# K011616: Induo Blood Glucose Meter

- Pathway: 510(k) (Special)
- Applicant: Inverness Medical Innovations, Inc.
- Decided: Jun 21, 2001 after 27 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- 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 K002134 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002134: One Touch Ultra Blood Glucose Monitoring System, Selfcare, Inc. (2000) Summary page 1.

## Indications for use
The InDuo™ Blood Glucose Meter is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The InDuo™ Blood Glucose Meter is intended for use outside the body (in vitro diagnostic use) by healthcare professionals and by diabetics at home as an aid to monitor the effectiveness of diabetes control. The InDuo™ Blood Glucose Meter also functions as the cap for the InDuo™ Insulin Doser. The two devices fit together to form a single unit for user convenience.

Source page: https://510kreport.com/device/K011616
Methodology: https://510kreport.com/methodology