510(k) · Cleared
ClearedBIOMONITOR III, Remote Assistant III
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 Jul 5, 2019 as substantially equivalent to K152995 (Biotronik, Inc., 2016) after a 122-day review. Its family tree reaches back 10 generations to 1987. 5 later devices descend from it.
- Decided
- Jul 5, 2019
- Review
- 122 days
- Class
- Class II
- Product code
- MXD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K864889 (1987). 58 ancestors in all, the oldest K832113 (1983). 5 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK864889 Omni-TrakInvivo Research Labs, Inc. · 1987
- 6 generations between
- 3 generations backK132960 BiomonitorBiotronik, Inc. · 2014
- 2 generations backK143503 BioMonitorBiotronik, Inc. · 2015
- 1 generation backK152995 BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc. · 2016
- This deviceK190548 BIOMONITOR III, Remote Assistant IIIBiotronik, Inc. · 2019
- Descendant · cites it directly · 4 of its ownK200444 Biomonitor III, Biomonitor IIImBiotronik, Inc. · 2020
- Descendant · 2 generations on · 3 of its ownK201865 Biomonitor III, Biomonitor IIImBiotronik, Inc. · 2020
- Descendant · 3 generations on · 2 of its ownK221856 BIOMONITOR IIIm, BIOMONITOR IIIBiotronik, Inc. · 2022
- Descendant · 4 generations on · 1 of its ownK230375 Biomonitor IVBiotronik, Inc. · 2023
- Descendant · 5 generations on · 0 of its ownK261074 Biomonitor IV (471155)Biotronik, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK864889 Omni-TrakInvivo Research Labs, Inc. · 1987
- 9 generations backK950264 MaglifeOdam · 1996
- 8 generations backK023195 Maglife C/Maglife C PlusSchiller Medical S.A. · 2003
- 7 generations backK040915 Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc. · 2004
- 6 generations backK050399 Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005
- 5 generations backK053462 3160 Mri Patient Monitoring SystemInvivo Corporation · 2006 · Recalled
- 4 generations backK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
- 3 generations backK132960 BiomonitorBiotronik, Inc. · 2014
- 2 generations backK143503 BioMonitorBiotronik, Inc. · 2015
- 1 generation backK152995 BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc. · 2016
- This deviceK190548 BIOMONITOR III, Remote Assistant IIIBiotronik, Inc. · 2019
Most influential descendants
Showing 5 of 5 · See all- K200444Biomonitor III, Biomonitor IIImBiotronik, Inc. · 2020 · cites it directly4descendants
- K201865Biomonitor III, Biomonitor IIImBiotronik, Inc. · 2020 · 2 generations on3descendants
- K221856BIOMONITOR IIIm, BIOMONITOR IIIBiotronik, Inc. · 2022 · 3 generations on2descendants
- K230375Biomonitor IVBiotronik, Inc. · 2023 · 4 generations on1descendant
- K261074Biomonitor IV (471155)Biotronik, Inc. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K864889 | Omni-Trak | Invivo Research Labs, Inc. | 1987 | — |
| −9 | K950264 | Maglife | Odam | 1996 | — |
| −8 | K023195 | Maglife C/Maglife C Plus | Schiller Medical S.A. | 2003 | — |
| −7 | K040915 | Magnitude 3150M Mri Patient Monitor, Model 3150M | Invivo Research, Inc. | 2004 | — |
| −6 | K050399 | Mri Compatible Patient Monitoring System, Model 3160 | Invivo Research, Inc. | 2005 | — |
| −5 | K053462 | 3160 Mri Patient Monitoring System | Invivo Corporation | 2006 | 2 |
| −4 | K071641 | Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model… | Medtronic, Inc. | 2007 | — |
| −3 | K132960 | Biomonitor | Biotronik, Inc. | 2014 | — |
| −2 | K143503 | BioMonitor | Biotronik, Inc. | 2015 | — |
| −1 | K152995 | BioMonitor 2-AF, BioMonitor 2-S | Biotronik, Inc. | 2016 | — |
| 0 (this device) | K190548 | BIOMONITOR III, Remote Assistant III | Biotronik, Inc. | 2019 | — |
| +1 | K200444 | Biomonitor III, Biomonitor IIIm | Biotronik, Inc. | 2020 | — |
| +2 | K201865 | Biomonitor III, Biomonitor IIIm | Biotronik, Inc. | 2020 | — |
| +3 | K221856 | BIOMONITOR IIIm, BIOMONITOR III | Biotronik, Inc. | 2022 | — |
| +4 | K230375 | Biomonitor IV | Biotronik, Inc. | 2023 | — |
| +5 | 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 |
|---|---|---|
| 2020 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K152995 | BioMonitor 2-AF, BioMonitor 2-SSummary page 4…antable Cardiac (With Arrhythmia Detection) Classification Class II (21 CFR 870.1025) Product Code MXD 3. Predicate Device BIOTRONIK BioMonitor 2, K152995, cleared April 11, 2016 BIOTRONIK, Inc.… | 2016 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200444 | Biomonitor III, Biomonitor IIIm | 2020 | 4 |
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 32 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 4 of the 58 ancestors have a recall of any class.
- Of its descendants, K200444 (Biotronik, Inc., 2020) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K152995.
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. 2019, 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 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 as stated in the FDA summary.
https://510kreport.com/device/K190548 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190548: BIOMONITOR III, Remote Assistant III.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190548
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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