510(k) · Cleared
ClearedOmni-Trac Modification
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invivo Research, Inc. · MLD Monitor, St Segment With Alarm
Cleared on Apr 26, 1995 after a 553-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 60 later devices descend from it.
- Decided
- Apr 26, 1995
- Review
- 553 days
- Class
- Class II
- Product code
- MLD
- Recalls
- None
- Predicates
- 0
60 later devices descend from it, 1 citing it directly.
- This deviceK935020 Omni-Trac ModificationInvivo Research, Inc. · 1995
- Descendant · cites it directly · 59 of its ownK950264 MaglifeOdam · 1996
- Descendant · 2 generations on · 57 of its ownK023195 Maglife C/Maglife C PlusSchiller Medical S.A. · 2003
- Descendant · 3 generations on · 56 of its ownK040915 Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc. · 2004
- Descendant · 4 generations on · 55 of its ownK050399 Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005
- Descendant · 4 generations on · 53 of its ownK053462 3160 Mri Patient Monitoring SystemInvivo Corporation · 2006 · Recalled
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K950264MaglifeOdam · 1996 · cites it directly59descendants
- K023195Maglife C/Maglife C PlusSchiller Medical S.A. · 2003 · 2 generations on57descendants
- K040915Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc. · 2004 · 3 generations on56descendants
- K050399Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005 · 4 generations on55descendants
- K0534623160 Mri Patient Monitoring SystemInvivo Corporation · 2006 · 4 generations on53descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935020 | Omni-Trac Modification | Invivo Research, Inc. | 1995 | — |
| +1 | K950264 | Maglife | Odam | 1996 | — |
| +2 | K023195 | Maglife C/Maglife C Plus | Schiller Medical S.A. | 2003 | — |
| +3 | K040915 | Magnitude 3150M Mri Patient Monitor, Model 3150M | Invivo Research, Inc. | 2004 | — |
| +4 | K050399 | Mri Compatible Patient Monitoring System, Model 3160 | Invivo Research, Inc. | 2005 | — |
| +4 | K053462 | 3160 Mri Patient Monitoring System | Invivo Corporation | 2006 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MLD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (60)
See all 601 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K950264 | Maglife | 1996 | 59 |
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?
- Of its descendants, K950264 (Odam, 1996) has gone furthest, with 59 descendants of its own.
How does its category compare?
All MLD devicesMLD Monitor, St Segment With Alarm: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MLD
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · MLD
Too few MLD 510(k)s in any year since 2007 to give a median.
Recalls per year · MLD
No recall names MLD since 2007.
Adverse event reports per year · MLD
1in 2019
MAUDE reports naming product code MLD, 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 | 3 |
| 2008 | 1 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K935020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K935020: Omni-Trac Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935020
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026