# K022182: Medisense Precision Easyblood Glucose Monitoring System, Medisense Optium Easyblood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Sep 9, 2002 after 68 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- 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: 4 generations back to K945887 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944195: Quickpro Blood Glucose Testing System, Medisense, Inc. (1995) Summary page 1.
- K971812: Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip, Medisense, Inc. (1997) Summary page 1.

## Indications for use
The MediSense Precision Easy / MediSense Oprium Easy Blood Glucose Monitoring System is intended for outside-rhe-body (in-virro diugqosric) use. The system is indicated for the quantirative measilremenr of glucose in fresh whole blood for self-tesring by lay users (e-g., from the finger), or by health care professionals. The MediSense Precision Easy / MediSense Oprium Easy Blood Glucose Monitoring System is to be used for the moniroring of blood glucose concentrations in persons with diabetes and other condirions.

Source page: https://510kreport.com/device/K022182
Methodology: https://510kreport.com/methodology