510(k) · Cleared
ClearedphysiQ Heart Rhythm Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Physiq, Inc. · DPS Electrocardiograph
Cleared on Aug 10, 2018 as substantially equivalent to K062282 (Monebo Technologies, Inc., 2007) after a 193-day review. Its family tree reaches back 4 generations to 2000. 7 later devices descend from it.
- Decided
- Aug 10, 2018
- Review
- 193 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K003621 (2000). 7 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK003621 ST/AR ST and Arrhythmia Software, Model Release D.0Agilent Technologies, Inc. · 2000
- 3 generations backK013717 Brentwood Real Time ST and Arrhythmia Analysis Software LibraryBrentwood Medical Technology Corp. · 2002
- 2 generations backK043380 Monebo Automatic Arrhythmia Detection Software Library, Version 1Monebo Technologies, Inc. · 2005
- 1 generation backK062282 Monebo Automated Ecg Analysis and Interpretation Software Library…Monebo Technologies, Inc. · 2007
- This deviceK180234 physiQ Heart Rhythm ModulePhysiq, Inc. · 2018
- Descendant · cites it directly · 4 of its ownK192004 Eko Analysis SoftwareEko Devices, Inc. · 2020
- Descendant · 2 generations on · 3 of its ownK213794 Eko Murmur Analysis Software (EMAS)Eko Devices, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK240901 StethophoneSparrow Acoustics, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK183322 physIQ Heart Rhythm and Respiratory ModulePhysiq, Inc. · 2019
- Descendant · 4 generations on · 0 of its ownK252595 Stethophone ProSparrow Acoustics, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K192004Eko Analysis SoftwareEko Devices, Inc. · 2020 · cites it directly4descendants
- K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc. · 2022 · 2 generations on3descendants
- K240901StethophoneSparrow Acoustics, Inc. · 2024 · 3 generations on1descendant
- K183322physIQ Heart Rhythm and Respiratory ModulePhysiq, Inc. · 2019 · cites it directly1descendant
- K252595Stethophone ProSparrow Acoustics, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003621 | ST/AR ST and Arrhythmia Software, Model Release D.0 | Agilent Technologies, Inc. | 2000 | — |
| −3 | K013717 | Brentwood Real Time ST and Arrhythmia Analysis Software Library | Brentwood Medical Technology Corp. | 2002 | — |
| −2 | K043380 | Monebo Automatic Arrhythmia Detection Software Library, Version 1 | Monebo Technologies, Inc. | 2005 | — |
| −1 | K062282 | Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0 | Monebo Technologies, Inc. | 2007 | — |
| 0 (this device) | K180234 | physiQ Heart Rhythm Module | Physiq, Inc. | 2018 | — |
| +1 | K192004 | Eko Analysis Software | Eko Devices, Inc. | 2020 | — |
| +2 | K213794 | Eko Murmur Analysis Software (EMAS) | Eko Devices, Inc. | 2022 | — |
| +3 | K240901 | Stethophone | Sparrow Acoustics, Inc. | 2024 | — |
| +1 | K183322 | physIQ Heart Rhythm and Respiratory Module | Physiq, Inc. | 2019 | — |
| +4 | K252595 | Stethophone Pro | Sparrow Acoustics, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 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 |
|---|---|---|---|
| * | K062282 | Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0Summary page 4…ion: Class II, 21 CFR§870.2340 (Electrocardiograph) Product Code: DPS Predicate Device” Monebo Automated ECG Analysis and Interpretation Software Library, Version 3.0 (K062282) Monebo Technologies Inc. Indications for Use: The physIQ Heart Rhythm Module (Version 1.0) is intended for use by a physician o… | 2007 |
| † | K152139 | Vital Connect Platform, HealthPatch MD, VitalPatch | 2015 |
| † | K121197 | Bodyguardian System Bodyguardian Control Unit Bodyguardian Connect | 2012 |
| † | K151188 | BodyGuardian Remote Monitoring System | 2015 |
What descends from it? (7)
2 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 18 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K192004 (Eko Devices, Inc., 2020) has gone furthest, with 4 descendants of its own.
- 8 other devices also cite its predicate K062282.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 physlQ Heart Rhythm Module is intended for use by a physician or other qualified medical professionals for the calculation of heart rate and heart rate variability and the detection of atrial fibrillation using ambulatory ECG data. The physlQ Heart Rhythm Module supports receiving and analyzing single-lead ECG signals recorded in a compatible format from FDA-cleared ECG biosensor devices using "wet" electrode technology when assessment of rhythm is…
Read the full statement (107 words)
The physlQ Heart Rhythm Module is intended for use by a physician or other qualified medical professionals for the calculation of heart rate and heart rate variability and the detection of atrial fibrillation using ambulatory ECG data. The physlQ Heart Rhythm Module supports receiving and analyzing single-lead ECG signals recorded in a compatible format from FDA-cleared ECG biosensor devices using "wet" electrode technology when assessment of rhythm is desired. The physlQ Heart Rhythm Module is for use in subacute clinical and non-clinical settings for remote patient monitoring. The physlQ Heart Rhythm Module is not for use in patients requiring life-supporting or life-sustaining systems or ECG Alarm devices,
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K180234 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180234: physiQ Heart Rhythm Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180234
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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