510(k) · Cleared
ClearedARIA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Del Mar Medical Systems, LLC · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on Jul 21, 2000 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 25 later devices descend from it.
- Decided
- Jul 21, 2000
- Review
- 86 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 0
25 later devices descend from it, 1 citing it directly.
- This deviceK001317 ARIADel Mar Medical Systems, LLC · 2000
- Descendant · cites it directly · 24 of its ownK021470 Seer Light Compact Digital Holter RecorderGeneral Electric Medical Systems Information Techn · 2002
- Descendant · 2 generations on · 11 of its ownK073545 Audicor, Hemo Ambulatory MonitorInovise Medical, Inc. · 2008
- Descendant · 2 generations on · 10 of its ownK050731 Seer Light Extend Compact Digital Holter SystemGe Medical Systems Information Technologies · 2005
- Descendant · 3 generations on · 7 of its ownK112921 Medicalgorithmics Unified Arrhythmia Diagnostic SystemMedicalgorithmics S.A. · 2012
- Descendant · 3 generations on · 5 of its ownK124060 Medical Gorithmics Unified Arrhythmia Diagnostic SystemMedicalgorithmics S.A. · 2013
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K021470Seer Light Compact Digital Holter RecorderGeneral Electric Medical Systems Information Techn · 2002 · cites it directly24descendants
- K073545Audicor, Hemo Ambulatory MonitorInovise Medical, Inc. · 2008 · 2 generations on11descendants
- K050731Seer Light Extend Compact Digital Holter SystemGe Medical Systems Information Technologies · 2005 · 2 generations on10descendants
- K112921Medicalgorithmics Unified Arrhythmia Diagnostic SystemMedicalgorithmics S.A. · 2012 · 3 generations on7descendants
- K124060Medical Gorithmics Unified Arrhythmia Diagnostic SystemMedicalgorithmics S.A. · 2013 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001317 | ARIA | Del Mar Medical Systems, LLC | 2000 | — |
| +1 | K021470 | Seer Light Compact Digital Holter Recorder | General Electric Medical Systems Information Techn | 2002 | — |
| +2 | K073545 | Audicor, Hemo Ambulatory Monitor | Inovise Medical, Inc. | 2008 | — |
| +2 | K050731 | Seer Light Extend Compact Digital Holter System | Ge Medical Systems Information Technologies | 2005 | — |
| +3 | K112921 | Medicalgorithmics Unified Arrhythmia Diagnostic System | Medicalgorithmics S.A. | 2012 | — |
| +3 | K124060 | Medical Gorithmics Unified Arrhythmia Diagnostic System | Medicalgorithmics S.A. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (25)
See all 251 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021470 | Seer Light Compact Digital Holter Recorder | 2002 | 24 |
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?
- Of its descendants, K021470 (General Electric Medical Systems Information Techn, 2002) has gone furthest, with 24 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 | — |
https://510kreport.com/device/K001317 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001317: ARIA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001317
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026