# K972991: Monitor One NDX

- Pathway: 510(k) (Traditional)
- Applicant: Qmed, Inc.
- Decided: Dec 3, 1998 after 478 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: 1 generation back to K950779 (1995). 1 ancestor in all.
31 later devices descend from it; 4 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950779: Heart Rate Variability Software Option, Spacelabs, Inc. (1995) Summary page 6.

## Most influential descendants
- K991831: BMT Anscore Health Management System, Model 1.1 (1999), 26 descendants of its own
- K993875: BMT Anscore Health Management System (2000), 17 descendants of its own
- K070795: Sphygmocor Cardiovascular Management System (2007), 16 descendants of its own
- K110603: Hypertension Management Software Claient Server (HMS-CS) (2011), 8 descendants of its own
- K080670: Modification to Sphygmocor Cardiovascular Management System (2008), 8 descendants of its own

## Indications for use
The monitor one nDx® is intended to measure time domain heart rate variability (HRV) in response to a series of standardized, controlled exercises on the part of the patient. While the monitor one nDx® has been shown to be safe and effective for the measurement of heart rate variability, it is not intended to be used as the basis for a specific clinical diagnosis. The clinical significance of HRV should be determined by the physician.

Source page: https://510kreport.com/device/K972991
Methodology: https://510kreport.com/methodology