# K993632: Fasttake Compact Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Selfcare, Inc.
- Decided: Nov 12, 1999 after 16 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: 3 generations back to K945887 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990939: Fasttake Compact Blood Glucose Monitoring System, Selfcare, Inc. (1999) Summary page 1.

## 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 FastTake® 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/K993632
Methodology: https://510kreport.com/methodology