510(k) · Cleared
ClearedCarescape One
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Dec 20, 2019 as substantially equivalent to K071073 (Ge Medical Systems Information Technologies, 2007) and 1 other predicate after a 352-day review. Its family tree reaches back 7 generations to 2000. 11 later devices descend from it.
- Decided
- Dec 20, 2019
- Review
- 352 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K000815 (2000). 22 ancestors in all, the oldest K900598 (1990). 11 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 backK132533 Carescape Monitor B450GE Healthcare Finland Oy · 2013 · Recalled
- This deviceK190008 Carescape OneGE Healthcare · 2019
- Descendant · cites it directly · 10 of its ownK200494 CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP…GE Healthcare · 2020 · Recalled
- Descendant · 2 generations on · 3 of its ownK213234 CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and…Ge Medical Systems Information Technologies, Inc. · 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 · 2 of its ownK212876 Carescape SpO2 - MasimoMasimo Corporation · 2021
- Descendant · 2 generations on · 1 of its ownK223498 Radius VSM and AccessoriesMasimo Corporation · 2023 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K200494CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRESGE Healthcare · 2020 · cites it directly10descendants
- K213234CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG…Ge Medical Systems Information Technologies, Inc. · 2022 · 2 generations on3descendants
- K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc. · 2022 · 2 generations on2descendants
- K212876Carescape SpO2 - MasimoMasimo Corporation · 2021 · 2 generations on2descendants
- K223498Radius VSM and AccessoriesMasimo Corporation · 2023 · 2 generations on1descendant
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 | K132533 | Carescape Monitor B450 | GE Healthcare Finland Oy | 2013 | 3 |
| 0 (this device) | K190008 | Carescape One | GE Healthcare | 2019 | — |
| +1 | K200494 | CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE… | GE Healthcare | 2020 | 1 |
| +2 | K213234 | CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101… | Ge Medical Systems Information Technologies, Inc. | 2022 | 1 |
| +2 | K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2022 | 6 |
| +2 | K212876 | Carescape SpO2 - Masimo | Masimo Corporation | 2021 | — |
| +2 | K223498 | Radius VSM and Accessories | Masimo Corporation | 2023 | 2 |
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 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K071073 | Solar 8000 and Transport Pro with Patient Data ModuleSummary page 5…s: BZQ, CCK, DPS, DPZ, DQA, DQK, DRT, DSI, DSJ, DSK, DXN, FLL, MLD Predicate Device(s) The primary predicate for this submission is K071073, Patient (807.92(a)(3)): Data Module (PDM) Additional predicates/reference devices:… | 2007 |
| * | K132533 | Carescape Monitor B450Summary page 5…is K071073, Patient (807.92(a)(3)): Data Module (PDM) Additional predicates/reference devices: K132533 CARESCAPE Monitor B450 K022834 Pro1000 K080251 APEXPRO TELEMETRY SYST… | 2013 |
| † | K022834 | Dinamap Pro 1000 Monitor with Superstat, Model 1000 | 2003 |
| † | K080251 | Apexpro Telemetry Systems | 2008 |
| † | K011000 | Tram 2001 Module | 2001 |
| † | K051367 | Patient Monitor, Models Dash 3000, 4000 and 5000 | 2005 |
| † | K900598 | Tramscope System | 1990 |
| † | K171580 | Monitor B125, Monitor B105 | 2017 |
| † | K151063 | Monitor B40 | 2015 |
| † | K110028 | Masimo Radical Y Pulse CO-Oximeter | 2011 |
| † | K172482 | The Nellcor pulse oximetry monitor interface cable | 2017 |
| † | K053174 | Loflo C5 CO2 Sensor | 2006 |
| † | K083750 | Capnostat / Capnoflex CO2 System | 2009 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200494 | CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES | 2020 | 10 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 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, K200494 (GE Healthcare, 2020) has gone furthest, with 10 descendants of its own.
- 4 other devices also cite its predicate K071073.
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. 2019, 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 ONE is a multi-parameter physiological patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE ONE is indicated for the monitoring of hemodynamic (including ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, and temperature), and respiratory (impedance respiration and CO2 airway gas) physiological…
Read the full statement (157 words)
The CARESCAPE ONE is a multi-parameter physiological patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility.
The CARESCAPE ONE is indicated for the monitoring of hemodynamic (including ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, and temperature), and respiratory (impedance respiration and CO2 airway gas) physiological parameters.
The CARESCAPE ONE provides ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, temperature, impedance respiration, and CO2 airway gas parameter acquisition and monitoring.
The CARESCAPE ONE is indicated for use on adult, pediatric, and neonatal patients and on one patient at a time.
The CARESCAPE ONE is indicated for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in the proper use of the equipment in a professional healthcare facility.
Contraindications for using CARESCAPE ONE:
The CARESCAPE ONE is not intended for use within a controlled MR environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190008: Carescape One.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190008
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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