510(k) · Cleared
ClearedMagnitude 3150M Mri Patient Monitor, Model 3150M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invivo Research, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Sep 22, 2004 as substantially equivalent to K974581 (Invivo Research, Inc., 1998) and 2 other predicates after a 167-day review. Its family tree reaches back 3 generations to 1987. 56 later devices descend from it.
- Decided
- Sep 22, 2004
- Review
- 167 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K864889 (1987). 14 ancestors in all, the oldest K832113 (1983). 56 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK864889 Omni-TrakInvivo Research Labs, Inc. · 1987
- 2 generations backK950264 MaglifeOdam · 1996
- 1 generation backK023195 Maglife C/Maglife C PlusSchiller Medical S.A. · 2003
- This deviceK040915 Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc. · 2004
- Descendant · cites it directly · 55 of its ownK050399 Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005
- Descendant · cites it directly · 53 of its ownK053462 3160 Mri Patient Monitoring SystemInvivo Corporation · 2006 · Recalled
- Descendant · 2 generations on · 40 of its ownK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
- Descendant · 2 generations on · 30 of its ownK071655 Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant…Medtronic, Inc. · 2007
- Descendant · 3 generations on · 28 of its ownK082475 Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX…Medtronic, Inc. · 2008
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 56 · See all- K050399Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005 · cites it directly55descendants
- K0534623160 Mri Patient Monitoring SystemInvivo Corporation · 2006 · cites it directly53descendants
- K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc. · 2007 · 2 generations on40descendants
- K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc. · 2007 · 2 generations on30descendants
- K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor…Medtronic, Inc. · 2008 · 3 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K864889 | Omni-Trak | Invivo Research Labs, Inc. | 1987 | — |
| −2 | K950264 | Maglife | Odam | 1996 | — |
| −1 | K023195 | Maglife C/Maglife C Plus | Schiller Medical S.A. | 2003 | — |
| 0 (this device) | 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 | — |
| +1 | K053462 | 3160 Mri Patient Monitoring System | Invivo Corporation | 2006 | 2 |
| +2 | K071641 | Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model… | Medtronic, Inc. | 2007 | — |
| +2 | K071655 | Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S)… | Medtronic, Inc. | 2007 | — |
| +3 | K082475 | Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac… | Medtronic, Inc. | 2008 | — |
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 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 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 | 4 | 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? (3)
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 |
|---|---|---|---|
| * | K974581 | Millennia 3500 Series Monitor with Anthesthetic AgentSummary page 1…CFR 880.2910 Class II) Predicate Devices: The predicate devices are the temperature option of the Invivo Research Millennia Vital Sign Monitor (reference 510(k) Number K974581), the Luxtron 3100 Biomedical Flouroptic Thermometer. (reference 5 10(k) Number K923189) and the Schiller Medical Maglife C (refe… | 1998 |
| * | K923189 | Luxtron Model 3100/3101/3102 MultichannelSummary page 1…tion of the Invivo Research Millennia Vital Sign Monitor (reference 510(k) Number K974581), the Luxtron 3100 Biomedical Flouroptic Thermometer. (reference 5 10(k) Number K923189) and the Schiller Medical Maglife C (reference 510(k) Number K023195). This predicate devices have the same performance specifica… | 1994 |
| * | K023195 | Maglife C/Maglife C PlusSummary page 1…10(k) Number K974581), the Luxtron 3100 Biomedical Flouroptic Thermometer. (reference 5 10(k) Number K923189) and the Schiller Medical Maglife C (reference 510(k) Number K023195). This predicate devices have the same performance specifications as the temperature option of the Magnitude TM 3150M MRI Monitor… | 2003 |
What descends from it? (56)
See all 562 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)
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 17 years and passes through 4 companies; a new generation was cleared every 6.7 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K050399 (Invivo Research, Inc., 2005) has gone furthest, with 55 descendants of its own.
- 1 other device also cites its predicate K974581.
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 Invivo Research Inc. Magnitude TM 3150M MRI Monitor is a device comprised of two separate monitors: the 3150M Monitor, which operates as the base monitor, and the 3155 Monitor, which operates as a Remote Display monitor. The 3150 and 3155 Monitors communicate through a bi-directional radio-link which operates within the MRI area. Both monitors display the patient information, and must be used together for the system to operate. A warning message is…
Read the full statement (167 words)
The Invivo Research Inc. Magnitude TM 3150M MRI Monitor is a device comprised of two separate monitors: the 3150M Monitor, which operates as the base monitor, and the 3155 Monitor, which operates as a Remote Display monitor. The 3150 and 3155 Monitors communicate through a bi-directional radio-link which operates within the MRI area. Both monitors display the patient information, and must be used together for the system to operate. A warning message is displayed if the radio-link is broken.
The Invivo Research Inc. Magnitude TM 3150M MRI Monitor is intended for general hospital or clinical use within a magnetic resonance imaging (MRI) area by medical professionals whenever it is required to monitor concentrations of anesthetic gases. The agents monitored include halothane, enflurane, isoflurane, sevoflurane and desflurane. Additionally, this monitor also monitors end-tidal carbon dioxide, nitrous oxide, oxygen gas concentrations, ECG, non-invasive blood pressure, invasive blood pressure and temperature. This device is available for sale only upon the order of a physician or other related licensed medical professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040915 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040915: Magnitude 3150M Mri Patient Monitor, Model 3150M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040915
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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