510(k) · Cleared
ClearedQHRV 1 - Health Assessment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtechs, LLC · DPS Electrocardiograph
Cleared on Apr 11, 2008 as substantially equivalent to K973426 (D. E. Hokanson, Inc., 1998) and 2 other predicates after an 11-day review. Its family tree reaches back 2 generations to 1995. 3 later devices descend from it.
- Decided
- Apr 11, 2008
- Review
- 11 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K950779 (1995). 4 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK950779 Heart Rate Variability Software OptionSpacelabs, Inc. · 1995
- 1 generation backK972991 Monitor One NDXQmed, Inc. · 1998
- This deviceK080884 QHRV 1 - Health Assessment SystemMedtechs, LLC · 2008
- Descendant · cites it directly · 2 of its ownK083735 Ansha Autonomic Nervous System Health Assessment PlusMedtechs, LLC · 2009
- Descendant · 2 generations on · 1 of its ownK101983 Critical Care AssessmentCritical Patient Care, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK191266 VitalScan ANSMedeia, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950779 | Heart Rate Variability Software Option | Spacelabs, Inc. | 1995 | — |
| −1 | K972991 | Monitor One NDX | Qmed, Inc. | 1998 | — |
| 0 (this device) | K080884 | QHRV 1 - Health Assessment System | Medtechs, LLC | 2008 | — |
| +1 | K083735 | Ansha Autonomic Nervous System Health Assessment Plus | Medtechs, LLC | 2009 | — |
| +2 | K101983 | Critical Care Assessment | Critical Patient Care, Inc. | 2010 | — |
| +2 | K191266 | VitalScan ANS | Medeia, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2020 | 1 | 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 DPS? 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 DPS device
- #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K973426 | Ans 2000 Ecg Monitor and Respiration PacerSummary page 1…Substantial Equivalence: QHRV-l is substantially equivalent to the following Predicate Device systems. Hokanson ANS 2000 RR Interval Measurement K973426 Q Med Inc., Monitor One NDX HRV Analysis Function K972991 Ansore Health Management System - Boston Medical… | 1998 |
| * | K972991 | Monitor One NDXSummary page 1…ollowing Predicate Device systems. Hokanson ANS 2000 RR Interval Measurement K973426 Q Med Inc., Monitor One NDX HRV Analysis Function K972991 Ansore Health Management System - Boston Medical K01 0955 Intended Use: QHRV-1 Health Assessment System has the… | 1998 |
| * | K010955 | BMT Anscore Health Management SystemSummary page 1…rement K973426 Q Med Inc., Monitor One NDX HRV Analysis Function K972991 Ansore Health Management System - Boston Medical K01 0955 Intended Use: QHRV-1 Health Assessment System has the same intended use as the legally marketed predicate device systems. The… | 2001 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083735 | Ansha Autonomic Nervous System Health Assessment Plus | 2009 | 2 |
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 13 years and passes through 3 companies; a new generation was cleared every 9.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K083735 (Medtechs, LLC, 2009) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K973426.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, 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 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080884 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080884: QHRV 1 - Health Assessment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080884
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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