510(k) · Cleared
ClearedMultinex Monitor (Modification)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datascope Corp. · CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Cleared on Sep 12, 1988 after a 41-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 59 later devices descend from it.
- Decided
- Sep 12, 1988
- Review
- 41 days
- Class
- Class II
- Product code
- CCL
- Recalls
- None
- Predicates
- 0
59 later devices descend from it, 1 citing it directly.
- This deviceK883254 Multinex Monitor (Modification)Datascope Corp. · 1988
- Descendant · cites it directly · 58 of its ownK974581 Millennia 3500 Series Monitor with Anthesthetic AgentInvivo Research, Inc. · 1998
- Descendant · 2 generations on · 56 of its ownK041918 Integrated Patient Monitoring SystemInvivo Research, Inc. · 2004
- 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
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K974581Millennia 3500 Series Monitor with Anthesthetic AgentInvivo Research, Inc. · 1998 · cites it directly58descendants
- K041918Integrated Patient Monitoring SystemInvivo Research, Inc. · 2004 · 2 generations on56descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K883254 | Multinex Monitor (Modification) | Datascope Corp. | 1988 | — |
| +1 | K974581 | Millennia 3500 Series Monitor with Anthesthetic Agent | Invivo Research, Inc. | 1998 | — |
| +2 | K041918 | Integrated Patient Monitoring System | Invivo Research, Inc. | 2004 | — |
| +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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 2 | 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 CCL? 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 CCL device
- #1 K261389 PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)score 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (59)
See all 591 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K974581 | Millennia 3500 Series Monitor with Anthesthetic Agent | 1998 | 58 |
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, K974581 (Invivo Research, Inc., 1998) has gone furthest, with 58 descendants of its own.
How does its category compare?
All CCL devicesCCL Analyzer, Gas, Oxygen, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CCL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CCL
Too few CCL 510(k)s in any year since 2007 to give a median.
Recalls per year · CCL
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CCL
2in 2025
MAUDE reports naming product code CCL, 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 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 0 | — | 1 | 2 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K883254 · printed Nov 6, 2026
Cite this page
510(k) Report. “K883254: Multinex Monitor (Modification).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K883254
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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