510(k) · Cleared
ClearedBiochem 8100 Anesthetic Agent Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biochem International, Inc. · CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
Cleared on Aug 31, 1989 after a 141-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
- Aug 31, 1989
- Review
- 141 days
- Class
- Class II
- Product code
- CBQ
- Recalls
- None
- Predicates
- 0
59 later devices descend from it, 1 citing it directly.
- This deviceK892646 Biochem 8100 Anesthetic Agent MonitorBiochem International, Inc. · 1989
- 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) | K892646 | Biochem 8100 Anesthetic Agent Monitor | Biochem International, Inc. | 1989 | — |
| +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 CBQ? 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 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 CBQ devicesCBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CBQ
FDA has decided no CBQ device since 2007.
Median 510(k) review, days · CBQ
Too few CBQ 510(k)s in any year since 2007 to give a median.
Recalls per year · CBQ
No recall names CBQ since 2007.
Adverse event reports per year · CBQ
1in 2022
MAUDE reports naming product code CBQ, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K892646 · printed Nov 5, 2026
Cite this page
510(k) Report. “K892646: Biochem 8100 Anesthetic Agent Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K892646
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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