# K073203: Carescape V100

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Nov 29, 2007 after 16 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K962603 (1997). 38 ancestors in all.
20 later devices descend from it; 2 cite it directly.
3 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022193: Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400N, Ge Medical Systems Information Technologies (2002) Summary page 1.
- K022834: Dinamap Pro 1000 Monitor with Superstat, Model 1000, Ge Medical Systems Information Technologies (2003) Summary page 1.
- K040831: Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500, Datex-Ohmeda, Inc. (2004) Summary page 1.

## Most influential descendants
- K102426: Carescape Model V100 Vital Signs Monitor (2010), 11 descendants of its own
- K120598: Procare Monitor B40 (2012), 10 descendants of its own
- K130584: Monitor B40 (2013), 8 descendants of its own
- K133576: Monitor B40 (2014), 7 descendants of its own
- K151063: Monitor B40 (2015), 5 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/K073203
Methodology: https://510kreport.com/methodology