510(k) · Cleared
ClearedBioflux Software II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotricity · DSH Recorder, Magnetic Tape, Medical
Cleared on Jul 29, 2020 as substantially equivalent to K162571 (Biotricity, Inc., 2016) after a 119-day review. Its family tree reaches back 10 generations to 1994.
- Decided
- Jul 29, 2020
- Review
- 119 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K941811 (1994). 38 ancestors in all, the oldest K822695 (1982). No later device cites it as a predicate yet.
- Root · 10 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 6 generations between
- 3 generations backK111320 GlobalcardioCardiocomm Solutions, Inc. · 2011
- 2 generations backK122632 Guava IICardiocomm Solutions, Inc. · 2014
- 1 generation backK162571 Bioflux SoftwareBiotricity, Inc. · 2016
- This deviceK201040 Bioflux Software IIBiotricity · 2020
Show all 10 generations
- Root · 10 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 9 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 8 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 7 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 6 generations backK992636 HP Carevue 9000 Clinical Information System, Model M2331AHewlett-Packard Co. · 1999 · Recalled
- 5 generations backK073372 Electrophysiology Systems Integrator (Epsi)Systemsone · 2007
- 4 generations backK083321 Cardio-ViewCurlview Igt, LLC · 2008
- 3 generations backK111320 GlobalcardioCardiocomm Solutions, Inc. · 2011
- 2 generations backK122632 Guava IICardiocomm Solutions, Inc. · 2014
- 1 generation backK162571 Bioflux SoftwareBiotricity, Inc. · 2016
- This deviceK201040 Bioflux Software IIBiotricity · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −9 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −8 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −7 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −6 | K992636 | HP Carevue 9000 Clinical Information System, Model M2331A | Hewlett-Packard Co. | 1999 | 8 |
| −5 | K073372 | Electrophysiology Systems Integrator (Epsi) | Systemsone | 2007 | — |
| −4 | K083321 | Cardio-View | Curlview Igt, LLC | 2008 | — |
| −3 | K111320 | Globalcardio | Cardiocomm Solutions, Inc. | 2011 | — |
| −2 | K122632 | Guava II | Cardiocomm Solutions, Inc. | 2014 | — |
| −1 | K162571 | Bioflux Software | Biotricity, Inc. | 2016 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K162571 | Bioflux SoftwareSummary page 4…der Classification Number: 21 CFR 870.2800 Device Panel: Cardiovascular Regulatory Class: Class II Product Code: DSH 510(k): K162571 4. DEVICE DESCRIPTION Bioflux Software II is a browser based ECG viewer software that displays ECG records and… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 38 ancestors have a recall of any class.
How does its category compare?
All DSH devicesDSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 11 is intended to be used to view and annotate data acquired from diagnostic ECG sources of 1 to 3-leads. Bioflux Software Il is operated in a web browser and data is accessed via the users’ credentials on the hardware platform running the web browser. It will be used by cardiologists, general practitioners, cardiac, ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions. Bioflux Software II will…
Read the full statement (128 words)
Bioflux Software 11 is intended to be used to view and annotate data acquired from diagnostic ECG sources of 1 to 3-leads. Bioflux Software Il is operated in a web browser and data is accessed via the users’ credentials on the hardware platform running the web browser. It will be used by cardiologists, general practitioners, cardiac, ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions.
Bioflux Software II will be used in independent clinical testing facilities, clinics, hospitals, physician’s offices, or anywhere a physician or qualified practitioners deem appropriate.
Bioflux Software 11 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201040 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201040: Bioflux Software II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201040
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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