# K023832: Surestep Hospital Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Lifescan, Inc.
- Decided: Dec 13, 2002 after 25 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (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® PRO Blood Glucose Monitoring System: named in the summary without a submission number
- (no number) SURESTEP® Blood Glucose Monitoring System: named in the summary without a submission number

## Recalls of this device
- Sep 9, 2005 · Not classified · Z-0101-06: The LCD of the OneTouch SureStep Meter may display incorrectly, resulting in missing segments on the display. This display failure may result in patients misreading the blood glucose result, or cause 

## Indications for use
The SURESTEP Hospital Blood Glucose Monitoring System is for in vitro diagnostic use for the quantitative measurement of glucose in venous, capillary, arterial, and neonatal whole blood samples. Lay users can also use the system to test capillary blood.

Source page: https://510kreport.com/device/K023832
Methodology: https://510kreport.com/methodology