# K142551: QANS (Quantitative Autonomic Nervous System) Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Hhssystems, LLC
- Decided: Apr 16, 2015 after 218 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: 4 generations back to K922171 (1992). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903497: Flexcomp DSP & Procomp, Thought Technology, Ltd. (1991) Summary page 5.
- K021230: HERO, Medical Decision Networks (2003) Summary page 5.
- K062068: Intelwave Heart Rate Variability System, Version 1.0, Intelwave, LLC (2006) Summary page 5.

## Cited in the summary but kept off the family tree
- K972723: Bio Trol, Mindmedia Labs, Inc. (1997). Our reading of the summary gave K972723, FDA’s number for Bio Trol (Mindmedia Labs, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “BioGraph Infiniti and CardioPro software”. Kept off the family tree. Summary page 5.

## Indications for use
The intended use of the HHSsystems QANS (Quantitative Autonomic Nervous System) Monitoring System: QANS (Quantitative Autonomic Nervous System) Monitoring System is a physiological monitoring device that collects and transmits measurements (heart rate, respiration rate, and muscle activity) using sensors. The QANS monitoring system monitors the sympathetic and parasympathetic nervous system using accurate recordings of heart rate (HR) from EKG and provides statistical data as well as heart rate variability (HRV) data which the clinician can use it make clinical assessments of medical, dental or peak performance interventions. The physiological information can be used as a general patient monitoring system as well as for research. QANS is not intended to produce any interpretation of the measurements obtained and does not provide any type of diagnosis. Patients should be 5 years old or older.

Source page: https://510kreport.com/device/K142551
Methodology: https://510kreport.com/methodology