# K173952: Universal SmartECG

- Pathway: 510(k) (Traditional)
- Applicant: Vectracor, Inc.
- Decided: Aug 28, 2018 after 244 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: 14 generations back to K941811 (1994). 60 ancestors in all.
1 later device descends 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)
- K102378: Vectraplexecg System with Vectraplexami, Vectracor, Inc. (2011) Summary page 4.
- K990266: Micromedical 12 Lead Simultaneous Cable, Micromedical Industries, Ltd. (1999) Summary page 4.

## Most influential descendants
- K232035: Impala (2024), 0 descendants of its own

## Indications for use
The 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 and convert the ECG signal into a digital format. 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. In 5 electrode mode, the System 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 Ischemic Injury (AMII), including Acute Myocardial Infarction (AMI).This mode is not intended to be a sole means of diagnosis, but prompts the user to acquire a standard 12 lead ECG (using 10 electrodes) for interpretation by a physician when the Cardiac Electrical Biomarker (CEB®) is 95 or greater. Monitoring patients with a CEB® is only indicated for patients presenting with chest pain or other presumed anginal equivalents. The interpretation software is only available for the standard 12 lead ECG utilizing the standard 10 electrodes. The System is intended to be used by healthcare professionals, or trained personnel where ECG monitoring /acquisition is indicated for hospitals and/or clinics. The System can be used within electro-surgical environments. Device is for Adult use.

Source page: https://510kreport.com/device/K173952
Methodology: https://510kreport.com/methodology