510(k) · Cleared
ClearedSingle-Channel Handheld Electrocardiograph, Model ECG80A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Contec Medical System Co., Ltd. · DPS Electrocardiograph
Cleared on Aug 25, 2009 as substantially equivalent to K082124 (Et Medical Devices Spa, 2009) and 1 other predicate after a 145-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Aug 25, 2009
- Review
- 145 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K002074 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK002074 AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View HesH&C Medical Devices Spa · 2000
- 2 generations backK051534 Cardioline AR 600, AR 1200, AR 2100Et Medical Devices Spa · 2005
- 1 generation backK082124 Carditte MicrotelEt Medical Devices Spa · 2009
- This deviceK090936 Single-Channel Handheld Electrocardiograph, Model ECG80AContec Medical System Co., Ltd. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002074 | AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View Hes | H&C Medical Devices Spa | 2000 | — |
| −2 | K051534 | Cardioline AR 600, AR 1200, AR 2100 | Et Medical Devices Spa | 2005 | — |
| −1 | K082124 | Carditte Microtel | Et Medical Devices Spa | 2009 | — |
| 0 (this device) | K090936 | Single-Channel Handheld Electrocardiograph, Model ECG80A | Contec Medical System Co., Ltd. | 2009 | — |
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 DPS? 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 DPS device
- #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K082124 | Carditte MicrotelSummary page 1…1 CFR 870.2340 Device Class: Class II Submission Purpose: New Device Predicate Device: Cardiette microtel K082124 Manufactured by: Et medical devices spa Via De Zinis 6, 38011 Cav… | 2009 |
| * | K051534 | Cardioline AR 600, AR 1200, AR 2100Summary page 1…ices spa Via De Zinis 6, 38011 Cavareno (Trento) ITALY CARDIOLINE AR1200 K051534 Manufactured by: Et medical devices spa Via De Zinis 6,… | 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 9 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K082124.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, 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 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
What is it indicated for?
The ECG80A Single-Channel Handheld Electrocardiograph is intended for use in non-invasive recording and displaying ECG waveform of adult patients. In addition, it also can provide to the treating physician with relevant data on the cardiac rhythm in hospital patients. It is immediately available at any time to manually record transient cardiac events, suitable for patient and professional use, helpful in determining the cardiac rhythm at the time of symptoms. This device allows the patient to record their ECG data for displaying or print on the paper.
The product is not a conventional diagnostic tool.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090936 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090936: Single-Channel Handheld Electrocardiograph, Model ECG80A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090936
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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