# K071733: DL900 Series Holter Recorder

- Pathway: 510(k) (Special)
- Applicant: Braemar, Inc.
- Decided: Jul 24, 2007 after 28 days
- Product code: MWJ (Electrocardiograph, Ambulatory (Without Analysis))
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K130294: Braemar Cardiokey Holter Recorder (2013), 0 descendants of its own
- K101969: MH1 Microholter Recorder (2011), 0 descendants of its own

## Recalls of this device
- Jan 22, 2020 · Class II · Z-1460-2020: An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This issue can prevent the recorder from operating normally. Braemar confirmed that beginning on January 1, 
- Jan 22, 2020 · Class II · Z-1459-2020: An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This issue can prevent the recorder from operating normally. Braemar confirmed that beginning on January 1, 
- Jan 13, 2020 · Class II · Z-1345-2020: if an AAA battery is inserted in the recorder and a user attempts to start it, or if the recorder is inserted in the docking station, the recorder will display Error: 602 and fail to function for a ne

## Indications for use
The DL900 Series Hotter Recorder is intended for patients requiring ambulatory (Holter) monitoring. Such monitoring is most frequently used for the indications below: 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 patient's response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.) 5. Clinical and epidemiological research studies. 6. Evaluation of patients with pacemakers. 7. Reporting of time and frequency domain heart rate variability. 8. Reporting of QT Interval

Source page: https://510kreport.com/device/K071733
Methodology: https://510kreport.com/methodology