HeRO
by Medical Predictive Science Corp.
510(k) K111601
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK111601 | Date8 Jul 2011 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DPS
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2340
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The HeRO is a Cardiovascular Monitoring Device (Product Code: DPS) designed for continuous, non-invasive monitoring of neonatal patients. It integrates physiological data to assess the stability and risk of premature infants, enabling early detection of potential complications such as apnea or bradycardia. By providing real-time analytics, it supports clinical decision-making to optimize patient care in neonatal intensive care units (NICUs).
HeRO is supplied as a standalone bedside device or as a HeRO duet, accommodating two patients simultaneously. It connects to existing physiological monitors and operates in a non-sterile, reusable configuration, requiring no single-use components. The device is intended for use in regulated clinical settings, adhering to FDA clearance under 510(k) K111601 with a Special Substantial Equivalence (SESE) determination by the Cardiovascular (CV) Advisory Committee. Storage and maintenance follow manufacturer guidelines to ensure accurate and reliable performance.
Other devices from Medical Predictive Science Corp.
Questions
AI-generated answers, 20 Sep 2026
What types of neonatal patients is the HeRO designed to monitor, and how does it help clinicians?
The HeRO is specifically designed for continuous, non-invasive monitoring of premature infants in neonatal intensive care units (NICUs). It integrates physiological data to assess stability and risk, enabling early detection of complications like apnea or bradycardia. By providing real-time analytics, it supports clinicians in making data-driven decisions to optimize patient care and intervene proactively.
Is the HeRO device single-use or reusable, and what does that mean for my NICU’s workflow?
The HeRO is non-sterile and reusable, meaning it does not require single-use components or disposable parts. This design allows for long-term use in your NICU, reducing waste and streamlining maintenance. However, storage and maintenance must follow the manufacturer’s guidelines to ensure accurate and reliable performance over time.
Can the HeRO monitor more than one patient at a time, and if so, how does that work?
Yes, the HeRO is available in two configurations: a standalone device for single-patient monitoring or a HeRO duet, which can simultaneously monitor two patients. This dual-patient setup is ideal for NICUs with limited space or high patient volumes, allowing for efficient resource allocation while maintaining continuous, non-invasive monitoring.
How does the HeRO connect to existing equipment in the NICU, and does it require any special setup?
The HeRO is designed to integrate with existing physiological monitors in your NICU, meaning it can be easily incorporated into your current workflow without requiring additional hardware. Its non-invasive design and real-time analytics ensure compatibility with standard monitoring systems, reducing the need for complex installations or modifications.
What regulatory pathway does the HeRO follow, and how does that affect its use in clinical settings?
The HeRO received FDA clearance under 510(k) K111601 with a Special Substantial Equivalence (SESE) determination, reviewed by the Cardiovascular (CV) Advisory Committee. This means it has been evaluated for safety and effectiveness in its intended use—continuous, non-invasive monitoring of neonatal patients—and is approved for use in regulated clinical settings, such as NICUs, where strict protocols are followed.