510(k) · Cleared
ClearedCARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trismed Co., Ltd. · DPS Electrocardiograph
Cleared on Nov 21, 2023 as substantially equivalent to K133622 (Wipro GE Healthcare, 2014) after a 239-day review. Its family tree reaches back 8 generations to 1993.
- Decided
- Nov 21, 2023
- Review
- 239 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K921669 (1993). 22 ancestors in all, the oldest K820885 (1982). No later device cites it as a predicate yet.
- Root · 8 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 7 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 6 generations backK991735 Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6…General Electric Medical Systems Information Techn · 1999
- 5 generations backK014108 Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn · 2002
- 4 generations backK033492 Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2003
- 3 generations backK042177 Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2004
- 2 generations backK073625 Modification to: Mac 5500 Resting Ecg Analysis SystemGe Healthcare Systems Information Technologies · 2008
- 1 generation backK133622 Mac 2000 Ecg Analysis SystemWipro GE Healthcare · 2014
- This deviceK230834 CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800HTrismed Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −7 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −6 | K991735 | Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac… | General Electric Medical Systems Information Techn | 1999 | — |
| −5 | K014108 | Mac 5000 Ecg Analysis System | General Electric Medical Systems Information Techn | 2002 | — |
| −4 | K033492 | Modification to Mac 5000 Ecg Analysis System | Ge Medical Systems Information Technologies | 2003 | — |
| −3 | K042177 | Modification to Mac 5000 Ecg Analysis System | Ge Medical Systems Information Technologies | 2004 | — |
| −2 | K073625 | Modification to: Mac 5500 Resting Ecg Analysis System | Ge Healthcare Systems Information Technologies | 2008 | — |
| −1 | K133622 | Mac 2000 Ecg Analysis System | Wipro GE Healthcare | 2014 | — |
| 0 (this device) | K230834 | CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H | Trismed Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 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 |
|---|---|---|---|
| * | K133622 | Mac 2000 Ecg Analysis SystemSummary page 5…fication, is substantially equivalent to the following commercially available electrocardiograph device: Predicate device (Legally Marketed Device) • K133622 – MAC2000 ECG Analysis System, WIPRO GE Healthcare IV. DEVICE DESCRIPTION The CARDIPIA800H and CARDIPIA400H consist of m… | 2014 |
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 30 years and passes through 6 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 22 ancestors has a recall of any class.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
CARDIPIA800H and CARDIPIA400H are the portable recording device which is to acquire, display, record, and export 12-lead ECG signals and data defined as the electrical heart activity induced on patient skin. ECG are intended to use for adult and pediatric which is defined between 0 and 15 years old by a physician, trained or licensed professionals in a hospital, clinic, medical office, medical use facilities or a prescribed environment under the…
Read the full statement (112 words)
CARDIPIA800H and CARDIPIA400H are the portable recording device which is to acquire, display, record, and export 12-lead ECG signals and data defined as the electrical heart activity induced on patient skin. ECG are intended to use for adult and pediatric which is defined between 0 and 15 years old by a physician, trained or licensed professionals in a hospital, clinic, medical office, medical use facilities or a prescribed environment under the direction of a physician.
CARDIPIA800H and CARDIPIA400H have the resting ECG,12/6-recording and displaying, 12-lead ECG measurement, and optional export ECG data for hospital information system.
NOTE: ECG should not be used as the patient monitoring system for long term patient monitor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230834 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230834: CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230834
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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