510(k) · Cleared
ClearedDM-400 Holter Ecg Cassette Recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Monitoring · DSH Recorder, Magnetic Tape, Medical
Cleared on Aug 20, 1997 as substantially equivalent to K921068 (Datrix, 1992) and 1 other predicate after a 205-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Aug 20, 1997
- Review
- 205 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K921068 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK921068 Gikter Ecg Cassette Tape Recorder Model XR 300Datrix · 1992
- This deviceK970298 DM-400 Holter Ecg Cassette RecorderDiagnostic Monitoring · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921068 | Gikter Ecg Cassette Tape Recorder Model XR 300 | Datrix | 1992 | — |
| 0 (this device) | K970298 | DM-400 Holter Ecg Cassette Recorder | Diagnostic Monitoring | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 |
|---|---|---|---|
| * | K921068 | Gikter Ecg Cassette Tape Recorder Model XR 300Summary page 1…corder b. Classification Name: Medical Magnetic Tape Recorder 19.3 IDENTIFICATION OF PREDICATE DE‘VICE(S)" Company Device 510(k) No. Date Cleared Datrix XR-300 Holter K921068 March 30,1992 ECG Recorder Zymed MultiTrak Ambulatory K9308%94 November 11, 1993 ECG Recorder 19.4 19.6 19.7… | 1992 |
| * | K930894 | Multitrak-Plus | 1993 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K921068.
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 DM-400 Holter ECG Cassette Recorder is a device designed for ECG recording of an ambulatory patient.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970298 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970298: DM-400 Holter Ecg Cassette Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970298
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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