510(k) · Cleared
ClearedHero, Version 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Predictive Science Corp. · DPS Electrocardiograph
Cleared on Jun 27, 2008 as substantially equivalent to K021230 (Medical Decision Networks, 2003) after a 31-day review. Its family tree reaches back 3 generations to 1992. 2 later devices descend from it.
- Decided
- Jun 27, 2008
- Review
- 31 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K922171 (1992). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK922171 Centra II Analysis SystemMarquette Electronics, Inc. · 1992
- 2 generations backK991786 Mars Unity Workstation with Heart Rate Variability (HRV) OptionGeneral Electric Medical Systems Information Techn · 1999
- 1 generation backK021230 HEROMedical Decision Networks · 2003
- This deviceK081473 Hero, Version 2.0Medical Predictive Science Corp. · 2008
- Descendant · cites it directly · 1 of its ownK111601 HEROMedical Predictive Science Corp. · 2011
- Descendant · 2 generations on · 0 of its ownK180242 HeRO Symphony, HeRO ES, HeRO solo/duetMedical Predictive Science Corporation · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922171 | Centra II Analysis System | Marquette Electronics, Inc. | 1992 | — |
| −2 | K991786 | Mars Unity Workstation with Heart Rate Variability (HRV) Option | General Electric Medical Systems Information Techn | 1999 | — |
| −1 | K021230 | HERO | Medical Decision Networks | 2003 | — |
| 0 (this device) | K081473 | Hero, Version 2.0 | Medical Predictive Science Corp. | 2008 | — |
| +1 | K111601 | HERO | Medical Predictive Science Corp. | 2011 | — |
| +2 | K180242 | HeRO Symphony, HeRO ES, HeRO solo/duet | Medical Predictive Science Corporation | 2018 | — |
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 |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K021230 | HEROSummary page 1…HRV Analysis System Classification Name: Electrocardiograph Classification Number: 21CFR 870.2340 74DPS, Class II Predicate Device: K02 1230 (HeRO) Device Description: HeRO Version 2.0 is comprised of off-the-shelf Personal Computer… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111601 | HERO | 2011 | 1 |
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 16 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K111601 (Medical Predictive Science Corp., 2011) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K021230.
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?
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/K081473 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081473: Hero, Version 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081473
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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