510(k) · Cleared
ClearedDigital Ecg Holter Recorder, Model DR512
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datrix · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on Nov 10, 1998 as substantially equivalent to K921068 (Datrix, 1992) and 1 other predicate after a 76-day review. Its family tree reaches back 1 generation to 1992. 5 later devices descend from it.
- Decided
- Nov 10, 1998
- Review
- 76 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K921068 (1992). 2 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK921068 Gikter Ecg Cassette Tape Recorder Model XR 300Datrix · 1992
- This deviceK982975 Digital Ecg Holter Recorder, Model DR512Datrix · 1998
- Descendant · cites it directly · 2 of its ownK062007 DMS 300-7Diagnostic Monitoring Software · 2006
- Descendant · 2 generations on · 1 of its ownK062959 DMS 300-2, 300-3 and 300-4Diagnostic Monitoring Software · 2006
- Descendant · cites it directly · 1 of its ownK031074 Digital Ambulatory Ecg (Holter) RecorderDatrix · 2003
- Descendant · 3 generations on · 0 of its ownK133014 DMS 300-2W Holter Ecg RecorderDiagnostic Monitoring Software · 2014
- Descendant · 2 generations on · 0 of its ownK112601 Intricon Datrix Sirona Event/ Holter RecorderIntricon Datrix Corporation · 2011
Most influential descendants
Showing 5 of 5 · See all- K062007DMS 300-7Diagnostic Monitoring Software · 2006 · cites it directly2descendants
- K062959DMS 300-2, 300-3 and 300-4Diagnostic Monitoring Software · 2006 · 2 generations on1descendant
- K031074Digital Ambulatory Ecg (Holter) RecorderDatrix · 2003 · cites it directly1descendant
- K133014DMS 300-2W Holter Ecg RecorderDiagnostic Monitoring Software · 2014 · 3 generations on0descendants
- K112601Intricon Datrix Sirona Event/ Holter RecorderIntricon Datrix Corporation · 2011 · 2 generations on0descendants
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) | K982975 | Digital Ecg Holter Recorder, Model DR512 | Datrix | 1998 | — |
| +1 | K062007 | DMS 300-7 | Diagnostic Monitoring Software | 2006 | — |
| +2 | K062959 | DMS 300-2, 300-3 and 300-4 | Diagnostic Monitoring Software | 2006 | — |
| +1 | K031074 | Digital Ambulatory Ecg (Holter) Recorder | Datrix | 2003 | — |
| +3 | K133014 | DMS 300-2W Holter Ecg Recorder | Diagnostic Monitoring Software | 2014 | — |
| +2 | K112601 | Intricon Datrix Sirona Event/ Holter Recorder | Intricon Datrix Corporation | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
| 2011 | 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 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? (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…ame: Ambulatory ECG Recorder Classification Name: Recorder, Magnetic Tape, Medical 3. PREDICATE DEVICES Device 510(k) No. Date Cleared Datrix XR300 ECG Holter Recorder K921068 - March 30, 1992 Braemar DL700 Digital ECG Holter Recorder K945130 April 4, 1998 4. DESCRIPTION The DR512 is a lightweight, comp… | 1992 |
| * | K945130 | Braemar Model DL700 Ambulatory Electrocardiographic RecorderSummary page 1…c Tape, Medical 3. PREDICATE DEVICES Device 510(k) No. Date Cleared Datrix XR300 ECG Holter Recorder K921068 - March 30, 1992 Braemar DL700 Digital ECG Holter Recorder K945130 April 4, 1998 4. DESCRIPTION The DR512 is a lightweight, compact, digital Holter recorder designed for ambulatory ECG applicatio… | 1995 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All MWJ devicesMWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 DR512 digital Holter recorder is intended for the recording and storage of long-term ECG data collected from ambulatory patients. The recorder is used under the order of a physician, who reviews the data after downloading and processing by a Holter playback system. The physician determines the presence of normal and abnormal ECG data during the events of the patient’s daily activity.
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/K982975 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982975: Digital Ecg Holter Recorder, Model DR512.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982975
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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