510(k) · Cleared
ClearedBioflux Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotricity, Inc. · DSH Recorder, Magnetic Tape, Medical
Cleared on Oct 13, 2016 as substantially equivalent to K122632 (Cardiocomm Solutions, Inc., 2014) after a 28-day review. Its family tree reaches back 9 generations to 1994. 1 later device descends from it.
- Decided
- Oct 13, 2016
- Review
- 28 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K941811 (1994). 37 ancestors in all, the oldest K822695 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 5 generations between
- 3 generations backK083321 Cardio-ViewCurlview Igt, LLC · 2008
- 2 generations backK111320 GlobalcardioCardiocomm Solutions, Inc. · 2011
- 1 generation backK122632 Guava IICardiocomm Solutions, Inc. · 2014
- This deviceK162571 Bioflux SoftwareBiotricity, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK201040 Bioflux Software IIBiotricity · 2020
Show all 9 generations
- Root · 9 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 8 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 7 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 6 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 5 generations backK992636 HP Carevue 9000 Clinical Information System, Model M2331AHewlett-Packard Co. · 1999 · Recalled
- 4 generations backK073372 Electrophysiology Systems Integrator (Epsi)Systemsone · 2007
- 3 generations backK083321 Cardio-ViewCurlview Igt, LLC · 2008
- 2 generations backK111320 GlobalcardioCardiocomm Solutions, Inc. · 2011
- 1 generation backK122632 Guava IICardiocomm Solutions, Inc. · 2014
- This deviceK162571 Bioflux SoftwareBiotricity, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K201040Bioflux Software IIBiotricity · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −8 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −7 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −6 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −5 | K992636 | HP Carevue 9000 Clinical Information System, Model M2331A | Hewlett-Packard Co. | 1999 | 8 |
| −4 | K073372 | Electrophysiology Systems Integrator (Epsi) | Systemsone | 2007 | — |
| −3 | K083321 | Cardio-View | Curlview Igt, LLC | 2008 | — |
| −2 | K111320 | Globalcardio | Cardiocomm Solutions, Inc. | 2011 | — |
| −1 | K122632 | Guava II | Cardiocomm Solutions, Inc. | 2014 | — |
| 0 (this device) | K162571 | Bioflux Software | Biotricity, Inc. | 2016 | — |
| +1 | K201040 | Bioflux Software II | Biotricity | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 DSH? 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 DSH device
- #1 K260157 LifeLens Physiological Monitorscore 17.9 · 22 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 |
|---|---|---|---|
| * | K122632 | Guava IISummary page 4…alent in intended use and similar technological characteristics the following device, CardioComm Solutions, Inc. Guava II which was cleared under K122632. K162571 - Page 2 of 6 IV. DEVICE DESCRIPTION Bioflux software is an API based ECG viewer… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201040 | Bioflux Software II | 2020 | 0 |
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 22 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 37 ancestors have a recall of any class.
- Of its descendants, K201040 (Biotricity, 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DSH devicesDSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · DSH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSH
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSH
No recall names DSH since 2007.
Adverse event reports per year · DSH
213in 2025
MAUDE reports naming product code DSH, 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 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 84 | 0 | 1 |
| 2010 | 2 | — | 0 | 8 |
| 2011 | 6 | 64 | 0 | 3 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 8 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 3 | 91 | 0 | 31 |
| 2018 | 3 | 269 | 0 | 30 |
| 2019 | 3 | 30 | 0 | 76 |
| 2020 | 4 | 122 | 0 | 91 |
| 2021 | 4 | 263 | 0 | 113 |
| 2022 | 4 | 427 | 0 | 46 |
| 2023 | 6 | 198 | 0 | 65 |
| 2024 | 2 | — | 0 | 88 |
| 2025 | 4 | 205 | 0 | 213 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Bioflux software is intended to be used to analyze, view, and report ECG data acquired from a variety of ECG sources including single and 3-lead ECG devices. Bioflux software is operated locally in a browser and data is accessed via the users’ credentials on the hardware platform running the browser. It will be used by cardiologists, general practitioners, cardiac, or ECG technicians, nurses, monitoring service technicians, and other cardiac related…
Read the full statement (129 words)
Bioflux software is intended to be used to analyze, view, and report ECG data acquired from a variety of ECG sources including single and 3-lead ECG devices. Bioflux software is operated locally in a browser and data is accessed via the users’ credentials on the hardware platform running the browser.
It will be used by cardiologists, general practitioners, cardiac, or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions, or care givers, in independent clinical testing facilities, clinics, hospitals, physician’s offices, or anywhere a physician or qualified non-physician practitioners deems appropriate
Bioflux software does not offer diagnosis, or medical alarms. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgement and experience are used to check and interpret the data.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162571 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162571: Bioflux Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162571
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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