# K973742: Sendx 100 PH, Blood Gas and Electrolyte Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Sendx Medical, Inc.
- Decided: Dec 3, 1997 after 63 days
- Product code: CGZ (Electrode, Ion-Specific, Chloride)
- Device class: 2
- Regulation: 21 CFR 862.1170
- 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 K874832 (1988). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903965: Statpal Blood Gas Monitoring System, Ppg Industries, Inc. (1990) Summary page 3.
- K914560: Stat Pal Sensyr Syringe Assembly for Use W/Statpal, Ppg Industries, Inc. (1991) Summary page 3.
- K922631: Statpal II Blood Gas Analysis System, Ppg Industries, Inc. (1992) Summary page 3.
- K934907: 860 Measurment System, Ciba Corning Diagnostics Corp. (1994) Summary page 3.
- K910305: Gem-Premier System, Mallinckrodt Sensor Systems, Inc. (1991) Summary page 3.
- K874832: Nova Stat Profile 5 Analyzer + Quality Control, Nova Biomedical Corp. (1988) Summary page 3.

## Indications for use
The SenDx 100™ pH, Blood Gas and Electrolyte Analysis System (SenDx 100™) is intended to measure blood oxygen, carbon dioxide, pH, sodium, potassium, chloride, ionized calcium and hematocrit in whole blood. The SenDx 100™ system can be used in the laboratory, near patient, or in point-of-care settings. It is intended for the measurement of blood gases, electrolytes and hematocrit in arterial or venous whole blood samples. The SenDx 100™ pH, Blood Gas and Electrolyte Analysis System (SenDx 100™) is intended to measure blood oxygen, carbon dioxide, pH, sodium, potassium, chloride, ionized calcium and hematocrit in whole blood. The SenDx 100™ system can be used in the laboratory, near patient, or in point-of-care settings. It is intended for the measurement of blood gases, electrolytes and hematocrit in arterial or venous whole blood samples.

Source page: https://510kreport.com/device/K973742
Methodology: https://510kreport.com/methodology