# K090249: Modification to: Micro-Induction 1000 System

- Pathway: 510(k) (Special)
- Applicant: Harbinger Medical, Inc.
- Decided: Apr 3, 2009 after 60 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K930806 (1994). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013615: Micro-Induction 1000 System, Harbinger Medical, Inc. (2002) Summary page 1.

## Indications for use
The MI-I000 is used to measure Wavelet Surface Residuum indices at rest and during low level electrical stimulation during the cardiac refractory period. This data is presented in a graphical format for interpretation by a trained physician. The MI- 1000 is also used for the measurement of SAECG indices. The MI- 1000 should be used only as an adjunct to clinical history and the results of other noninvasive and/or invasive tests.

Source page: https://510kreport.com/device/K090249
Methodology: https://510kreport.com/methodology