510(k) · Cleared
ClearedDMS 300-7
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Monitoring Software · DSH Recorder, Magnetic Tape, Medical
Cleared on Aug 16, 2006 as substantially equivalent to K923664 (Scole Engineering Co., 1994) and 1 other predicate after a 30-day review. Its family tree reaches back 2 generations to 1992. 2 later devices descend from it.
- Decided
- Aug 16, 2006
- Review
- 30 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K921068 (1992). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK921068 Gikter Ecg Cassette Tape Recorder Model XR 300Datrix · 1992
- 1 generation backK982975 Digital Ecg Holter Recorder, Model DR512Datrix · 1998
- This deviceK062007 DMS 300-7Diagnostic Monitoring Software · 2006
- Descendant · cites it directly · 1 of its ownK062959 DMS 300-2, 300-3 and 300-4Diagnostic Monitoring Software · 2006
- Descendant · 2 generations on · 0 of its ownK133014 DMS 300-2W Holter Ecg RecorderDiagnostic Monitoring Software · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921068 | Gikter Ecg Cassette Tape Recorder Model XR 300 | Datrix | 1992 | — |
| −1 | K982975 | Digital Ecg Holter Recorder, Model DR512 | Datrix | 1998 | — |
| 0 (this device) | K062007 | DMS 300-7 | Diagnostic Monitoring Software | 2006 | — |
| +1 | K062959 | DMS 300-2, 300-3 and 300-4 | Diagnostic Monitoring Software | 2006 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2014 | 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 DSH? 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 DSH device
- #1 K260157 LifeLens Physiological Monitorscore 17.9 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K923664 | Scole 300 Ecg RecorderSummary page 1…for use, functions, and recording output EGG data are the same as the predicate device, Model 300 EGG Recorder. The Final Test results of the predicate 300 ECG Recorder (K923664) and the modified submission device DM3 300-7, show that testing of the device with the same input signals produces the same resu… | 1994 |
| * | K982975 | Digital Ecg Holter Recorder, Model DR512Summary page 1…s that were cleared 510(k)s under 21 CFR 870.2800, Class 11: * Diagnostic Monitoring Software (Scole) 300 EGG Recorder (K923664). * Datrix DR512 Halter Recorder (K982975) Description The modified DMS 300-7 Halter EGG recorder is intended for use as a padt of a Halter analysis system and is desig… | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062959 | DMS 300-2, 300-3 and 300-4 | 2006 | 1 |
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 14 years and passes through 2 companies; a new generation was cleared every 7.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K062959 (Diagnostic Monitoring Software, 2006) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K923664.
How does its category compare?
All DSH devicesDSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSH
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSH
No recall names DSH since 2007.
Adverse event reports per year · DSH
213in 2025
MAUDE reports naming product code DSH, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 84 | 0 | 1 |
| 2010 | 2 | — | 0 | 8 |
| 2011 | 6 | 64 | 0 | 3 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 8 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 3 | 91 | 0 | 31 |
| 2018 | 3 | 269 | 0 | 30 |
| 2019 | 3 | 30 | 0 | 76 |
| 2020 | 4 | 122 | 0 | 91 |
| 2021 | 4 | 263 | 0 | 113 |
| 2022 | 4 | 427 | 0 | 46 |
| 2023 | 6 | 198 | 0 | 65 |
| 2024 | 2 | — | 0 | 88 |
| 2025 | 4 | 205 | 0 | 213 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The DMS 300-7 Holter ECG recorder is intended to acquire, record, and store up to 24-hours of three (3) channel ECG data for patients undergoing continuous ambulatory electrocardiography. The DMS 300-7 performs no cardiac analysis by itself and is intended to be used with the DMS Premier Holter system. In turn, the cardiac data and analysis provided by the Premier Holter system will be reviewed, confirmed, and used by trained medical personnel in the…
Read the full statement (158 words)
The DMS 300-7 Holter ECG recorder is intended to acquire, record, and store up to 24-hours of three (3) channel ECG data for patients undergoing continuous ambulatory electrocardiography. The DMS 300-7 performs no cardiac analysis by itself and is intended to be used with the DMS Premier Holter system. In turn, the cardiac data and analysis provided by the Premier Holter system will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.
The DMS 300-7 is indicated for use in a clinical setting, by qualified medical professionals only, for recording ECG data of patients requiring ambulatory (Holter) monitoring of up to 24-hours. Holter ECG is appropriate for the indications below:
.Evaluation of adult patients with symptons suggesting arrhythmia
.Evaluation of adult patients with pacemakers
.Evaluation of patients with suspected abnormal heart rate changes
.Evaluation of patients with suspected abnormal QRS interval changes
.Evauation of patients with drug therapy treatment
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062007 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062007: DMS 300-7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062007
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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