510(k) · Cleared
ClearedBiochem 9090 Capnograph/SAO2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biochem International, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Dec 17, 1987 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Dec 17, 1987
- Review
- 86 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK873856 Biochem 9090 Capnograph/SAO2Biochem International, Inc. · 1987
- Descendant · cites it directly · 1 of its ownK030407 Advisor, Model 9200Bci, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 0 of its ownK061931 Solaris Compatible Reusable Adult SPO2 Finger Sensors, Models…Solaris Medical Technology, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK991086 Capnocheck II, Model 8400Bci Intl., Inc. · 1999 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K030407Advisor, Model 9200Bci, Inc. · 2003 · cites it directly1descendant
- K061931Solaris Compatible Reusable Adult SPO2 Finger Sensors, Models S100A-090103 and 300103…Solaris Medical Technology, Inc. · 2007 · 2 generations on0descendants
- K991086Capnocheck II, Model 8400Bci Intl., Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K873856 | Biochem 9090 Capnograph/SAO2 | Biochem International, Inc. | 1987 | — |
| +1 | K030407 | Advisor, Model 9200 | Bci, Inc. | 2003 | 43 |
| +2 | K061931 | Solaris Compatible Reusable Adult SPO2 Finger Sensors, Models S100A-090103 and… | Solaris Medical Technology, Inc. | 2007 | — |
| +1 | K991086 | Capnocheck II, Model 8400 | Bci Intl., Inc. | 1999 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 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 CCK? 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 CCK device
- #1 K253030 Capnostream™35 Portable Respiratory Monitor…score 15.8 · 16 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? (3)
2 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?
- Of its descendants, K030407 (Bci, Inc., 2003) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CCK devicesCCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CCK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CCK
169in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CCK
1in 2022
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · CCK
1,259in 2025
MAUDE reports naming product code CCK, 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 | 5 | 56 | 0 | 7 |
| 2008 | 3 | 248 | 1 | 20 |
| 2009 | 3 | 101 | 19 | 21 |
| 2010 | 3 | 125 | 4 | 12 |
| 2011 | 2 | — | 14 | 18 |
| 2012 | 7 | 150 | 3 | 13 |
| 2013 | 4 | 132 | 2 (1) | 28 |
| 2014 | 9 | 166 | 0 | 51 |
| 2015 | 5 | 105 | 1 | 114 |
| 2016 | 2 | — | 0 | 88 |
| 2017 | 5 | 134 | 0 | 58 |
| 2018 | 6 | 296 | 5 | 63 |
| 2019 | 7 | 261 | 7 (7) | 141 |
| 2020 | 4 | 188 | 1 | 2,302 |
| 2021 | 4 | 227 | 0 | 2,272 |
| 2022 | 3 | 226 | 1 | 2,475 |
| 2023 | 4 | 555 | 0 | 1,637 |
| 2024 | 3 | 592 | 0 | 1,216 |
| 2025 | 3 | 169 | 0 | 1,259 |
| 2026 | 3 | 224 | 0 | — |
https://510kreport.com/device/K873856 · printed Nov 6, 2026
Cite this page
510(k) Report. “K873856: Biochem 9090 Capnograph/SAO2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K873856
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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