# K073407: Pacifica

- Pathway: 510(k) (Traditional)
- Applicant: Or-Nim Medical, Ltd.
- Decided: Feb 28, 2008 after 86 days
- Product code: MUD (Oximeter, Tissue Saturation)
- Device class: 2
- Regulation: 21 CFR 870.2700
- 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 K931154 (1993). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051274: Invos System, Somanetics Corp. (2005)
- K051257: Adult Cerebral Oximeter, Model 2040, Cas Medical Systems, Inc. (2005)
- K061619: Inspectra STO2 Tissue Oxygenation Monitor, Hutchinson Technology, Inc. (2006) Summary page 1.

## Most influential descendants
- K093923: Cerox Model 3210 (2010), 0 descendants of its own

## Indications for use
The noninvasive Or-Nim Pacifica Model 01 is intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain of an adult. It is also intended for use as an adjunct monitor of hemoglobin oxygen saturation of blood in a region of skeletal muscle tissue beneath the sensor in adults. The prospective clinical value of data from the Pacifica monitor has not been demonstrated in disease states. The Pacifica monitor should not be used as the sole basis for diagnosis or therapy.

Source page: https://510kreport.com/device/K073407
Methodology: https://510kreport.com/methodology