510(k) · Cleared
ClearedBiotres
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotricity · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on Jul 28, 2022 as substantially equivalent to K211709 (Biotricity, 2022) after a 20-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Jul 28, 2022
- Review
- 20 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K950944 (1996). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK950944 Ambulatory (Holter) Recording SystemBiosensor Corp. · 1996
- 6 generations backK993618 DXP1000 Holter RecorderBraemar Corp. · 1999
- 5 generations backK113176 Mysense HeartCardiac Science Corporation · 2011
- 4 generations backK131190 MypatchDms-Service, LLC · 2013
- 3 generations backK160704 myPatch-sDms-Service, LLC · 2016
- 2 generations backK171410 ePatchBraemar Manufacturing, LLC · 2018
- 1 generation backK211709 BiotresBiotricity · 2022
- This deviceK222017 BiotresBiotricity · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K950944 | Ambulatory (Holter) Recording System | Biosensor Corp. | 1996 | — |
| −6 | K993618 | DXP1000 Holter Recorder | Braemar Corp. | 1999 | — |
| −5 | K113176 | Mysense Heart | Cardiac Science Corporation | 2011 | — |
| −4 | K131190 | Mypatch | Dms-Service, LLC | 2013 | — |
| −3 | K160704 | myPatch-s | Dms-Service, LLC | 2016 | — |
| −2 | K171410 | ePatch | Braemar Manufacturing, LLC | 2018 | — |
| −1 | K211709 | Biotres | Biotricity | 2022 | — |
| 0 (this device) | K222017 | Biotres | Biotricity | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 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 MWJ? 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 MWJ device
- #1 K254119 Wearable ECG Recorder (YMHeart XY-12)…score 14.1 · 8 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 |
|---|---|---|---|
| * | K211709 | BiotresSummary page 4…ry (without Analysis) III. PREDICATE DEVICE The Biotres (Biotricity) was cleared under K211709. Name of Device: Biotres Classification Regulation: 21 CFR§870.28… | 2022 |
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 6 companies; a new generation was cleared every 2.7 years on median.
- None of the 9 ancestors has a recall.
- 1 other device also cites its predicate K211709.
How does its category compare?
All MWJ devicesMWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · MWJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MWJ
337in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWJ
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWJ
8in 2025
MAUDE reports naming product code MWJ, 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 | 5 | 142 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 3 | 90 | 0 | 0 |
| 2011 | 3 | 206 | 0 | 0 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 3 | 241 | 0 | 4 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 4 | 337 | 0 | 6 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 2 | — | 2 | 3 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 5 | 270 | 0 | — |
What is it indicated for?
The Biotres is indicated for use on adult patients 18 years or older who may be asymptomatic or who suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, syncope, fatigue, chest pain and/or anxiety and may require cardiac recording on a continuous basis for up to 30 days. The signal acquired by the Biotres is not intended and should not be used for automated or semi-automated analysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222017 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222017: Biotres.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222017
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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