510(k) · Cleared
ClearedKenz CARDY302 Max
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzuken Co., Ltd. · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on Jan 6, 2011 as substantially equivalent to K050731 (Ge Medical Systems Information Technologies, 2005) after a 268-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Jan 6, 2011
- Review
- 268 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001317 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK001317 ARIADel Mar Medical Systems, LLC · 2000
- 2 generations backK021470 Seer Light Compact Digital Holter RecorderGeneral Electric Medical Systems Information Techn · 2002
- 1 generation backK050731 Seer Light Extend Compact Digital Holter SystemGe Medical Systems Information Technologies · 2005
- This deviceK101024 Kenz CARDY302 MaxSuzuken Co., Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001317 | ARIA | Del Mar Medical Systems, LLC | 2000 | — |
| −2 | K021470 | Seer Light Compact Digital Holter Recorder | General Electric Medical Systems Information Techn | 2002 | — |
| −1 | K050731 | Seer Light Extend Compact Digital Holter System | Ge Medical Systems Information Technologies | 2005 | — |
| 0 (this device) | K101024 | Kenz CARDY302 Max | Suzuken Co., Ltd. | 2011 | — |
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 |
|---|---|---|---|
| * | K050731 | Seer Light Extend Compact Digital Holter SystemSummary page 1…r Classification Electrocardiograph, Ambulatory (without analysis) Name: Medical Magnetic Tape Recorder Predicate Device: SEER Light Extend (K05073 1) Device Description: The Cardy3o2Max Compact Digital Hotter System is designed to acquire ambulatory 2 o… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 4 companies; a new generation was cleared every 2.5 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K050731.
How does its category compare?
All MWJ devicesMWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Cardy302Max Compact Digital Holter Recorder System is intended to acquire ambulatory 2 or 3 channel ECG signals from the chest surface of pediatric or adult patients. The device stored this data along with patient demographic information onto a removable SD memory card. The Cardy302Max Compact Digital Holter Recorder System is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or…
Read the full statement (109 words)
The Cardy302Max Compact Digital Holter Recorder System is intended to acquire ambulatory 2 or 3 channel ECG signals from the chest surface of pediatric or adult patients. The device stored this data along with patient demographic information onto a removable SD memory card.
The Cardy302Max Compact Digital Holter Recorder 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 Cardy302Max Compact Digital Holter Recorder System does not perform any analysis of the ECG data.
The Cardy302Max Compact Digital Holter Recorder System is not intended for use on patients weighing less than 10 kg.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101024 · printed Nov 3, 2026
Cite this page
510(k) Report. “K101024: Kenz CARDY302 Max.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101024
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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