# K062977: Critiview, Model CRV3

- Pathway: 510(k) (Traditional)
- Applicant: Critisense, Ltd.
- Decided: Feb 28, 2007 after 152 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: 2 generations back to K992529 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051145: Critiview, Critisense, Ltd. (2006) Summary page 1.
- K923538: Mon-a-Therm Foley Kit, Mallinckrodt Medical (1993) Summary page 1.

## Indications for use
The CritiView Device 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. Tissues which may be monitored are: brain, liver, kidney, intestine, testis, skin, and urethra. Note that heart may not be used as the heart beating motion may not provide a reliable probe contact surface. Duration of Use: The CritiView has two probes--a pencil style probe and a Foley catheter probe-- which are in contact with the tissue to be measured / monitored. The optical portion of the probe (device) may be used continuously for up to eight (8) hours per twenty-four (24) hour period. The Foley catheter can be left in place up to five (5) days. Patient Population: Pencil Style Probe: Neonate/infant, pediatric, and adult Foley Catheter Probe: Hospitalized adults who are clinically indicated for a Foley catheter use. Environment of use: Hospital - OR, ICU, Emergency Departments, High Dependency Units Institutions Contraindications: The Criti View should not be used on people that are hypersensitive to UV radiation. The device should not be used on patients taking photosensitizing drugs. When monitoring the urethral wall tissue the device should not be used on patients with urinary tract or bladder infection or in any case when the patient clinical condition prevents the use of a Foley catheter.

Source page: https://510kreport.com/device/K062977
Methodology: https://510kreport.com/methodology