510(k) · Cleared
Recalled · 20113160 Mri Patient Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invivo Corporation · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Jan 18, 2006 as substantially equivalent to K050399 (Invivo Research, Inc., 2005) and 3 other predicates after a 36-day review. Its family tree reaches back 5 generations to 1987. 53 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 18, 2006
- Review
- 36 days
- Class
- Class II
- Product code
- MWI
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 5 generations to K864889 (1987). 20 ancestors in all, the oldest K832113 (1983). 53 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK864889 Omni-TrakInvivo Research Labs, Inc. · 1987
- 4 generations backK950264 MaglifeOdam · 1996
- 3 generations backK023195 Maglife C/Maglife C PlusSchiller Medical S.A. · 2003
- 2 generations backK040915 Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc. · 2004
- 1 generation backK050399 Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005
- This deviceK053462 3160 Mri Patient Monitoring SystemInvivo Corporation · 2006
- Descendant · cites it directly · 40 of its ownK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
- Descendant · cites it directly · 30 of its ownK071655 Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant…Medtronic, Inc. · 2007
- Descendant · 2 generations on · 28 of its ownK082475 Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX…Medtronic, Inc. · 2008
- Descendant · 2 generations on · 26 of its ownK103764 Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX…Medtronic, Inc. · 2011
- Descendant · 2 generations on · 23 of its ownK132649 Reveal Linq Insertable Cardiac MonitorMedtronic, Inc. · 2014 · Recalled
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc. · 2007 · cites it directly40descendants
- K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc. · 2007 · cites it directly30descendants
- K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor…Medtronic, Inc. · 2008 · 2 generations on28descendants
- K103764Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac…Medtronic, Inc. · 2011 · 2 generations on26descendants
- K132649Reveal Linq Insertable Cardiac MonitorMedtronic, Inc. · 2014 · 2 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K864889 | Omni-Trak | Invivo Research Labs, Inc. | 1987 | — |
| −4 | K950264 | Maglife | Odam | 1996 | — |
| −3 | K023195 | Maglife C/Maglife C Plus | Schiller Medical S.A. | 2003 | — |
| −2 | K040915 | Magnitude 3150M Mri Patient Monitor, Model 3150M | Invivo Research, Inc. | 2004 | — |
| −1 | K050399 | Mri Compatible Patient Monitoring System, Model 3160 | Invivo Research, Inc. | 2005 | — |
| 0 (this device) | K053462 | 3160 Mri Patient Monitoring System | Invivo Corporation | 2006 | — |
| +1 | K071641 | Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model… | Medtronic, Inc. | 2007 | — |
| +1 | K071655 | Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S)… | Medtronic, Inc. | 2007 | — |
| +2 | K082475 | Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac… | Medtronic, Inc. | 2008 | — |
| +2 | K103764 | Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable… | Medtronic, Inc. | 2011 | — |
| +2 | K132649 | Reveal Linq Insertable Cardiac Monitor | Medtronic, Inc. | 2014 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 5 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 MWI? 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K050399 | Mri Compatible Patient Monitoring System, Model 3160Summary page 2…predicate devices: Predicate Device Manufacturer 510(k) No. Date Cleared 3160 MR] Patient Invivo Research, Inc. K050399 08/26/05 Monitoring System Magnitude 3150/3155 MRI Invivo Research, Inc. K040915 09/22/04… | 2005 |
| * | K040915 | Magnitude 3150M Mri Patient Monitor, Model 3150MSummary page 2…3160 MR] Patient Invivo Research, Inc. K050399 08/26/05 Monitoring System Magnitude 3150/3155 MRI Invivo Research, Inc. K040915 09/22/04 Patient Monitoring System Integrated Patient Invivo Research, Inc. K041918 10… | 2004 |
| * | K041918 | Integrated Patient Monitoring SystemSummary page 2…ude 3150/3155 MRI Invivo Research, Inc. K040915 09/22/04 Patient Monitoring System Integrated Patient Invivo Research, Inc. K041918 10/15/04 Monitoring System Polaris 2004 Capnograph Oridion Medical Ltd K040011 05/13/04… | 2004 |
| * | K040011 | Polaris 2004 CapnographSummary page 2…Integrated Patient Invivo Research, Inc. K041918 10/15/04 Monitoring System Polaris 2004 Capnograph Oridion Medical Ltd K040011 05/13/04 INTENDED USE The 3160 MRI Patient Monitoring System is intended to monitor vital signs for patients undergoin… | 2004 |
What descends from it? (53)
See all 533 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 23, 2011 | Not classified | Z-0113-2012 | Device Design | Philips Invivo has determined that it is possible for the system's alarm limits and other device settings to spontaneously change without user intervention. This problem is associated with intermittent and frequent loss of communication… |
| Aug 13, 2008 | Not classified | Z-0971-2009 | Process design | Battery Failure: The Invivo Lithium Polymer Wireless Module Battery Part Number 9065 and the Lithium Polymer Fiber Optic Module Battery Part Number 9067 is being recalled because the battery, itself, when dropped from 3 feet/1 meter onto… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- None of the 20 ancestors has a recall.
- Of its descendants, K071641 (Medtronic, Inc., 2007) has gone furthest, with 40 descendants of its own.
- 1 other device also cites its predicate K050399.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
The 3160 MRI Patient Monitoring System is intended to monitor vital signs for patients
undergoing MRI procedures and to provide signals for synchronization for the MRI
scanner.
The 3160 MRI Patient Monitoring System is intended for use by health care
professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053462 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053462: 3160 Mri Patient Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053462
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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