# K102426: Carescape Model V100 Vital Signs Monitor

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Oct 20, 2010 after 56 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K962603 (1997). 41 ancestors in all.
11 later devices descend from it; 3 cite it directly.
2 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073203: Carescape V100, Ge Medical Systems Information Technologies (2007) Summary page 1.
- K011291: Temporalscanner Thermometer, Sensortouch, Exergen Corp. (2001)
- K050230: Turbo Temp Trio, Cardinal Health, Alaris Products (2005) Summary page 1.

## Most influential descendants
- K151071: SmartLinx Vitals Plus Patient Monitoring System (2015), 3 descendants of its own
- K133810: VC150 Vital Signs Monitor (2014), 3 descendants of its own
- K213490: Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P (2022), 2 descendants of its own
- K171751: SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module (2017), 2 descendants of its own
- K152659: V10 (2016), 2 descendants of its own

## Indications for use
The CARESCAPE V100 Vital Signs Monitor is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital transport. Vital signs parameters include non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, and/or oxygen saturation (pulse oximetry) and/or temperature. The portable device is designed for use in numerous clinical settings in various hospital departments such as emergency, radiology, recovery, medical/surgical, labor and delivery, endoscopy, cardiac step-down. The CARESCAPE V100 Vital Signs Monitor can also be used in satellite areas, physicians' office, or alternate care settings.

Source page: https://510kreport.com/device/K102426
Methodology: https://510kreport.com/methodology