# K991786: Mars Unity Workstation with Heart Rate Variability (HRV) Option

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Medical Systems Information Techn
- Decided: Nov 18, 1999 after 177 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 K922171 (1992). 2 ancestors in all.
64 later devices descend from it; 6 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922171: Centra II Analysis System, Marquette Electronics, Inc. (1992) Summary page 1.
- K950779: Heart Rate Variability Software Option, Spacelabs, Inc. (1995) Summary page 1.

## Most influential descendants
- K042108: Vista Plus (2005), 46 descendants of its own
- K071641: Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539) (2007), 40 descendants of its own
- K071655: Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538 (2007), 30 descendants of its own
- K082475: Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor, Model 9528 (2008), 28 descendants of its own
- K103764: Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac Monitor, Model 9528 (2011), 26 descendants of its own

## Indications for use
The MARS Unity Workstation is intended to acquire, analyze, edit, review, report and store ambulatory and monitoring network ECG and mulfiparameter data. The MARS Unity Workstation is intended to be used by trained operators under the direct supervision of a licensed health care practitioner in a hospital or clinic environment. Patient population includes both adult and pediatric. The Heart Rate Variability (HRV) Option is intended to be used for the analysis of the variability in RR intervals (heart rate) and to report measurements of the variability heart rate data. Heart Rate Variability (HRV) Option is intended to provide only HRV measurements and is not intended to produce any interpretation of those measurements or any kind of diagnosis. The HRV measurements produced by Heart Rate Variability (HRV} Option are intended to be used by quadlified personnel in evaluating the patient in conjunction with patient's clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgement. The HRYV feature of this device has not been shown to be safe and effective for a specific clinical diagnosis.

Source page: https://510kreport.com/device/K991786
Methodology: https://510kreport.com/methodology