510(k) · Cleared
ClearedSeer Light Extend Compact Digital Holter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on May 19, 2005 as substantially equivalent to K021470 (General Electric Medical Systems Information Techn, 2002) after a 59-day review. Its family tree reaches back 2 generations to 2000. 10 later devices descend from it.
- Decided
- May 19, 2005
- Review
- 59 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001317 (2000). 10 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK001317 ARIADel Mar Medical Systems, LLC · 2000
- 1 generation backK021470 Seer Light Compact Digital Holter RecorderGeneral Electric Medical Systems Information Techn · 2002
- This deviceK050731 Seer Light Extend Compact Digital Holter SystemGe Medical Systems Information Technologies · 2005
- Descendant · cites it directly · 7 of its ownK112921 Medicalgorithmics Unified Arrhythmia Diagnostic SystemMedicalgorithmics S.A. · 2012
- Descendant · cites it directly · 5 of its ownK124060 Medical Gorithmics Unified Arrhythmia Diagnostic SystemMedicalgorithmics S.A. · 2013
- Descendant · 2 generations on · 3 of its ownK152550 Medicalgorithmics Unified Arrhythmia Diagnosic SystemMedicalgorithmics S.A. · 2015
- Descendant · 3 generations on · 1 of its ownK200833 RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc. · 2020
- Descendant · 4 generations on · 0 of its ownK241179 Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)VivaQuant, Inc. · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K112921Medicalgorithmics Unified Arrhythmia Diagnostic SystemMedicalgorithmics S.A. · 2012 · cites it directly7descendants
- K124060Medical Gorithmics Unified Arrhythmia Diagnostic SystemMedicalgorithmics S.A. · 2013 · cites it directly5descendants
- K152550Medicalgorithmics Unified Arrhythmia Diagnosic SystemMedicalgorithmics S.A. · 2015 · 2 generations on3descendants
- K200833RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc. · 2020 · 3 generations on1descendant
- K241179Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)VivaQuant, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001317 | ARIA | Del Mar Medical Systems, LLC | 2000 | — |
| −1 | K021470 | Seer Light Compact Digital Holter Recorder | General Electric Medical Systems Information Techn | 2002 | — |
| 0 (this device) | K050731 | Seer Light Extend Compact Digital Holter System | Ge Medical Systems Information Technologies | 2005 | — |
| +1 | K112921 | Medicalgorithmics Unified Arrhythmia Diagnostic System | Medicalgorithmics S.A. | 2012 | — |
| +1 | K124060 | Medical Gorithmics Unified Arrhythmia Diagnostic System | Medicalgorithmics S.A. | 2013 | — |
| +2 | K152550 | Medicalgorithmics Unified Arrhythmia Diagnosic System | Medicalgorithmics S.A. | 2015 | — |
| +3 | K200833 | RX-1 Rhythm Express Remote Cardiac Monitoring System | VivaQuant, Inc. | 2020 | — |
| +4 | K241179 | Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) | VivaQuant, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K021470 | Seer Light Compact Digital Holter RecorderSummary page 1…sis) Medical Magnetic Tape Recorder Predicate Device: SEER Light Compact Digital Holter Recorder and Controller (K02 1470) Device Description: The SEER Light Extend Compact Digital Hotter Recorder is designed to… | 2002 |
What descends from it? (10)
4 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?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K112921 (Medicalgorithmics S.A., 2012) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K021470.
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 SEER Light Extend Compact Digital Holter Recorder and Controller System is intended to acquire ambulatory 2 or 3 channel ECG signals from the chest surface of pediatric and adult patients. The device stores this data along with patient demographic information to on board flash memory. The SEER Light Extend Compact Digital Holter System is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a…
Read the full statement (114 words)
The SEER Light Extend Compact Digital Holter Recorder and Controller System is intended to
acquire ambulatory 2 or 3 channel ECG signals from the chest surface of pediatric and adult patients.
The device stores this data along with patient demographic information to on board flash memory.
The SEER Light Extend Compact Digital Holter System is intended to be used by trained operators
under the direct supervision of a licensed healthcare practitioner in a hospital or medical professional's
facility.
The SEER Light Extend Compact Digital Holter System does not perform any analysis of the ECG
data.
The SEER Light Extend Compact Digital Holter System is not intended for use on patients weighing
less than 10Kg.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050731 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050731: Seer Light Extend Compact Digital Holter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050731
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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