510(k) · Cleared
ClearedCardiofax CE, Model Pea-1110K
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden America, Inc. · DPS Electrocardiograph
Cleared on Jan 6, 2005 after an 86-day review. The FDA summary names its predicate without a number.
- Decided
- Jan 6, 2005
- Review
- 86 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (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 |
|---|---|---|---|
| * | — | ECG-9130K Named without a submission number |
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.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Cardiofax CE electrocardiograph is intended for medical purposes to process the electrical signals transmitted through two or more electrocardiograph electrodes to produce a visual display and/or wireless transmission of data to a remote printer and/or computer. For non-interpretive applications, the device is intended for use with a full range of patient populations as determined by a clinician. The devices also provide an interpretive ECG program…
Read the full statement (129 words)
The Cardiofax CE electrocardiograph is intended for medical purposes to process the electrical signals transmitted through two or more electrocardiograph electrodes to produce a visual display and/or wireless transmission of data to a remote printer and/or computer. For non-interpretive applications, the device is intended for use with a full range of patient populations as determined by a clinician. The devices also provide an interpretive ECG program intended for use with patients age 3 years to adult.
The interpretation program is intended to provide an assessment of ECG waveform rhythm and morphology to assist the physician in diagnosis. Assessments provided by the interpretation program are not intended as the sole basis for diagnosis, All assessments provided by the interpretation program are recommended for review by qualified physicians trained In electrocardiography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042827 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042827: Cardiofax CE, Model Pea-1110K.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042827
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026