# K151781: Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor

- Pathway: 510(k) (Abbreviated)
- Applicant: Ivy Biomedical Systems, Inc.
- Decided: May 27, 2016 after 331 days
- Product code: DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Ivy Biomedical Model 7810 (“7810”) is a basic cardiac monitor used to provide cardiac and respiratory trigger pulse outputs used by third-party systems that require ECG or respiratory synchronization. Cardiac and respiratory synchronization is commonly used in diagnostic imaging modalities (i.e., nuclear medicine, computed axial (CAT), or positron emission (PET) tomography) or other applications requiring such synchronization. The 7810 is intended for use in pediatric and adult patients undergoing diagnostic imaging and related procedures in inpatient and outpatient centers under the supervision of licensed healthcare professionals. The product is not intended for use as a life support, home monitoring, or magnetic resonance imaging (MRI) modality. Patient Population The Model 7000 Series Cardiac Trigger Monitor is intended to perform ECG monitoring and R-wave pulse detection on adult, geriatric, pediatric and neonatal patients. R-Wave synchronization is typically used for gating nuclear scanners, CT scanners, or other imaging devices. Contraindications The Model 7000 Series is limited to use by trained and qualified medical professionals. This device is not intended for use as life support equipment or for performing cardiac diagnostics. The product is not intended for use in home care monitoring or for use in an MRI environment.

Source page: https://510kreport.com/device/K151781
Methodology: https://510kreport.com/methodology