510(k) · Cleared
ClearedMaglife
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Odam · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Sep 27, 1996 as substantially equivalent to K864889 (Invivo Research Labs, Inc., 1987) and 1 other predicate after a 613-day review. Its family tree reaches back 1 generation to 1987. 59 later devices descend from it.
- Decided
- Sep 27, 1996
- Review
- 613 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K864889 (1987). 2 ancestors in all. 59 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK864889 Omni-TrakInvivo Research Labs, Inc. · 1987
- This deviceK950264 MaglifeOdam · 1996
- Descendant · cites it directly · 57 of its ownK023195 Maglife C/Maglife C PlusSchiller Medical S.A. · 2003
- Descendant · 2 generations on · 56 of its ownK040915 Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc. · 2004
- Descendant · 3 generations on · 55 of its ownK050399 Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005
- Descendant · 3 generations on · 53 of its ownK053462 3160 Mri Patient Monitoring SystemInvivo Corporation · 2006 · Recalled
- Descendant · 4 generations on · 40 of its ownK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K023195Maglife C/Maglife C PlusSchiller Medical S.A. · 2003 · cites it directly57descendants
- K040915Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc. · 2004 · 2 generations on56descendants
- K050399Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005 · 3 generations on55descendants
- K0534623160 Mri Patient Monitoring SystemInvivo Corporation · 2006 · 3 generations on53descendants
- K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc. · 2007 · 4 generations on40descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K864889 | Omni-Trak | Invivo Research Labs, Inc. | 1987 | — |
| 0 (this device) | K950264 | Maglife | Odam | 1996 | — |
| +1 | K023195 | Maglife C/Maglife C Plus | Schiller Medical S.A. | 2003 | — |
| +2 | K040915 | Magnitude 3150M Mri Patient Monitor, Model 3150M | Invivo Research, Inc. | 2004 | — |
| +3 | K050399 | Mri Compatible Patient Monitoring System, Model 3160 | Invivo Research, Inc. | 2005 | — |
| +3 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 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 MHX? 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 MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K864889 | Omni-TrakSummary page 1…legally marketed device to which equivalence is being claimed : * OMNI TRAK 3100 MRI In vivo Research Inc — 12601 Research Parkway ORLANDO FL 32826 USA 510(k) numbers : K864889 - K935020 5. Device Description The MAGLIFE® MRI-Compatible Vital Signs Monitor is a complete patient monitoring system designe… | 1987 |
| * | K935020 | Omni-Trac Modification Cleared while this submission was under review Summary page 1…rketed device to which equivalence is being claimed : * OMNI TRAK 3100 MRI In vivo Research Inc — 12601 Research Parkway ORLANDO FL 32826 USA 510(k) numbers : K864889 - K935020 5. Device Description The MAGLIFE® MRI-Compatible Vital Signs Monitor is a complete patient monitoring system designed to be in… | 1995 |
What descends from it? (59)
See all 592 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?
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, 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 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
The MAGLIFE® is a device for monitoring the vital signs of patients who are undergoing a Magnetic Resonance Imaging examination. This device is designed for this special environment where ordinary patient monitoring equipment cannot be used for the following reasons : The magnetic and electric fields present in the vicinity of the MRI can interfere with the proper operation of ordinary monitors. The presence of ferromagnetic materials in an ordinary…
Read the full statement (121 words)
The MAGLIFE® is a device for monitoring the vital signs of patients who are undergoing a Magnetic Resonance Imaging examination. This device is designed for this special environment where ordinary patient monitoring equipment cannot be used for the following reasons :
The magnetic and electric fields present in the vicinity of the MRI can interfere with the proper operation of ordinary monitors.
The presence of ferromagnetic materials in an ordinary monitor may influence the homogeneity of the magnetic field and thereby degrade the quality of the image acquired.
Some magnetic materials can become dangerous projectiles in the presence of large magnetic fields.
The indications for use are identical to the indications for vital signs monitoring of patients not undergoing MRI examinations.
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/K950264 · printed Nov 4, 2026
Cite this page
510(k) Report. “K950264: Maglife.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K950264
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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