# K002134: One Touch Ultra Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Selfcare, Inc.
- Decided: Aug 7, 2000 after 24 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.
73 later devices descend from it; 10 cite it directly.
0 of 74 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
- K021819: One Touch Ultrasmart Blood Glucose Monitoring System (2002), 26 descendants of its own
- K072369: Evolution Blood Glucose Monitoring System (2008), 21 descendants of its own
- K090057: ON-Call Plus Blood Glucose Monitoring System (2009), 17 descendants of its own
- K113332: ON Call Chosen Lancing Device (2012), 16 descendants of its own
- K081703: Myglucohealth Glucose Monitoring Systems (2009), 10 descendants of its own

Source page: https://510kreport.com/device/K002134
Methodology: https://510kreport.com/methodology