510(k) · Cleared
ClearedCardio-TriTest
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardio-Phoenix, Inc. · DPS Electrocardiograph
Cleared on Jun 3, 2015 as substantially equivalent to K081603 (Heartforce Medical, Inc., 2009) and 1 other predicate after a 184-day review. Its family tree reaches back 5 generations to 1994. 1 later device descends from it.
- Decided
- Jun 3, 2015
- Review
- 184 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K930806 (1994). 11 ancestors in all, the oldest K910994 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK930806 Zymed Holter Scanner Model 2010Agilent Technologies · 1994
- 4 generations backK955015 Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 1996
- 3 generations backK990170 Holter 2000Zymed Medical Instrumentation · 1999
- 2 generations backK010949 2010 Plus Holter for WindowsAgilent Technologies · 2001
- 1 generation backK031517 Zargis Acoustic CardioscanZargis Medical Corp. · 2004
- This deviceK143432 Cardio-TriTestCardio-Phoenix, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK182790 Cardio-TriTest v6.5Cardio-Phoenix, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K182790Cardio-TriTest v6.5Cardio-Phoenix, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K930806 | Zymed Holter Scanner Model 2010 | Agilent Technologies | 1994 | — |
| −4 | K955015 | Zymed Holter Scanner Model 2010 | Zymed Medical Instrumentation | 1996 | — |
| −3 | K990170 | Holter 2000 | Zymed Medical Instrumentation | 1999 | — |
| −2 | K010949 | 2010 Plus Holter for Windows | Agilent Technologies | 2001 | — |
| −1 | K031517 | Zargis Acoustic Cardioscan | Zargis Medical Corp. | 2004 | — |
| 0 (this device) | K143432 | Cardio-TriTest | Cardio-Phoenix, Inc. | 2015 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (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 |
|---|---|---|---|
| * | K081603 | Digital Ballistocardiograph, Model DGB 300Summary page 5…K143432 510(k) Summary Legally marketed predicate devices: DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 (K081603) Zargis Acoustic Cardioscan-ZAC (K031517) Reference device: 3M Littmann Electronic Stethoscope, Model 4000 (K0037… | 2009 |
| * | K031517 | Zargis Acoustic CardioscanSummary page 5…510(k) Summary Legally marketed predicate devices: DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 (K081603) Zargis Acoustic Cardioscan-ZAC (K031517) Reference device: 3M Littmann Electronic Stethoscope, Model 4000 (K003723) Device Description The Cardio-TriTest is… | 2004 |
| † | K003723 | 3M Littmann | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182790 | Cardio-TriTest v6.5 | 2018 | 0 |
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 21 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K182790 (Cardio-Phoenix, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K081603.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 this device is to acquire and record 3 different types of heart bio-signals (ECG, PCG, 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. Not intended for use in pediatrics. Not…
Read the full statement (140 words)
The intended use of this device is to acquire and record 3 different types of heart bio-signals (ECG, PCG, 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.
Not intended for use in pediatrics.
Not intended for patients in the intensive care units.
Intended population:
Males and females greater than or equal to 20 years of age.
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/K143432 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143432: Cardio-TriTest.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143432
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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