# K984261: Surestep Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Lifescan, Inc.
- Decided: May 21, 1999 after 175 days
- Product code: CGA (Glucose Oxidase, Glucose)
- 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: 1 generation back to K942455 (1995). 2 ancestors in all.
15 later devices descend from it; 8 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942455: Lifescan Surestep Blood Glucose Monitoring System, Lifescan, Inc. (1995) Summary page 1.
- K970556: Surestep Pro Blood Glucose Monitoring System, Lifescan, Inc. (1997) Summary page 1.

## Most influential descendants
- K051285: Glucolab Blood Glucose Monitoring System (2005), 6 descendants of its own
- K091157: Gluco Lab Auto Coding, Model Igm-0022 (2009), 2 descendants of its own
- K113192: Healthpro Blood Glucose Monitoring System (2012), 1 descendant of its own
- K082201: G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024A (2009), 1 descendant of its own
- K052469: Glucopack (2006), 1 descendant of its own

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

Source page: https://510kreport.com/device/K984261
Methodology: https://510kreport.com/methodology