# K101969: MH1 Microholter Recorder

- Pathway: 510(k) (Traditional)
- Applicant: Exelys, LLC
- Decided: Feb 4, 2011 after 206 days
- Product code: MWJ (Electrocardiograph, Ambulatory (Without Analysis))
- Device class: 2
- Regulation: 21 CFR 870.2800
- 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 K071733 (2007). 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)
- K071733: DL900 Series Holter Recorder, Braemar, Inc. (2007) Summary page 2.

## Indications for use
The MII Microolter Recorder is intended for patients requiring ambulatory (Holter) monitoring. Such monitoring is most frequently used for the following indications: * Evaluation of symptoms suggesting arrhythmia or myocardial ischemnia. * Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients. * Evaluation of patients for ST segment changes. * Evaluation of a patient's response after resuming occupational or recreational activities (e.g. after M.I. or cardiac surgery). * Clinical and epidemiological research studies. * Evaluation of patients with pacemakers. * Indication of time and frequency domain headt rate variability. *Evaluation of patient for QT interval.

Source page: https://510kreport.com/device/K101969
Methodology: https://510kreport.com/methodology