# K970556: Surestep Pro Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Lifescan, Inc.
- Decided: May 12, 1997 after 88 days
- Product code: CGA (Glucose Oxidase, Glucose)
- 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.
31 later devices descend from it; 2 cite it directly.
2 of 32 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) LifeScan SureStep Blood Glucose Monitoring System: named in the summary without a submission number
- (no number) LifeScan ONE TOUCH II Hospital Blood Glucose Monitoring System: named in the summary without a submission number

## Most influential descendants
- K984261: Surestep Blood Glucose Monitoring System (1999), 15 descendants of its own
- K982303: Precision PCX Point of Care Management System  , QC Manager Data Manager System, Precision G Plus Blood Glucose Test ST (1998), 14 descendants of its own
- K022941: Medisense Precision PCX Point of Care Management System for Blood Glucose Testing (2002), 13 descendants of its own
- K050500: Freestyle 600 Blood Glucose Monitoring System (2005), 12 descendants of its own
- K051839: Free-Style Freedom Blood Glucose Monitoring System, Model 11001 (2006), 10 descendants of its own

## Recalls of this device
- Jan 13, 2003 · Not classified · Z-0630-03: The Test Strips have manufacturing errors, in that the 'Confirmation Dot' is off-center or split in half, and defective bottle Cap.

## Indications for use
The LifeScan SureStepPro blood glucose monitoring system is intended for quantitative measurement of glucose in a sample of whole blood. It can be used in a clinical setting to measure glucose in anterial, venous, and capillary samples in both adults and neonates. It can also be used by lay persons for capillary biood glucose monitoring in the home.

Source page: https://510kreport.com/device/K970556
Methodology: https://510kreport.com/methodology