# K020967: Terumo Khuri Myocardial PH Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Jun 20, 2002 after 87 days
- Product code: CBZ (Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling)
- Device class: 2
- Regulation: 21 CFR 868.1170
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K862114 (1986). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K862114: Khuri Regional Tissue PH Monitor, Vascular Technology Incorporated (1986) Summary page 1.

## Most influential descendants
- K130079: Multi-Parameter Mobile Careguide 3100 Oximeter (2013), 2 descendants of its own
- K133923: Multi-Parameter Mobile Careguide 3100 Oximeter with Tablet (2014), 1 descendant of its own
- K141496: Multi-Parameter Mobile Careguide 4100 Oximeter (2014), 0 descendants of its own

## Recalls of this device
- Jun 23, 2006 · Not classified · Z-1517-06: Lack of Assurance of Sterility: these specific lots of sensors lack supporting documentation for sterilization assurance.

## Indications for use
The Terumo KhuriTMMyocardial pH Monitoring System is intended for use in monitoring local tissue pH and temperature, typically during procedures in which specific tissues may be subjected to conditions which may result in ischemia, such as the myocardium, during cardiac operations. These parameters are displayed at 37°C corrected value. For documentation purposes, the integral printer provides a hard copy of displayed parameter.

Source page: https://510kreport.com/device/K020967
Methodology: https://510kreport.com/methodology