# K911755: Control for PH,Blood Gases,Eletrolytes,Glucose

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: May 22, 1991 after 34 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

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

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K974822: Avl Opti-Check PH/ Blood Gas/ Electrolyte/THB/ SO2 Control (1998), 1 descendant of its own
- K053327: Oxicom Control (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K911755
Methodology: https://510kreport.com/methodology