# K162042: OptiScanner 5000 Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Optiscan Biomedical Corp.
- Decided: Oct 16, 2017 after 448 days
- Product code: LZF (Pump, Infusion, Analytical Sampling)
- Device class: 2
- Regulation: 21 CFR 880.5725
- 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 K951739 (1996). 1 ancestor in all.
1 later device descends 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)
- K951739: Pump/Blood Chemistry Monitor, Via Medical Corp. (1996) Summary page 5.

## Most influential descendants
- K192785: OptiScanner® 5000 Glucose Monitoring System (2020), 0 descendants of its own

## Indications for use
The OptiScanner® 5000 Glucose Monitoring System is an automated, bedside glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) in the surgical intensive care unit. The system collects a venous whole blood sample via connection to a central venous catheter, centrifuges the sample, and measures the plasma glucose concentration. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. The OptiScanner® 5000 Glucose Monitoring System is for in vitro diagnostic use.

Source page: https://510kreport.com/device/K162042
Methodology: https://510kreport.com/methodology