# K102378: Vectraplexecg System with Vectraplexami

- Pathway: 510(k) (Traditional)
- Applicant: Vectracor, Inc.
- Decided: Nov 2, 2011 after 439 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K941811 (1994). 59 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990266: Micromedical 12 Lead Simultaneous Cable, Micromedical Industries, Ltd. (1999) Summary page 2.
- K083749: CARDIOVIEW32 Review Module, Qrs Diagnostic, LLC (2009) Summary page 2.
- K033513: Easi Ecg Algorithm, Philips Medical Systems (2004) Summary page 2.

## Most influential descendants
- K173952: Universal SmartECG (2018), 1 descendant of its own
- K232035: Impala (2024), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K102378
Methodology: https://510kreport.com/methodology