850GE Healthcare Finland Oy · 2020 · Recalled
- 1 generation backK213336 Carescape B850, E-musbGE Healthcare Finland Oy · 2022 · Recalled
- This deviceK223531 CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE…GE Healthcare Finland Oy · 2023
- Descendant · cites it directly · 0 of its ownK260343 Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland Oy · 2026
Most influential descendants
Showing 1 of 1 · See all- K260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland Oy · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K000815 | AS/3 Anesthesia Montior with S-ANE99(a)/L-ARK99(a) | Datex-Ohmeda | 2000 | — |
| −7 | K021279 | Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A Software | Datex-Ohmeda | 2002 | — |
| −6 | K030812 | Datex-Ohmeda S/5 Anesthesia Monitor with L-AN03 and L-ANE03A Software | Datex-Ohmeda | 2003 | — |
| −5 | K051400 | Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A Software, Using… | GE Healthcare | 2006 | — |
| −4 | K092027 | Carescape Monitor B850 | Ge Medical Systems Information Technologies | 2009 | 9 |
| −3 | K131414 | Carescape Monitor B850 | GE Healthcare Finland Oy | 2013 | 3 |
| −2 | K191323 | Carescape B850 | GE Healthcare Finland Oy | 2020 | 1 |
| −1 | K213336 | Carescape B850, E-musb | GE Healthcare Finland Oy | 2022 | 1 |
| 0 (this device) | K223531 | CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19… | GE Healthcare Finland Oy | 2023 | — |
| +1 | K260343 | Carescape Canvas 1000; Carescape Canvas Smart Display | GE Healthcare Finland Oy | 2026 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K213336 | Carescape B850, E-musbSummary page 8…CBS, CCL, GWJ, GWQ, KOI, NHO, NHP, NHQ, OLT, OLW, OMC, ORT Predicate Device(s) The primary predicate for this submission is K213336 CARESCAPE (807.92(a)(3)): B850 V3.2 Reference devices:… | 2022 |
| † | K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P | 2022 |
| † | K211171 | CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260343 | Carescape Canvas 1000; Carescape Canvas Smart Display | 2026 | 0 |
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-2168-2024 | 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-2169-2024 | 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… |
| Sep 8, 2023 | Class II | Z-2656-2023 | Software design | There is a potential interruption of data communication between E-modules inserted in the F2-01 Frame and CARESCAPE ONE and CARESCAPE Canvas 1000 patient monitors if the F2-01 Frame has not been powered down within the last 120 days. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 8 of the 15 ancestors have a recall of any class.
- Of its descendants, K260343 (GE Healthcare Finland Oy, 2026) has gone furthest, with 0 descendants of its own.
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. 2023, 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?
Indications for Use for CARESCAPE Canvas 1000: CARESCAPE Canvas 1000 is a multi-parameter patient monitor intended for use in multiple areas within a professional healthcare facility. CARESCAPE Canvas 1000 is intended for use on adult, pediatric, and neonatal patients one patient at a time. CARESCAPE Canvas 1000 is indicated for monitoring of: • hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement…
Read the full statement (736 words)
Indications for Use for CARESCAPE Canvas 1000:
CARESCAPE Canvas 1000 is a multi-parameter patient monitor intended for use in multiple areas within a professional healthcare facility.
CARESCAPE Canvas 1000 is intended for use on adult, pediatric, and neonatal patients one patient at a time.
CARESCAPE Canvas 1000 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, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation),
• respiratory (impedance respiration, airway gases (CO2, 02, N2O, and anesthetic agents), spirometry, gas exchange), and
• neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).
CARESCAPE Canvas 1000 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, Ron T, supra ventricular tachycardia, tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ ventricular tachycardia, ventricular tachycardia, and VT>2. CARESCAPE Canvas 1000 also shows alarms from other ECG sources.
CARESCAPE Canvas 1000 also provides other alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices.
CARESCAPE Canvas 1000 can interface to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.
CARESCAPE Canvas 1000 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.
CARESCAPE Canvas 1000 is not intended for use in an MRI environment.
Indications for Use for CARESCAPE Canvas Smart Display:
CARESCAPE Canvas Smart Display is a multi-parameter patient monitor intended for use in multiple areas within a professional healthcare facility.
CARESCAPE Canvas Smart Display is intended for use on adult, pediatric, and neonatal patients one patient at a time.
CARESCAPE Canvas Smart Display 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, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution), and temperature, and
• respiratory (impedance respiration, airway gases (CO2)
CARESCAPE Canvas Smart Display 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. CARESCAPE Canvas Smart Display also shows alarms from other ECG sources.
CARESCAPE Canvas Smart Display also provides other alarms, trends, snapshots and events.
CARESCAPE Canvas Smart Display can use CARESCAPE ONE or CARESCAPE Patient Data Module (PDM) as patient data acquisition devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.
CARESCAPE Canvas Smart Display 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.
CARESCAPE Canvas Smart Display is not intended for use in an MRI environment.
Indications for Use for CARESCAPE Canvas D19:
CARESCAPE Canvas D19 is intended for use as a secondary display with a compatible host device. It is intended for displaying measurement and parametric data from the host device and providing visual and audible alarms generated by the host device.
CARESCAPE Canvas D19 enables controlling the host device, including starting and discharging a patient case, changing parametric measurement settings, changing alarm limits and disabling alarms.
Using CARESCAPE Canvas D19 with a compatible host device enables real-time multi-parameter patient monitoring and continuous evaluation of the patient's ventilation, oxygenation, hemodynamic, circulation, temperature, and neurophysiological status.
Indications for Use for F2 Frame; F2-01:
The F2 Frame, module frame with two slots, is intended to be used with compatible GE multiparameter patient monitors to interface with two single width parameter modules, CARESCAPE ONE with a slide mount, and recorder.
The F2 Frame is intended for use in multiple areas within a professional healthcare facility. The F2 Frame is intended for use under the direct supervision of a licensed healthcare practitioner, or by person trained in proper use of the equipment in a professional healthcare facility.
The F2 Frame is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223531 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223531: CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223531
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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