510(k) · Cleared
ClearedER800 Series Ecg Event Recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Braemar Corp. · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on Mar 28, 2003 as substantially equivalent to K981394 (Braemar Corp., 1998) and 2 other predicates after a 10-day review. Its family tree reaches back 2 generations to 1992. 6 later devices descend from it.
- Decided
- Mar 28, 2003
- Review
- 10 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K923930 (1992). 4 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK923930 Electrocardiograph TransmitterTz Medical, Inc. · 1992
- 1 generation backK981394 Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720Braemar Corp. · 1998
- This deviceK030856 ER800 Series Ecg Event RecorderBraemar Corp. · 2003
- Descendant · cites it directly · 5 of its ownK061293 Telaheart Digital RecorderNorth East Monitoring, Inc. · 2006
- Descendant · 2 generations on · 3 of its ownK142424 DR300 Holter MonitorNorth East Monitoring, Inc. · 2014
- Descendant · 3 generations on · 2 of its ownK151787 Holter SystemEdan Instruments, Inc. · 2016
- Descendant · 4 generations on · 0 of its ownK254119 Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder…Shenzhen Xinyan Medical Technology Co.,ltd. · 2026
- Descendant · 4 generations on · 0 of its ownK251591 Holter ECG and ABP system (HolterABP)Edan Instruments, Inc. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K061293Telaheart Digital RecorderNorth East Monitoring, Inc. · 2006 · cites it directly5descendants
- K142424DR300 Holter MonitorNorth East Monitoring, Inc. · 2014 · 2 generations on3descendants
- K151787Holter SystemEdan Instruments, Inc. · 2016 · 3 generations on2descendants
- K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…Shenzhen Xinyan Medical Technology Co.,ltd. · 2026 · 4 generations on0descendants
- K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923930 | Electrocardiograph Transmitter | Tz Medical, Inc. | 1992 | — |
| −1 | K981394 | Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720 | Braemar Corp. | 1998 | — |
| 0 (this device) | K030856 | ER800 Series Ecg Event Recorder | Braemar Corp. | 2003 | — |
| +1 | K061293 | Telaheart Digital Recorder | North East Monitoring, Inc. | 2006 | — |
| +2 | K142424 | DR300 Holter Monitor | North East Monitoring, Inc. | 2014 | — |
| +3 | K151787 | Holter System | Edan Instruments, Inc. | 2016 | — |
| +4 | K254119 | Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart… | Shenzhen Xinyan Medical Technology Co.,ltd. | 2026 | — |
| +4 | K251591 | Holter ECG and ABP system (HolterABP) | Edan Instruments, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2026 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K981394 | Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720Summary page 1SECTION 3. 5 10(k) SUMMARY 0 Substantially Equivalent (SE) To: Braemar Model ER700 Ambulatory Devices 5 1O(k) K98 1394 Biosensor Model 1005 5 1O(k) K950944… | 1998 |
| * | K950944 | Ambulatory (Holter) Recording SystemSummary page 1…ory Devices 5 1O(k) K98 1394 Biosensor Model 1005 5 1O(k) K950944 Braemar Model DXP 1000 510(k) K993618 M… | 1996 |
| * | K993618 | DXP1000 Holter RecorderSummary page 1…5 1O(k) K950944 Braemar Model DXP 1000 510(k) K993618 Modification Background The essence of this modification is a change to the recorder hardware to a smaller configuration with re… | 1999 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061293 | Telaheart Digital Recorder | 2006 | 5 |
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 11 years and passes through 2 companies; a new generation was cleared every 5.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K061293 (North East Monitoring, Inc., 2006) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K981394.
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?
To record infrequent and elusive ECG heart arrhythmia data. Once data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review. The electrocardiogram (ECG) is a graphic description of the electrical activity of the heart. This activity is recorded form the body surface by a group of electrodes positioned at predefined places to reflect the activity from different perspectives. Depending on how these…
Read the full statement (119 words)
To record infrequent and elusive ECG heart arrhythmia data. Once data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review.
The electrocardiogram (ECG) is a graphic description of the electrical activity of the heart. This activity is recorded form the body surface by a group of electrodes positioned at predefined places to reflect the activity from different perspectives. Depending on how these electrodes are placed, the ECG waveforms are considered as separate linearly dependent signals. Presently the ECG is the most prominent and widely used non-invasive cardiac diagnostic technique. There exists a significant accumulation of correlated clinical data, which provides a powerhl basis for evaluation of these biophysical signals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030856 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030856: ER800 Series Ecg Event Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030856
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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