# K081473: Hero, Version 2.0

- Pathway: 510(k) (Special)
- Applicant: Medical Predictive Science Corp.
- Decided: Jun 27, 2008 after 31 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: 3 generations back to K922171 (1992). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021230: HERO, Medical Decision Networks (2003) Summary page 1.

## Most influential descendants
- K111601: HERO (2011), 1 descendant of its own
- K180242: HeRO Symphony, HeRO ES, HeRO solo/duet (2018), 0 descendants of its own

## Indications for use
HeRO is intended to acquire, store, analyze, and report on ECG data collected from infants. HeRO is intended to be used under the direct supervision of a licensed health care practitioner in a hospital neonatal or pediatric ICU environment. HeRO is intended to be used for the analysis of the variability in RR intervals (heart rate) and to report measurements of the variability of heart rate data (HRV). The HRV measurements reported by HeRO are specialized in nature, and intended to identify periods of transient decelerations and/or reduced baseline variability in the heart rate. HeRO is intended to provide only specialized HRV measurements and is not intended to produce any interpretation of those measurements or any kind of diagnosis. The specialized HRV measurements produced by HeRO have not been approved by the FDA for any specific clinical diagnosis. HeRO acquires data from a user-supplied ECG monitor, and requires a user-supplied local area network.

Source page: https://510kreport.com/device/K081473
Methodology: https://510kreport.com/methodology