510(k) · Cleared

Recalled · Class II · 2015

Carescape Monitor B850

K131414510(k) TraditionalCleared Aug 28, 2013104-day reviewClass II21 CFR 870.1025Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

GE Healthcare Finland Oy · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Aug 28, 2013 as substantially equivalent to K092027 (Ge Medical Systems Information Technologies, 2009) after a 104-day review. Its family tree reaches back 5 generations to 2000. 10 later devices descend from it. It has been recalled 3 times.

Decided: Aug 28, 2013
Review: 104 days
Class: Class II
Product code: MHX
Recalls: 3
Predicates: 1

Its longest line of descent runs back 5 generations to K000815 (2000). 12 ancestors in all, the oldest K900598 (1990). 10 later devices descend from it, 2 citing it directly.

By dateBy generation

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 deviceK131414 Carescape Monitor B850GE Healthcare Finland Oy · 2013
Descendant · cites it directly · 7 of its ownK191323 Carescape B850GE Healthcare Finland Oy · 2020 · Recalled
Descendant · cites it directly · 4 of its ownK191249 Carescape B450GE Healthcare Finland Oy · 2020
Descendant · 2 generations on · 3 of its ownK201941 Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc. · 2020
Descendant · 2 generations on · 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

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2020high 3 (2020) · low 0 (2021)2026

Most influential descendants

Showing 5 of 10 · See all

K191323Carescape B850GE Healthcare Finland Oy · 2020 · cites it directly7descendants
K191249Carescape B450GE Healthcare Finland Oy · 2020 · cites it directly4descendants
K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc. · 2020 · 2 generations on3descendants
K213336Carescape B850, E-musbGE Healthcare Finland Oy · 2022 · 2 generations on2descendants
K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc. · 2022 · 2 generations on2descendants

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)	K131414	Carescape Monitor B850	GE Healthcare Finland Oy	2013	—
+1	K191323	Carescape B850	GE Healthcare Finland Oy	2020	1
+1	K191249	Carescape B450	GE Healthcare Finland Oy	2020	—
+2	K201941	Monitor B125, Monitor B105	Ge Medical Systems Information Technologies, Inc.	2020	—
+2	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

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	3	0
2022	3	0
2023	1	0
2024	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K131414, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K092027	Carescape Monitor B850 Summary page 2 …K13 1414 Page 2 of 5 Predicate Device(s) K092027 CARESCAPE Monitor B850 (807.92(a)(3):: Device Description The CARESCAPE Monitor B850 includes both new and existi…	Ge Medical Systems Information Technologies	2009	9
†	K031320	EK-Pro Arrhythmia Detection Algorithm	Ge Medical Systems Information Technologies	2003	—

Also cleared against K092027: 1 other device →

What descends from it? (10)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K191323	Carescape B850	GE Healthcare Finland Oy	2020	7
K191249	Carescape B450	GE Healthcare Finland Oy	2020	4

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
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.
5 of the 12 ancestors have a recall of any class.
Of its descendants, K191323 (GE Healthcare Finland Oy, 2020) has gone furthest, with 7 descendants of its own.
1 other device also cites its predicate K092027.

How does its category compare?

All MHX devices

MHX 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

2007high 21 (2013) · low 5 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MHX

192in 2025

2007high 248 (2014) · low 57 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MHX

21so far in 2026, the most since 2007

2007high 21 (2026) · low 0 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MHX

3,761in 2025

2007high 3,761 (2025) · low 131 (2007)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 B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time The CARESCAPE Monitor B850 is indicated for monitoring of: * hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure…

Read the full statement (216 words)

The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility.

The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time

The CARESCAPE Monitor 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 Monitor B850 also provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices.

The CARESCAPE Monitor 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 Monitor 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.

The CARESCAPE Monitor B850 is not intended for use during MRI.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K131414 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131414: Carescape Monitor B850.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131414

Report an extraction error

Are you the manufacturer?

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