# K080884: QHRV 1 - Health Assessment System

- Pathway: 510(k) (Traditional)
- Applicant: Medtechs, LLC
- Decided: Apr 11, 2008 after 11 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: 2 generations back to K950779 (1995). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973426: Ans 2000 Ecg Monitor and Respiration Pacer, D. E. Hokanson, Inc. (1998) Summary page 1.
- K972991: Monitor One NDX, Qmed, Inc. (1998) Summary page 1.
- K010955: BMT Anscore Health Management System, Boston Medical Technologies, Inc. (2001) Summary page 1.

## Most influential descendants
- K083735: Ansha Autonomic Nervous System Health Assessment Plus (2009), 2 descendants of its own
- K101983: Critical Care Assessment (2010), 1 descendant of its own
- K191266: VitalScan ANS (2020), 0 descendants of its own

## Indications for use
The QHRV 1 - Health Assessment System is intended for (HRV) Heart Rate Variability Measurements in response to a series of paced respiration, standardized and controlled exercises. These measurements and analysis are not intended as clinical diagnosis but only to substantiate appropriate patient health assessment procedures.

Source page: https://510kreport.com/device/K080884
Methodology: https://510kreport.com/methodology