# K133014: DMS 300-2W Holter Ecg Recorder

- Pathway: 510(k) (Special)
- Applicant: Diagnostic Monitoring Software
- Decided: May 19, 2014 after 236 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: 4 generations back to K921068 (1992). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062959: DMS 300-2, 300-3 and 300-4, Diagnostic Monitoring Software (2006) Summary page 2.

## Indications for use
The "Indications for Use" of the modified 300-2W recorder are indicated for use in a clinical setting, by qualified medical professionals only, for recording multi-lead ECG data of patients during a minimum ambulatory time period of 24-hours. It is not a life support system, and is not connected to an AC power source. The "Indications for Use" of the modified 300-2W are exactly the same as the predicate devices (DMS 300-2 and 300-7). Ambulatory multi-day electrocardiography is used for the below indications: - Evaluation of patients with symptoms suggesting arrhythmias - Evaluation of patients with pacemakers - Evaluation of patient heart rate changes - Evaluation of patient QRS interval changes - Evaluation of patient response to drug therapy treatment

Source page: https://510kreport.com/device/K133014
Methodology: https://510kreport.com/methodology