510(k) · Cleared
ClearedCardiopal AI with Diogenes SV (Cardiopal SV), Model PM410
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicomp, Inc. · MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Cleared on Mar 24, 2005 as substantially equivalent to K981119 (Medicomp, Inc., 1998) after a 99-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it.
- Decided
- Mar 24, 2005
- Review
- 99 days
- Class
- Class II
- Product code
- MLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981119 (1998). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK981119 Cardiopal Model Number PM20Medicomp, Inc. · 1998
- This deviceK043454 Cardiopal AI with Diogenes SV (Cardiopal SV), Model PM410Medicomp, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK091696 Savi Wireless, Model PM500Medicomp, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK161916 TelePatch Cardiac MonitorMedicomp, Inc. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981119 | Cardiopal Model Number PM20 | Medicomp, Inc. | 1998 | — |
| 0 (this device) | K043454 | Cardiopal AI with Diogenes SV (Cardiopal SV), Model PM410 | Medicomp, Inc. | 2005 | — |
| +1 | K091696 | Savi Wireless, Model PM500 | Medicomp, Inc. | 2009 | — |
| +1 | K161916 | TelePatch Cardiac Monitor | Medicomp, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2016 | 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 MLO? 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 MLO device
- #1 K261580 ZBPro Diagnostic (Version 2.0)score 13.8 · 7 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 |
|---|---|---|---|
| * | K981119 | Cardiopal Model Number PM20 | 1998 |
What descends from it? (2)
2 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, K091696 (Medicomp, Inc., 2009) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MLO devicesMLO Electrocardiograph, Ambulatory, With Analysis Algorithm: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MLO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MLO
238in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MLO
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MLO
4in 2025
MAUDE reports naming product code MLO, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 3 | 238 | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 2 | 2 |
| 2025 | 1 | — | 0 | 4 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The CardioPAL Al with Diogenes SV (CardioPal SV) Model PM410, is a pager-sized, handheld or patient worn device designed specifically to record and transmit ambulatory ECG signals. The device can be worn for days or weeks, as it is intended for use by patients who are experiencing symptoms that are transient and infrequent in nature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043454 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043454: Cardiopal AI with Diogenes SV (Cardiopal SV), Model PM410.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043454
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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