510(k) · Cleared
ClearedBiomonitor III, Biomonitor IIIm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotronik, Inc. · MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Cleared on Dec 8, 2020 as substantially equivalent to K200444 (Biotronik, Inc., 2020) after a 155-day review. Its family tree reaches back 12 generations to 1987. 3 later devices descend from it.
- Decided
- Dec 8, 2020
- Review
- 155 days
- Class
- Class II
- Product code
- MXD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K864889 (1987). 60 ancestors in all, the oldest K832113 (1983). 3 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK864889 Omni-TrakInvivo Research Labs, Inc. · 1987
- 8 generations between
- 3 generations backK152995 BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc. · 2016
- 2 generations backK190548 BIOMONITOR III, Remote Assistant IIIBiotronik, Inc. · 2019
- 1 generation backK200444 Biomonitor III, Biomonitor IIImBiotronik, Inc. · 2020
- This deviceK201865 Biomonitor III, Biomonitor IIImBiotronik, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK221856 BIOMONITOR IIIm, BIOMONITOR IIIBiotronik, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK230375 Biomonitor IVBiotronik, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK261074 Biomonitor IV (471155)Biotronik, Inc. · 2026
Show all 12 generations
- Root · 12 generations backK864889 Omni-TrakInvivo Research Labs, Inc. · 1987
- 11 generations backK950264 MaglifeOdam · 1996
- 10 generations backK023195 Maglife C/Maglife C PlusSchiller Medical S.A. · 2003
- 9 generations backK040915 Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc. · 2004
- 8 generations backK050399 Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005
- 7 generations backK053462 3160 Mri Patient Monitoring SystemInvivo Corporation · 2006 · Recalled
- 6 generations backK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
- 5 generations backK132960 BiomonitorBiotronik, Inc. · 2014
- 4 generations backK143503 BioMonitorBiotronik, Inc. · 2015
- 3 generations backK152995 BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc. · 2016
- 2 generations backK190548 BIOMONITOR III, Remote Assistant IIIBiotronik, Inc. · 2019
- 1 generation backK200444 Biomonitor III, Biomonitor IIImBiotronik, Inc. · 2020
- This deviceK201865 Biomonitor III, Biomonitor IIImBiotronik, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K864889 | Omni-Trak | Invivo Research Labs, Inc. | 1987 | — |
| −11 | K950264 | Maglife | Odam | 1996 | — |
| −10 | K023195 | Maglife C/Maglife C Plus | Schiller Medical S.A. | 2003 | — |
| −9 | K040915 | Magnitude 3150M Mri Patient Monitor, Model 3150M | Invivo Research, Inc. | 2004 | — |
| −8 | K050399 | Mri Compatible Patient Monitoring System, Model 3160 | Invivo Research, Inc. | 2005 | — |
| −7 | K053462 | 3160 Mri Patient Monitoring System | Invivo Corporation | 2006 | 2 |
| −6 | K071641 | Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model… | Medtronic, Inc. | 2007 | — |
| −5 | K132960 | Biomonitor | Biotronik, Inc. | 2014 | — |
| −4 | K143503 | BioMonitor | Biotronik, Inc. | 2015 | — |
| −3 | K152995 | BioMonitor 2-AF, BioMonitor 2-S | Biotronik, Inc. | 2016 | — |
| −2 | K190548 | BIOMONITOR III, Remote Assistant III | Biotronik, Inc. | 2019 | — |
| −1 | K200444 | Biomonitor III, Biomonitor IIIm | Biotronik, Inc. | 2020 | — |
| 0 (this device) | K201865 | Biomonitor III, Biomonitor IIIm | Biotronik, Inc. | 2020 | — |
| +1 | K221856 | BIOMONITOR IIIm, BIOMONITOR III | Biotronik, Inc. | 2022 | — |
| +2 | K230375 | Biomonitor IV | Biotronik, Inc. | 2023 | — |
| +3 | K261074 | Biomonitor IV (471155) | Biotronik, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 7 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 7 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 MXD? 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 MXD device
- #1 K262735 LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)score 16.7 · 17 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 |
|---|---|---|---|
| * | K200444 | Biomonitor III, Biomonitor IIImSummary page 4…Arrhythmia Detection) Classification Class II (21 CFR 870.1025) Product Code MXD 3. Predicate Device BIOTRONIK BIOMONITOR III and BIOMONITOR IIIm, K200444, cleared April 23, 2020 Page 1 of 4… | 2020 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221856 | BIOMONITOR IIIm, BIOMONITOR III | 2022 | 2 |
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 33 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 60 ancestors have a recall of any class.
- Of its descendants, K221856 (Biotronik, Inc., 2022) has gone furthest, with 2 descendants of its own.
How does its category compare?
All MXD devicesMXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection): FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MXD
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MXD
36in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MXD
5so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MXD
3,384in 2025
MAUDE reports naming product code MXD, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 3 | 63 | 0 | 21 |
| 2017 | 4 | 52 | 0 | 37 |
| 2018 | 0 | — | 0 | 32 |
| 2019 | 1 | — | 0 | 70 |
| 2020 | 4 | 127 | 0 | 228 |
| 2021 | 4 | 57 | 0 | 694 |
| 2022 | 2 | — | 1 | 1,362 |
| 2023 | 6 | 76 | 1 | 1,766 |
| 2024 | 1 | — | 1 | 3,019 |
| 2025 | 3 | 36 | 0 | 3,384 |
| 2026 | 2 | — | 5 | — |
What is it indicated for?
The BIOMONITOR III/BIOMONITOR IIIm is indicated to detect the following cardiac arrhythmias:
» atrial fibrillation
* bradycardia
* sudden rate drop
* high ventricular rate (HVR)
* asystole
The BIOMONITOR III/BIOMONITOR IIIm is indicated for use in:
» Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
» Patients who experience transient symptoms that may suggest a cardiac arrhythmia
The device has not been tested for and it is not intended for pediatric use.
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/K201865 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201865: Biomonitor III, Biomonitor IIIm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201865
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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