# K051145: Critiview

- Pathway: 510(k) (Traditional)
- Applicant: Critisense, Ltd.
- Decided: Jan 18, 2006 after 259 days
- Product code: DPW (Flowmeter, Blood, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.2100
- 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 K992529 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992529: Tissue Spectroscope, Vital Medical, Ltd. (2000) Summary page 1.

## Most influential descendants
- K062977: Critiview, Model CRV3 (2007), 0 descendants of its own

## Indications for use
CritiView is indicated for in-vivo monitoring of changes in NADH redox state and microvascular perfusion in tissue. Changes in the measured parameters, blood flow change, blood volume change, and NADH concentration change provide information on tissue metabolic activity. The CritiView uses a pencil style probe which is in contact with the tissue(s) to be measured / monitored. The device may be used for up to eight (8) hours per twenty-four (24) hour period. Tissues which may be monitored are: brain, liver, kidney, intestine, testis, skin. Note that heart may not be used, as the heart beating motion may not provide a reliable probe contact surface. Environment of use include - hospital - OR, ICU, Emergency Departments, High Dependency Units Institutions

Source page: https://510kreport.com/device/K051145
Methodology: https://510kreport.com/methodology