# K942455: Lifescan Surestep Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Lifescan, Inc.
- Decided: Mar 24, 1995 after 305 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
No predicates in its family tree.
16 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K984261: Surestep Blood Glucose Monitoring System (1999), 15 descendants of its own
- 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

Source page: https://510kreport.com/device/K942455
Methodology: https://510kreport.com/methodology