510(k) · Cleared
ClearedHRV Acquire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wr Medical Electronics Co. · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cleared on Oct 19, 2010 as substantially equivalent to K941252 (Ansar, 1995) and 3 other predicates after a 403-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Oct 19, 2010
- Review
- 403 days
- Class
- Class II
- Product code
- DRT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K950779 (1995). 12 ancestors in all, the oldest K882118 (1988). No later device cites it as a predicate yet.
- Root · 5 generations backK950779 Heart Rate Variability Software OptionSpacelabs, Inc. · 1995
- 4 generations backK972991 Monitor One NDXQmed, Inc. · 1998
- 3 generations backK991831 BMT Anscore Health Management System, Model 1.1Boston Medical Technologies, Inc. · 1999
- 2 generations backK993875 BMT Anscore Health Management SystemBoston Medical Technologies, Inc. · 2000
- 1 generation backK070795 Sphygmocor Cardiovascular Management SystemAtcor Medical Pty, Ltd. · 2007
- This deviceK092809 HRV AcquireWr Medical Electronics Co. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K950779 | Heart Rate Variability Software Option | Spacelabs, Inc. | 1995 | — |
| −4 | K972991 | Monitor One NDX | Qmed, Inc. | 1998 | — |
| −3 | K991831 | BMT Anscore Health Management System, Model 1.1 | Boston Medical Technologies, Inc. | 1999 | — |
| −2 | K993875 | BMT Anscore Health Management System | Boston Medical Technologies, Inc. | 2000 | — |
| −1 | K070795 | Sphygmocor Cardiovascular Management System | Atcor Medical Pty, Ltd. | 2007 | — |
| 0 (this device) | K092809 | HRV Acquire | Wr Medical Electronics Co. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DRT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DRT device
- #1 K252676 The Circadia C300 System (C300)score 15.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K941252 | Respiratory and Cardiac Spectral Frequency Signal ProcessorSummary page 1…Heart Rate Variability Device Classification Name: Cardiac monitor, 21 CFR 870.2300, Product Code: DRT, Class II Predicate Device(s): K941252, ANX 3.0 K070795, SphygmoCorTm Cardiac Vascular Management System… | 1995 |
| * | K070795 | Sphygmocor Cardiovascular Management SystemSummary page 1…ssification Name: Cardiac monitor, 21 CFR 870.2300, Product Code: DRT, Class II Predicate Device(s): K941252, ANX 3.0 K070795, SphygmoCorTm Cardiac Vascular Management System K8821 18, K023616, IVY ECG 1.0 Description o… | 2007 |
| * | K882118 | Model 700 Patient MonitorSummary page 1…Predicate Device(s): K941252, ANX 3.0 K070795, SphygmoCorTm Cardiac Vascular Management System K8821 18, K023616, IVY ECG 1.0 Description of Device The HRV Acquire (HRV) Device with Test Works software can be used as a stand… | 1988 |
| * | K023616 | Physiological Monitor, Model 3000 (Series)Summary page 1…te Device(s): K941252, ANX 3.0 K070795, SphygmoCorTm Cardiac Vascular Management System K8821 18, K023616, IVY ECG 1.0 Description of Device The HRV Acquire (HRV) Device with Test Works software can be used as a standalone… | 2002 |
| † | K880572 | Ohmeda 2350 Finapres (R) Blood Pressure Monitor | 1988 |
| † | K992874 | Q-Sweat Quantitative Sweat Measurement System | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 1 other device also cites its predicate K941252.
How does its category compare?
All DRT devicesDRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DRT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRT
228in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRT
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRT
40in 2025
MAUDE reports naming product code DRT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 113 |
| 2008 | 1 | — | 0 | 99 |
| 2009 | 6 | 70 | 0 | 118 |
| 2010 | 3 | 44 | 0 | 63 |
| 2011 | 3 | 149 | 1 | 36 |
| 2012 | 1 | — | 0 | 47 |
| 2013 | 1 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 26 |
| 2015 | 1 | — | 0 | 48 |
| 2016 | 1 | — | 0 | 55 |
| 2017 | 1 | — | 0 | 159 |
| 2018 | 1 | — | 0 | 224 |
| 2019 | 1 | — | 0 | 447 |
| 2020 | 0 | — | 0 | 50 |
| 2021 | 2 | — | 1 | 85 |
| 2022 | 1 | — | 0 | 35 |
| 2023 | 1 | — | 0 | 47 |
| 2024 | 3 | 228 | 1 | 29 |
| 2025 | 1 | — | 0 | 40 |
| 2026 | 5 | 120 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092809 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092809: HRV Acquire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092809
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026