# K011999: Modification to Flexview Clinical Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Data Critical Corp.
- Decided: Jul 24, 2001 after 27 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- 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: 1 generation back to K003998 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003998: Flexview Clinical Monitoring System, Data Critical Corp. (2001) Summary page 1.

## Indications for use
The FlexView™ Clinical Monitoring System is intended for use as a secondary annunciation of compatible primary medical device alarms. The FlexView™ Clinical Monitoring System is for use as an accessory to primary medical devices and is currently compatible with pulse oximeters, infusion pumps and ventilators. The FlexView™ Clinical Monitoring System is to supplement and not replace any part of the current primary medical device monitoring procedure. The FlexView™ Clinical Monitoring System is for use by healthcare professionals trained in the use of the primary medical devices that are being monitored. The FlexView™ Clinical Monitoring System is not considered to be diagnostic without skilled interpretation and does not replace physician’s care. The FlexView™ Clinical Monitoring System is for use with patient populations being monitored by healthcare professionals utilizing compatible pulse oximeters, infusion pumps and ventilators. The FlexView™ Clinical Monitoring System is for use in healthcare facilities such as hospitals, outpatient clinics or free standing surgical centers.

Source page: https://510kreport.com/device/K011999
Methodology: https://510kreport.com/methodology