510(k) · Cleared
ClearedDMS 300-2W Holter Ecg Recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Monitoring Software · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on May 19, 2014 as substantially equivalent to K062959 (Diagnostic Monitoring Software, 2006) after a 236-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- May 19, 2014
- Review
- 236 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K921068 (1992). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK921068 Gikter Ecg Cassette Tape Recorder Model XR 300Datrix · 1992
- 3 generations backK982975 Digital Ecg Holter Recorder, Model DR512Datrix · 1998
- 2 generations backK062007 DMS 300-7Diagnostic Monitoring Software · 2006
- 1 generation backK062959 DMS 300-2, 300-3 and 300-4Diagnostic Monitoring Software · 2006
- This deviceK133014 DMS 300-2W Holter Ecg RecorderDiagnostic Monitoring Software · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921068 | Gikter Ecg Cassette Tape Recorder Model XR 300 | Datrix | 1992 | — |
| −3 | K982975 | Digital Ecg Holter Recorder, Model DR512 | Datrix | 1998 | — |
| −2 | K062007 | DMS 300-7 | Diagnostic Monitoring Software | 2006 | — |
| −1 | K062959 | DMS 300-2, 300-3 and 300-4 | Diagnostic Monitoring Software | 2006 | — |
| 0 (this device) | K133014 | DMS 300-2W Holter Ecg Recorder | Diagnostic Monitoring Software | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MWJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MWJ device
- #1 K254119 Wearable ECG Recorder (YMHeart XY-12)…score 14.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062959 | DMS 300-2, 300-3 and 300-4Summary page 2…. Hazard Risk Analysis. 10. Pictures. Legally 510(k) marketed device to which Substantial Equivalence is claimed: In October 2006, the FDA issued its 510(k) number K062959 for the DM5I Halter Recorder, Model 300-2, which is the predicate device for this submission. The Regulation Number was 21 CFR 87… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 7.6 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All MWJ devicesMWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MWJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MWJ
337in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWJ
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWJ
8in 2025
MAUDE reports naming product code MWJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 142 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 3 | 90 | 0 | 0 |
| 2011 | 3 | 206 | 0 | 0 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 3 | 241 | 0 | 4 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 4 | 337 | 0 | 6 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 2 | — | 2 | 3 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 5 | 270 | 0 | — |
What is it indicated for?
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…
Read the full statement (119 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133014 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133014: DMS 300-2W Holter Ecg Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133014
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026