510(k) · Cleared
ClearedCardio-TriTest v6.5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardio-Phoenix, Inc. · DPS Electrocardiograph
Cleared on Dec 14, 2018 as substantially equivalent to K143432 (Cardio-Phoenix, Inc., 2015) after a 74-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Dec 14, 2018
- Review
- 74 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K930806 (1994). 12 ancestors in all, the oldest K910994 (1992). No later device cites it as a predicate yet.
- Root · 6 generations backK930806 Zymed Holter Scanner Model 2010Agilent Technologies · 1994
- 5 generations backK955015 Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 1996
- 4 generations backK990170 Holter 2000Zymed Medical Instrumentation · 1999
- 3 generations backK010949 2010 Plus Holter for WindowsAgilent Technologies · 2001
- 2 generations backK031517 Zargis Acoustic CardioscanZargis Medical Corp. · 2004
- 1 generation backK143432 Cardio-TriTestCardio-Phoenix, Inc. · 2015
- This deviceK182790 Cardio-TriTest v6.5Cardio-Phoenix, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930806 | Zymed Holter Scanner Model 2010 | Agilent Technologies | 1994 | — |
| −5 | K955015 | Zymed Holter Scanner Model 2010 | Zymed Medical Instrumentation | 1996 | — |
| −4 | K990170 | Holter 2000 | Zymed Medical Instrumentation | 1999 | — |
| −3 | K010949 | 2010 Plus Holter for Windows | Agilent Technologies | 2001 | — |
| −2 | K031517 | Zargis Acoustic Cardioscan | Zargis Medical Corp. | 2004 | — |
| −1 | K143432 | Cardio-TriTest | Cardio-Phoenix, Inc. | 2015 | — |
| 0 (this device) | K182790 | Cardio-TriTest v6.5 | Cardio-Phoenix, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K143432 | Cardio-TriTestSummary page 6…= K182790 510(k) Summary – Cardio-TriTest v6.5 Legally marketed predicate devices: Cardio-TriTest v5.5 (k143432) Device Description The Cardio-TriTest v6.5 (CTT) is three devices in one; combining a 12-Lead Electrocardiograph (ECG), a 4 Le… | 2015 |
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 24 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- None of the 12 ancestors has a recall.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 intended use of the device is to acquire and record the 3 different types of heart bio-signals (ECG, PCG, and MCG) and combine the results into a contiguous presentation as an aid to diagnostic interpretation by a Physician in a clinical setting.
The indication for use is as...
a. a Standard 12 Lead Diagnostic ECG
b. an aid to identify events in the cardiac cycle
c. an aid to detect S1 & S2 hearts sounds and murmurs.
Any diagnostic interpretation is only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data.
The Cardio-TriTest is on a prescription basis by a Certified Medical Practitioner.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182790 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182790: Cardio-TriTest v6.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182790
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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