510(k) · Cleared
ClearedKardioScreen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imedrix Inc. (Formerly Piitech Inc.) · DPS Electrocardiograph
Cleared on Jan 10, 2020 as substantially equivalent to K161302 (Edan Instruments, Inc., 2016) after a 199-day review. Its family tree reaches back 10 generations to 1991.
- Decided
- Jan 10, 2020
- Review
- 199 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K903644 (1991). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK903644 Series 1500 12-Lead Analysis OptionMarquette Electronics, Inc. · 1991
- 6 generations between
- 3 generations backK131819 PC ECGEdan Instruments, Inc. · 2013
- 2 generations backK152427 PC ECGEdan Instruments, Inc. · 2016
- 1 generation backK161302 PC ECGEdan Instruments, Inc. · 2016
- This deviceK191692 KardioScreenImedrix Inc. (Formerly Piitech Inc.) · 2020
Show all 10 generations
- Root · 10 generations backK903644 Series 1500 12-Lead Analysis OptionMarquette Electronics, Inc. · 1991
- 9 generations backK973403 Cardiosmart STMarquette Medical Systems, Inc. · 1998
- 8 generations backK991014 Case 8000 Exercise Testing SystemGeneral Electric Medical Systems Information Techn · 1999
- 7 generations backK023380 T-Wave Altermans (Twa) Algorithm OptionGeneral Electric Medical Systems Information Techn · 2002
- 6 generations backK031561 Cardiosoft/Case Cardiac Testing SystemGe Medical Systems Information Technologies · 2003
- 5 generations backK092010 PC Ecg, Model SE-1010Edan Instruments, Inc. · 2009
- 4 generations backK102854 PC ECGEdan Instruments, Inc. · 2010
- 3 generations backK131819 PC ECGEdan Instruments, Inc. · 2013
- 2 generations backK152427 PC ECGEdan Instruments, Inc. · 2016
- 1 generation backK161302 PC ECGEdan Instruments, Inc. · 2016
- This deviceK191692 KardioScreenImedrix Inc. (Formerly Piitech Inc.) · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K903644 | Series 1500 12-Lead Analysis Option | Marquette Electronics, Inc. | 1991 | — |
| −9 | K973403 | Cardiosmart ST | Marquette Medical Systems, Inc. | 1998 | — |
| −8 | K991014 | Case 8000 Exercise Testing System | General Electric Medical Systems Information Techn | 1999 | — |
| −7 | K023380 | T-Wave Altermans (Twa) Algorithm Option | General Electric Medical Systems Information Techn | 2002 | — |
| −6 | K031561 | Cardiosoft/Case Cardiac Testing System | Ge Medical Systems Information Technologies | 2003 | — |
| −5 | K092010 | PC Ecg, Model SE-1010 | Edan Instruments, Inc. | 2009 | — |
| −4 | K102854 | PC ECG | Edan Instruments, Inc. | 2010 | — |
| −3 | K131819 | PC ECG | Edan Instruments, Inc. | 2013 | — |
| −2 | K152427 | PC ECG | Edan Instruments, Inc. | 2016 | — |
| −1 | K161302 | PC ECG | Edan Instruments, Inc. | 2016 | — |
| 0 (this device) | K191692 | KardioScreen | Imedrix Inc. (Formerly Piitech Inc.) | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K161302 | PC ECGSummary page 4…on: 21 CFR 870.2340 Regulatory Class: II III. PREDICATE DEVICE The primary predicate device is Edan Instruments, Inc.’s PADECG, which was cleared under K161302. This predicate device has not been to subject of a recall. IV. DEVICE DESCRIPTION KardioScreen is a portable battery-operated… | 2016 |
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 29 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- None of the 16 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. 2020, 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?
KardioScreen is a portable and mobile device intended to acquire a resting, diagnostic ECG using surface electrodes from adult patients and pediatric patients age 14-21 years. The device is intended to be used by doctors and/or trained healthcare professionals in a hospital, medical professional's facility, clinic, physician's office or any medical outreach center. The device can acquire, display, analyze and print either 6-lead or 12-lead electrocardiograms which can be exported for external use. The recorded ECG signals can help users to analyze and diagnose heart disease, but the device is not meant as a sole means of diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191692 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191692: KardioScreen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191692
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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