# K990939: Fasttake Compact Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Selfcare, Inc.
- Decided: Apr 20, 1999 after 29 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K945887 (1995). 3 ancestors in all.
1 later device descends 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)
- K970707: Elect II Blood Glucose Monitoring System, Selfcare, Inc. (1997) Summary page 1.

## Most influential descendants
- K993632: Fasttake Compact Blood Glucose Monitoring System (1999), 0 descendants of its own

## Indications for use
The FastTake® Compact Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The FastZake® System is intended for use outside the body (in vitro diagnostic use) by diabetics at home as an aid to monitor the effectiveness of diabetes control.

Source page: https://510kreport.com/device/K990939
Methodology: https://510kreport.com/methodology