# K994346: Abl 77 PH, Blood Gas and Electrolyte Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Sendx Medical, Inc.
- Decided: Feb 1, 2000 after 40 days
- Product code: CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph)
- Device class: 2
- Regulation: 21 CFR 862.1120
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K051804: ABL80 Flex Analyzer (2005), 2 descendants of its own
- K080370: Abl 80 CO-OX System (2008), 1 descendant of its own
- K151856: ABL80 FLEX CO-OX with AQURE connectivity (2015), 0 descendants of its own

## Recalls of this device
- Jun 19, 2007 · Not classified · Z-1173-2007: Error in the Ca12 calibration value for pCO2 recorded in the cal pack barcode for lot 17323. This error will result in falsely elevated pCO2 results at the high end of the measuring range.

## Indications for use
The ABL 77 pH, Blood Gas and Electrolyte Analysis System is intended to measure blood oxygen, carbon dioxide, pH, sodium, potassium, chloride, ionized calcium and hematocrit in whole blood. The ABL 77 pH, Blood Gas and Electrolyte Analysis System can be used in the laboratory, near patient, or point-of-care settings. It is intended for the measurement of blood gases, electrolytes and hematocrit in arterial and venous whole blood samples.

Source page: https://510kreport.com/device/K994346
Methodology: https://510kreport.com/methodology