# K092809: HRV Acquire

- Pathway: 510(k) (Abbreviated)
- Applicant: Wr Medical Electronics Co.
- Decided: Oct 19, 2010 after 403 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
Longest line of descent: 5 generations back to K950779 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941252: Respiratory and Cardiac Spectral Frequency Signal Processor, Ansar (1995) Summary page 1.
- K070795: Sphygmocor Cardiovascular Management System, Atcor Medical Pty, Ltd. (2007) Summary page 1.
- K882118: Model 700 Patient Monitor, Ivy Biomedical Systems, Inc. (1988) Summary page 1.
- K023616: Physiological Monitor, Model 3000 (Series), Ivy Biomedical Systems, Inc. (2002) Summary page 1.

## Indications for use
The Heart Rate Variability (HRV) Acquire device is intended to record and indicate the following parameters during autonomic testing maneuvers: - Expiratory pressure recording and display - Respiratory effort - Breathing cue metronome - Heart rate via electrocardiography (ECG) - Non-invasive beat-to-beat blood pressure from optional external device The HRV Acquire does not make a diagnosis or indicate by itself any disease state exists. The HRV Acquire is not designed for vital signs monitoring or self monitoring of patients.

Source page: https://510kreport.com/device/K092809
Methodology: https://510kreport.com/methodology