# K082512: Intelligent Dosing System for Insulin-MY Insulin Doser

- Pathway: 510(k) (Traditional)
- Applicant: Dimensional Dosing Systems, Inc.
- Decided: Nov 7, 2008 after 70 days
- Product code: NDC (Calculator, Drug Dose)
- Device class: 2
- Regulation: 21 CFR 868.1890
- 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 K011571 (2001). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011571: TRXF Intelligent Dosing System (Ids) -Dosing Calculator Suite, The RX Files Corp. (2001) Summary page 1.

## Most influential descendants
- K181916: d-Nav System (2019), 1 descendant of its own
- K253281: UpDoc (2025), 0 descendants of its own
- K163664: Health-e-Connect System with IDA (2017), 0 descendants of its own
- K160949: Go Dose System (2016), 0 descendants of its own

## Indications for use
My Insulin Doser/IDS allows a diabetic patient to calculate the best next dose of insulin to achieve a personal glucose target.

Source page: https://510kreport.com/device/K082512
Methodology: https://510kreport.com/methodology