# K022724: Surestep Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Lifescan, Inc.
- Decided: Sep 12, 2002 after 27 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SURESTEP Blood Glucose Monitoring System: named in the summary without a submission number

## Recalls of this device
- Feb 24, 2010 · Not classified · Z-2027-2010: Products may provide inaccurate results at readings over 400 mg/dL
- Nov 25, 2008 · Not classified · Z-1070-2009: Deformity in the test strip may result in insufficient blood transfer to reaction area, resulting in inaccurate test results.
- Sep 29, 2006 · Not classified · Z-0452-2007: Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results.

## Indications for use
The SURESTEP System is for quantitative measurement of glucose in whole blood. It may be used by persons with diabetes in the home and by healthcare professionals in clinical settings as an aid to monitor effectiveness of diabetes control.

Source page: https://510kreport.com/device/K022724
Methodology: https://510kreport.com/methodology