510(k) · Cleared
ClearedBioMonitor 2-AF, BioMonitor 2-S
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 Mar 31, 2017 as substantially equivalent to K152995 (Biotronik, Inc., 2016) after a 29-day review. Its family tree reaches back 10 generations to 1987.
- Decided
- Mar 31, 2017
- Review
- 29 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). No later device cites it as a predicate yet.
- 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 deviceK170628 BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc. · 2017
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 deviceK170628 BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc. · 2017
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) | K170628 | BioMonitor 2-AF, BioMonitor 2-S | Biotronik, Inc. | 2017 | — |
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 |
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…alarm) Classification Class II (21 CFR 870.1025) Product Code MXD 3. Predicate Devices x BIOTRONIK BioMonitor 2 (K152995, cleared April 11, 2016) 4. Device Description The BioMonitor 2 senses subcutaneous electrocardiograms (SECG) using two integrat… | 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 30 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 58 ancestors have a recall of any class.
- 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. 2017, 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 2 is indicated to detect the following cardiac arrhythmias:
• Atrial fibrillation,
• Bradycardia,
• Sudden rate drop,
• High ventricular rate (HVR),
• Asystole.
The BioMonitor 2 is indicated for:
• 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/K170628 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170628: BioMonitor 2-AF, BioMonitor 2-S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170628
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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