# K023194: Suresteppro/Surestepflexx Professional Blood Glucose Management System

- Pathway: 510(k) (Special)
- Applicant: Lifescan, Inc.
- Decided: Oct 24, 2002 after 29 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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 PRO Blood Glucose Monitoring System: named in the summary without a submission number

## Most influential descendants
- K113314: Precichek NS-101 Poct Professional Blood Glucose Monitoring System (2012), 0 descendants of its own

## Recalls of this device
- Feb 24, 2010 · Not classified · Z-2028-2010: Products may provide inaccurate results at readings over 400 mg/dL
- Sep 29, 2006 · Not classified · Z-0453-2007: Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results.

## Indications for use
The SURESTEP PRO and the SURESTEP FLEXX Professional Blood Glucose Management Systems are for in vitro diagnostic use for the quantitative measurement of glucose in venous, capillary, arterial and neonatal whole blood samples. These systems can also be used by lay users at home.

Source page: https://510kreport.com/device/K023194
Methodology: https://510kreport.com/methodology