510(k) · Cleared
ClearedHERO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Decision Networks · DPS Electrocardiograph
Cleared on May 9, 2003 as substantially equivalent to K991786 (General Electric Medical Systems Information Techn, 1999) after a 386-day review. Its family tree reaches back 2 generations to 1992. 6 later devices descend from it.
- Decided
- May 9, 2003
- Review
- 386 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K922171 (1992). 3 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK922171 Centra II Analysis SystemMarquette Electronics, Inc. · 1992
- 1 generation backK991786 Mars Unity Workstation with Heart Rate Variability (HRV) OptionGeneral Electric Medical Systems Information Techn · 1999
- This deviceK021230 HEROMedical Decision Networks · 2003
- Descendant · cites it directly · 2 of its ownK081473 Hero, Version 2.0Medical Predictive Science Corp. · 2008
- Descendant · 2 generations on · 1 of its ownK111601 HEROMedical Predictive Science Corp. · 2011
- Descendant · cites it directly · 1 of its ownK062068 Intelwave Heart Rate Variability System, Version 1.0Intelwave, LLC · 2006
- Descendant · 3 generations on · 0 of its ownK180242 HeRO Symphony, HeRO ES, HeRO solo/duetMedical Predictive Science Corporation · 2018
- Descendant · cites it directly · 0 of its ownK142551 QANS (Quantitative Autonomic Nervous System) Monitoring SystemHhssystems, LLC · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K081473Hero, Version 2.0Medical Predictive Science Corp. · 2008 · cites it directly2descendants
- K111601HEROMedical Predictive Science Corp. · 2011 · 2 generations on1descendant
- K062068Intelwave Heart Rate Variability System, Version 1.0Intelwave, LLC · 2006 · cites it directly1descendant
- K180242HeRO Symphony, HeRO ES, HeRO solo/duetMedical Predictive Science Corporation · 2018 · 3 generations on0descendants
- K142551QANS (Quantitative Autonomic Nervous System) Monitoring SystemHhssystems, LLC · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922171 | Centra II Analysis System | Marquette Electronics, Inc. | 1992 | — |
| −1 | K991786 | Mars Unity Workstation with Heart Rate Variability (HRV) Option | General Electric Medical Systems Information Techn | 1999 | — |
| 0 (this device) | K021230 | HERO | Medical Decision Networks | 2003 | — |
| +1 | K081473 | Hero, Version 2.0 | Medical Predictive Science Corp. | 2008 | — |
| +2 | K111601 | HERO | Medical Predictive Science Corp. | 2011 | — |
| +1 | K062068 | Intelwave Heart Rate Variability System, Version 1.0 | Intelwave, LLC | 2006 | — |
| +3 | K180242 | HeRO Symphony, HeRO ES, HeRO solo/duet | Medical Predictive Science Corporation | 2018 | — |
| +1 | K142551 | QANS (Quantitative Autonomic Nervous System) Monitoring System | Hhssystems, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 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? (1)
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 |
|---|---|---|---|
| * | K991786 | Mars Unity Workstation with Heart Rate Variability (HRV) OptionSummary page 1…HRV Analysis System Classification Name: Electrocardiograph Classification Number: 21CFR 870.2340 74DPS, Class I1 Predicate Device: K99 1786 GE Marquette MARS Unity Workstation with Heart Rate Variability (HR… | 1999 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K081473 (Medical Predictive Science Corp., 2008) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K991786.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
HERO is intended to acquire, store, analyze, and report on ECG data collected from infants. HERO is intended to be used under the direct supervision of a licensed health care practitioner in a hospital neonatal or pediatric ICU environment. HERO is intended to be used for the analysis of the variability in RR intervals (heart rate) and to report measurements of the variability of heart rate data (HRV). The HRV measurements reported by HERO are…
Read the full statement (153 words)
HERO is intended to acquire, store, analyze, and report on ECG data collected from infants. HERO is intended to be used under the direct supervision of a licensed health care practitioner in a hospital neonatal or pediatric ICU environment.
HERO is intended to be used for the analysis of the variability in RR intervals (heart rate) and to report measurements of the variability of heart rate data (HRV). The HRV measurements reported by HERO are specialized in nature, and intended to identify periods of transient decelerations and/or reduced baseline variability in the heart rate.
HERO is intended to provide only specialized HRV measurements and is not intended to produce any interpretation of those measurements or any kind of diagnosis.
The specialized HRV measurements produced by HERO have not been approved by the FDA for any specific clinical diagnosis.
HERO acquires data from a user-supplied ECG monitor, and requires a user-supplied local area network.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021230 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021230: HERO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021230
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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