510(k) · Cleared
Recalled · Class II · 2024Carescape B850
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 29, 2020 as substantially equivalent to K131414 (GE Healthcare Finland Oy, 2013) after a 259-day review. Its family tree reaches back 6 generations to 2000. 7 later devices descend from it. It has been recalled once.
- Decided
- Jan 29, 2020
- Review
- 259 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K000815 (2000). 13 ancestors in all, the oldest K900598 (1990). 7 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 backK131414 Carescape Monitor B850GE Healthcare Finland Oy · 2013 · Recalled
- This deviceK191323 Carescape B850GE Healthcare Finland Oy · 2020
- Descendant · cites it directly · 3 of its ownK201941 Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK213336 Carescape B850, E-musbGE Healthcare Finland Oy · 2022 · Recalled
- Descendant · 2 generations on · 2 of its ownK213490 Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor…Ge Medical Systems Information Technologies, Inc. · 2022 · Recalled
- Descendant · 2 generations on · 1 of its ownK223531 CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE…GE Healthcare Finland Oy · 2023 · Recalled
- Descendant · 3 generations on · 0 of its ownK260343 Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland Oy · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc. · 2020 · cites it directly3descendants
- K213336Carescape B850, E-musbGE Healthcare Finland Oy · 2022 · cites it directly2descendants
- K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc. · 2022 · 2 generations on2descendants
- K223531CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame…GE Healthcare Finland Oy · 2023 · 2 generations on1descendant
- K260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland Oy · 2026 · 3 generations on0descendants
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 | K131414 | Carescape Monitor B850 | GE Healthcare Finland Oy | 2013 | 3 |
| 0 (this device) | K191323 | Carescape B850 | GE Healthcare Finland Oy | 2020 | — |
| +1 | K201941 | Monitor B125, Monitor B105 | Ge Medical Systems Information Technologies, Inc. | 2020 | — |
| +1 | K213336 | Carescape B850, E-musb | GE Healthcare Finland Oy | 2022 | 1 |
| +2 | K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2022 | 6 |
| +2 | K223531 | CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19… | GE Healthcare Finland Oy | 2023 | 3 |
| +3 | 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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K131414 | Carescape Monitor B850Summary page 7…GWJ, GWQ, KOI, KRB, MLD, NHO, NHP, NHQ, OLT, OLW, OMC, ORT Predicate Device(s) (807.92(a)(3): K131414 CARESCAPE Monitor B850 Device Description CARESCAPE B850 V3 is a new version of a modular multi- (807.92… | 2013 |
| † | K150245 | CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX | 2015 |
What descends from it? (7)
2 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 |
|---|---|---|---|---|
| Apr 5, 2024 | Class II | Z-2170-2024 | 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 3.6 years on median.
- 6 of the 13 ancestors have a recall of any class.
- Of its descendants, K201941 (Ge Medical Systems Information Technologies, Inc., 2020) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K131414.
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 B850 is a multi-parameter patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B850 is indicated for monitoring of: ● hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse…
Read the full statement (275 words)
The CARESCAPE B850 is a multi-parameter patient monitor intended for use in multiple areas within a professional healthcare facility.
The CARESCAPE B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.
The CARESCAPE B850 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 B850 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 B850 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 B850 also shows alarms from other ECG sources.
The CARESCAPE B850 also provides other alarms, trends, snapshots and events, and calculations, and can be connected to displays, printers and recording devices.
The CARESCAPE 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.
Contraindications for using the monitor
The CARESCAPE B850 is not intended for use in a controlled MR environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191323 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191323: Carescape B850.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191323
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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