510(k) · Cleared
ClearedMaglife C/Maglife C Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schiller Medical S.A. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Jun 3, 2003 as substantially equivalent to K950264 (Odam, 1996) and 2 other predicates after a 251-day review. Its family tree reaches back 2 generations to 1987. 57 later devices descend from it.
- Decided
- Jun 3, 2003
- Review
- 251 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K864889 (1987). 4 ancestors in all. 57 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK864889 Omni-TrakInvivo Research Labs, Inc. · 1987
- 1 generation backK950264 MaglifeOdam · 1996
- This deviceK023195 Maglife C/Maglife C PlusSchiller Medical S.A. · 2003
- Descendant · cites it directly · 56 of its ownK040915 Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc. · 2004
- Descendant · 2 generations on · 55 of its ownK050399 Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005
- Descendant · 2 generations on · 53 of its ownK053462 3160 Mri Patient Monitoring SystemInvivo Corporation · 2006 · Recalled
- Descendant · 3 generations on · 40 of its ownK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
- Descendant · 3 generations on · 30 of its ownK071655 Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant…Medtronic, Inc. · 2007
Showing 5 of 57 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 57 · See all- K040915Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc. · 2004 · cites it directly56descendants
- K050399Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005 · 2 generations on55descendants
- K0534623160 Mri Patient Monitoring SystemInvivo Corporation · 2006 · 2 generations on53descendants
- K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc. · 2007 · 3 generations on40descendants
- K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc. · 2007 · 3 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K864889 | Omni-Trak | Invivo Research Labs, Inc. | 1987 | — |
| −1 | K950264 | Maglife | Odam | 1996 | — |
| 0 (this device) | K023195 | Maglife C/Maglife C Plus | Schiller Medical S.A. | 2003 | — |
| +1 | K040915 | Magnitude 3150M Mri Patient Monitor, Model 3150M | Invivo Research, Inc. | 2004 | — |
| +2 | K050399 | Mri Compatible Patient Monitoring System, Model 3160 | Invivo Research, Inc. | 2005 | — |
| +2 | K053462 | 3160 Mri Patient Monitoring System | Invivo Corporation | 2006 | 2 |
| +3 | K071641 | Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model… | Medtronic, Inc. | 2007 | — |
| +3 | K071655 | Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S)… | Medtronic, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K950264 | MaglifeSummary page 1…tient physiological monitor 5. . Predicate Devices The legally marketed devices to which equivalence is being claimed are: 0 MAGLIFE, marketed by O.D.A.M. (K950264) 0 MRI-Compatible Model 9500 manufactured by Magnetic Resonance Cop. (K954120) 0 Omni Trak 3100 MRI manufactur… | 1996 |
| * | K954120 | Model 9500 MR-Compatible Multigas MonitorSummary page 1…which equivalence is being claimed are: 0 MAGLIFE, marketed by O.D.A.M. (K950264) 0 MRI-Compatible Model 9500 manufactured by Magnetic Resonance Cop. (K954120) 0 Omni Trak 3100 MRI manufactured by In Vivo Research (K864889) 0 Model 3100 LUXTRON CK Maglife C Plus (510k)ab… | 1997 |
| * | K864889 | Omni-TrakSummary page 1….D.A.M. (K950264) 0 MRI-Compatible Model 9500 manufactured by Magnetic Resonance Cop. (K954120) 0 Omni Trak 3100 MRI manufactured by In Vivo Research (K864889) 0 Model 3100 LUXTRON CK Maglife C Plus (510k)abbreviated 06/02/03 6. Device Descriptio… | 1987 |
| * | — | Model 3100 LUXTRON CK Named without a submission number |
What descends from it? (57)
See all 571 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040915 | Magnitude 3150M Mri Patient Monitor, Model 3150M | 2004 | 56 |
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 16 years and passes through 3 companies; a new generation was cleared every 9.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K040915 (Invivo Research, Inc., 2004) has gone furthest, with 56 descendants of its own.
- 1 other device also cites its predicate K950264.
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 Maglife C is a multi-parameter patient monitor which is indicated for monitoring electrocardiogram (ECG), pulse oximetry (Sp02), pulse rate, partial carbon dioxide pressure at the end of expiration (EtC02), nitrous oxide concentration ( O / 0 N 2 0 ) , partial pressure of inspired carbon dioxide (min inspired Con), respiratory rate (RR), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), concentration of gas inspired and expired (isoflurane, halothane, enflurane, desflurane, sevoflurane), and fraction of inspired oxygen (Fi02) and temperature tracking in the immediate vicinity of a Magnetic Resonance Imagers for the surveillance of patients undergoing MRI examinations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023195 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023195: Maglife C/Maglife C Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023195
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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