510(k) · Cleared
ClearedVectraplexecg System with Vectraplexami
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vectracor, Inc. · DPS Electrocardiograph
Cleared on Nov 2, 2011 as substantially equivalent to K990266 (Micromedical Industries, Ltd., 1999) and 2 other predicates after a 439-day review. Its family tree reaches back 13 generations to 1994. 2 later devices descend from it.
- Decided
- Nov 2, 2011
- Review
- 439 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K941811 (1994). 59 ancestors in all, the oldest K872781 (1987). 2 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 9 generations between
- 3 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 2 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 1 generation backK033513 Easi Ecg AlgorithmPhilips Medical Systems · 2004
- This deviceK102378 Vectraplexecg System with VectraplexamiVectracor, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK173952 Universal SmartECGVectracor, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK232035 ImpalaAliveCor, Inc. · 2024
Show all 13 generations
- Root · 13 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 12 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 11 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 10 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 9 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 8 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 7 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 6 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 5 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 4 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 3 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 2 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 1 generation backK033513 Easi Ecg AlgorithmPhilips Medical Systems · 2004
- This deviceK102378 Vectraplexecg System with VectraplexamiVectracor, Inc. · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −12 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −11 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −10 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −9 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −8 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −7 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −6 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −5 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −4 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −3 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −2 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −1 | K033513 | Easi Ecg Algorithm | Philips Medical Systems | 2004 | — |
| 0 (this device) | K102378 | Vectraplexecg System with Vectraplexami | Vectracor, Inc. | 2011 | — |
| +1 | K173952 | Universal SmartECG | Vectracor, Inc. | 2018 | — |
| +2 | K232035 | Impala | AliveCor, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 7 | 0 |
| 2000 | 10 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2024 | 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? (3)
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 |
|---|---|---|---|
| * | K990266 | Micromedical 12 Lead Simultaneous CableSummary page 2…are LOS Document U: V0004 rev 1.3 3. Predicate Device Identification: o Micromedical - 12 lead simultaneous Cable - 510OK K990266. o Primary Care Physicain Platform ILLC, dba QRS Diagnostic, LLC. Gardioview/ Office Medic - 510K # K083… | 1999 |
| * | K083749 | CARDIOVIEW32 Review ModuleSummary page 2…- 12 lead simultaneous Cable - 510OK K990266. o Primary Care Physicain Platform ILLC, dba QRS Diagnostic, LLC. Gardioview/ Office Medic - 510K # K083749 - This is the interpretive software- received 510K clearance -Feb/Mar 2009. Previous 510k cleared was K9743… | 2009 |
| * | K033513 | Easi Ecg AlgorithmSummary page 2…clearance -Feb/Mar 2009. Previous 510k cleared was K974352 (Cardioview EGG Interpretative Software) o Philips EASI EGG Algorithm - 510OK K033513 4. Device Description The VectraplexECG System will be able to display and print a 12 lead EGG with 10 electrodes att… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173952 | Universal SmartECG | 2018 | 1 |
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 17 years and passes through 6 companies; a new generation was cleared every 4 months on median.
- 3 of the 59 ancestors have a recall of any class.
- Of its descendants, K173952 (Vectracor, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K990266.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
VectraCor's VectraplexECG System with VectraplexAMI analyzes data from 3 leads (5 electrodes) and produces visual and audible alarms for ECG changes that may be consistent with 12-lead ECG signs of acute myocardial infarction. The device does not provide a diagnosis of acute myocardial infarction, but prompts the user to acquire a standard 12 lead ECG (using 10 electrodes) for interpretation by a physician. Monitoring patients with VectraplexAMI is only…
Read the full statement (252 words)
VectraCor's VectraplexECG System with VectraplexAMI analyzes data from 3 leads (5 electrodes) and produces visual and audible alarms for ECG changes that may be consistent with 12-lead ECG signs of acute myocardial infarction. The device does not provide a diagnosis of acute myocardial infarction, but prompts the user to acquire a standard 12 lead ECG (using 10 electrodes) for interpretation by a physician. Monitoring patients with VectraplexAMI is only indicated for patients presenting with chest pain or other presumed anginal equivalents.
* The VectraplexECG System is intended to derive, display and print a derived 12 lead ECG as well as the X, Y, Z leads from the acquisition of just 3 leads (5 electrodes). The System also has the capability to acquire the standard 12 lead ECG using the standard 10 electrodes. The interpretation software is only available for the standard 12 lead ECG utilizing the standard 10 electrodes.
* VectraplexECG is intended to be used by healthcare professionals, i.e. Physicians, Nurses, Technicians, and Physician Assistants, where 12 lead and X, Y, Z leads are indicated for Hospitals and/or Clinics.
* The 12 lead interpretive software is a windows-based program intended to interpret electrocardiograms. The software receives, displays and stores a single, three or standard 12 lead simultaneous ECG recording, which is transmitted either locally or transtelephonically from an ECG monitor using a proprietary digital data transmission protocol. The device contains proprietary software algorithms to receive, store, analyze and interpret the 12 lead ECG signal only.
* Device is for Adult use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102378 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102378: Vectraplexecg System with Vectraplexami.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102378
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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