510(k) · Cleared
ClearedE3-80 Portable Ecg Recorder & Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro-Star International Co., Ltd. · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on Oct 3, 2007 as substantially equivalent to K993617 (Braemar Corp., 1999) and 1 other predicate after a 169-day review. Its family tree reaches back 2 generations to 1996. 3 later devices descend from it.
- Decided
- Oct 3, 2007
- Review
- 169 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K950944 (1996). 3 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK950944 Ambulatory (Holter) Recording SystemBiosensor Corp. · 1996
- 1 generation backK993617 Digitrakplus Holter RecorderBraemar Corp. · 1999
- This deviceK071085 E3-80 Portable Ecg Recorder & AnalyzerMicro-Star International Co., Ltd. · 2007
- Descendant · cites it directly · 2 of its ownK101569 V-Trust Model TD-2202 Portable Ecg RecorderTaidoc Technology Corporation · 2011
- Descendant · 2 generations on · 0 of its ownK172221 VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs…Taidoc Technology Corporation · 2018
- Descendant · 2 generations on · 0 of its ownK131572 Micro Ambulatory Ecg RecorderDimetek Digital Medical Technologies, Ltd. · 2013
Most influential descendants
Showing 3 of 3 · See all- K101569V-Trust Model TD-2202 Portable Ecg RecorderTaidoc Technology Corporation · 2011 · cites it directly2descendants
- K172221VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100Taidoc Technology Corporation · 2018 · 2 generations on0descendants
- K131572Micro Ambulatory Ecg RecorderDimetek Digital Medical Technologies, Ltd. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950944 | Ambulatory (Holter) Recording System | Biosensor Corp. | 1996 | — |
| −1 | K993617 | Digitrakplus Holter Recorder | Braemar Corp. | 1999 | — |
| 0 (this device) | K071085 | E3-80 Portable Ecg Recorder & Analyzer | Micro-Star International Co., Ltd. | 2007 | — |
| +1 | K101569 | V-Trust Model TD-2202 Portable Ecg Recorder | Taidoc Technology Corporation | 2011 | — |
| +2 | K172221 | VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model… | Taidoc Technology Corporation | 2018 | — |
| +2 | K131572 | Micro Ambulatory Ecg Recorder | Dimetek Digital Medical Technologies, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K993617 | Digitrakplus Holter RecorderSummary page 1…alysis) 3. Predicate Device Trade Name 5100) Number Decision Date Braemar DigiTrak Plus Holter Recorder K993617 11/24/1999 Del Mar Lifecard CF Compact Holter Recorder K001025 04/19/2000 4. Device Descript… | 1999 |
| * | K001025 | Lifecard CF Compact RecorderSummary page 1…100) Number Decision Date Braemar DigiTrak Plus Holter Recorder K993617 11/24/1999 Del Mar Lifecard CF Compact Holter Recorder K001025 04/19/2000 4. Device Description The E3-80 ECG device is designed to be a portable recorder of electrocardiogram… | 2000 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101569 | V-Trust Model TD-2202 Portable Ecg Recorder | 2011 | 2 |
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 3 companies; a new generation was cleared every 7.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K101569 (Taidoc Technology Corporation, 2011) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K993617.
How does its category compare?
All MWJ devicesMWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 E3-80 is a 3-channel portable ECG device designed to record up to 24 hours of ECG signal from the chest surface of adult patients in an ambulatory environment.
The device stores ECG data to a removable storage disc for qualified healthcare providers to perform further analysis of recorded ECG.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071085 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071085: E3-80 Portable Ecg Recorder & Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071085
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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