510(k) · Cleared
ClearedSeer Light Compact Digital Holter Recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Medical Systems Information Techn · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on Nov 14, 2002 as substantially equivalent to K001317 (Del Mar Medical Systems, LLC, 2000) after a 190-day review. Its family tree reaches back 1 generation to 2000. 24 later devices descend from it.
- Decided
- Nov 14, 2002
- Review
- 190 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001317 (2000). 24 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK001317 ARIADel Mar Medical Systems, LLC · 2000
- This deviceK021470 Seer Light Compact Digital Holter RecorderGeneral Electric Medical Systems Information Techn · 2002
- Descendant · cites it directly · 11 of its ownK073545 Audicor, Hemo Ambulatory MonitorInovise Medical, Inc. · 2008
- Descendant · cites it directly · 10 of its ownK050731 Seer Light Extend Compact Digital Holter SystemGe Medical Systems Information Technologies · 2005
- Descendant · 2 generations on · 7 of its ownK112921 Medicalgorithmics Unified Arrhythmia Diagnostic SystemMedicalgorithmics S.A. · 2012
- Descendant · 2 generations on · 5 of its ownK124060 Medical Gorithmics Unified Arrhythmia Diagnostic SystemMedicalgorithmics S.A. · 2013
- Descendant · 2 generations on · 4 of its ownK192004 Eko Analysis SoftwareEko Devices, Inc. · 2020
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K073545Audicor, Hemo Ambulatory MonitorInovise Medical, Inc. · 2008 · cites it directly11descendants
- K050731Seer Light Extend Compact Digital Holter SystemGe Medical Systems Information Technologies · 2005 · cites it directly10descendants
- K112921Medicalgorithmics Unified Arrhythmia Diagnostic SystemMedicalgorithmics S.A. · 2012 · 2 generations on7descendants
- K124060Medical Gorithmics Unified Arrhythmia Diagnostic SystemMedicalgorithmics S.A. · 2013 · 2 generations on5descendants
- K192004Eko Analysis SoftwareEko Devices, Inc. · 2020 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001317 | ARIA | Del Mar Medical Systems, LLC | 2000 | — |
| 0 (this device) | K021470 | Seer Light Compact Digital Holter Recorder | General Electric Medical Systems Information Techn | 2002 | — |
| +1 | K073545 | Audicor, Hemo Ambulatory Monitor | Inovise Medical, Inc. | 2008 | — |
| +1 | K050731 | Seer Light Extend Compact Digital Holter System | Ge Medical Systems Information Technologies | 2005 | — |
| +2 | K112921 | Medicalgorithmics Unified Arrhythmia Diagnostic System | Medicalgorithmics S.A. | 2012 | — |
| +2 | K124060 | Medical Gorithmics Unified Arrhythmia Diagnostic System | Medicalgorithmics S.A. | 2013 | — |
| +2 | K192004 | Eko Analysis Software | Eko Devices, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 3 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K001317 | ARIA | 2000 |
What descends from it? (24)
See all 243 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?
- Its one ancestor has no recall.
- Of its descendants, K073545 (Inovise Medical, Inc., 2008) has gone furthest, with 11 descendants of its own.
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 intended use of the SEER Light Compact Digital Holter Recorder is to acquire ambulatory 2 or 3 channels of ECG signal from the chest surface of pediatric or adult patients for no longer than 24 hours. The device stores this data along with patient demographic information to on board flash memory. It does not perform any analysis on the ECG data.
The SEER Light Compact Digtal Holter Recorder is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021470 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021470: Seer Light Compact Digital Holter Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021470
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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