# K130294: Braemar Cardiokey Holter Recorder

- Pathway: 510(k) (Special)
- Applicant: Braemar Manufacturing, LLC
- Decided: Oct 16, 2013 after 252 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 1.

## Indications for use
The CK100 CardioKey Holter Recorder is intended for patients requiring ambulatory (Holter) Monitoring. The following is a listing of the most frequent indications for use: 1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia. 2. Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients. 3. Evaluation of patients for ST segment changes. 4. Evaluation of a patients response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.) 5. Clinical and epidemiological research studies. 6. Reporting of time and frequency domain heart rate variability. 7. Reporting of QT Interval.

Source page: https://510kreport.com/device/K130294
Methodology: https://510kreport.com/methodology