# K861844: Glucofacts Data Management System

- Pathway: 510(k) (Traditional)
- Applicant: Miles Laboratories, Inc.
- Decided: Aug 12, 1986 after 91 days
- Product code: JQP (Calculator/Data Processing Module, For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 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
- K024234: Ascensia Glucofacts; Ascensia Glucofacts Professional (2003), 6 descendants of its own
- K082486: Glucofacts Express Diabetes Management Software (2008), 5 descendants of its own
- K122142: Glooko Logbook Charts (2012), 3 descendants of its own
- K130886: Glooko Device System for Glooko Logbook+ Application (2013), 2 descendants of its own
- K141862: HEALTH2SYNC Mobile Application, HEALTH2SYNC Smart Cable (2014), 0 descendants of its own

Source page: https://510kreport.com/device/K861844
Methodology: https://510kreport.com/methodology