510(k) · Cleared
Recalled · Class I · 2013Capnocheck Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bci Intl., Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Apr 18, 1997 after an 87-day review. The FDA summary names its predicate without a number. 2 of the 285 devices in its family, counting itself, have a Class I recall. 284 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Apr 18, 1997
- Review
- 87 days
- Class
- Class II
- Product code
- CCK
- Recalls
- 1 (1 Class I)
- Predicates
- 0
284 later devices descend from it, 4 citing it directly. 2 of the 285 devices in this family, counting this one, have a Class I recall.
- This deviceK970209 Capnocheck PlusBci Intl., Inc. · 1997
- Descendant · cites it directly · 267 of its ownK984033 Atlas MonitorWelch Allyn, Inc. · 1999
- Descendant · 2 generations on · 264 of its ownK022084 Atlas Monitor, Models 200,210,220Welch Allyn, Inc. · 2002
- Descendant · 3 generations on · 250 of its ownK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- Descendant · 4 generations on · 197 of its ownK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- Descendant · 5 generations on · 170 of its ownK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
Showing 5 of 284 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K123690 CAPNOSTREAM20P with Hifi C02 Monitoring9 generations on · 2014
Most influential descendants
Showing 5 of 284 · See all- K984033Atlas MonitorWelch Allyn, Inc. · 1999 · cites it directly267descendants
- K022084Atlas Monitor, Models 200,210,220Welch Allyn, Inc. · 2002 · 2 generations on264descendants
- K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorOridion Capnography, Inc. · 2006 · 3 generations on250descendants
- K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007 · 4 generations on197descendants
- K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · 5 generations on170descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970209 | Capnocheck Plus | Bci Intl., Inc. | 1997 | — |
| +1 | K984033 | Atlas Monitor | Welch Allyn, Inc. | 1999 | — |
| +2 | K022084 | Atlas Monitor, Models 200,210,220 | Welch Allyn, Inc. | 2002 | — |
| +3 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| +4 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| +5 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 8 | 0 |
| 2010 | 10 | 0 |
| 2011 | 8 | 0 |
| 2012 | 15 | 0 |
| 2013 | 14 | 0 |
| 2014 | 19 | 1 |
| 2015 | 13 | 0 |
| 2016 | 13 | 0 |
| 2017 | 15 | 0 |
| 2018 | 16 | 0 |
| 2019 | 16 | 0 |
| 2020 | 17 | 0 |
| 2021 | 11 | 0 |
| 2022 | 24 | 0 |
| 2023 | 16 | 0 |
| 2024 | 22 | 0 |
| 2025 | 20 | 0 |
| 2026 | 16 | 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.
2 devices in this family have a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | — | BCI 9000 Capnograph-Oximeter Named without a submission number | |
| * | — | BCI 9100 Multigas Monitor Named without a submission number |
What descends from it? (284)
See all 2844 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 6, 2013 | Class I | Z-1014-2013 | Nonconforming Material/Component | In rare instances, the BCI Remote Alarm Cables (BCI Cable) are not transferring alarms when used with some remote nurse alarm systems. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd. · 2014 · 9 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K984033 (Welch Allyn, Inc., 1999) has gone furthest, with 267 descendants 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 | — |
What is it indicated for?
The 9004 may be used in the hospital or clinical environment, and during emergency land transport. It is not intended for use in the home. It is intended to be used in all critical environments, including ventilatory applications, patient transport and anesthesia environments. The oximetry option works with all BCI oximetry probes providing SpO2 and pulse rate. The patient population is defined to be pediatric to adults. The 9004 permits continuous…
Read the full statement (117 words)
The 9004 may be used in the hospital or clinical environment, and during emergency land transport. It is not intended for use in the home. It is intended to be used in all critical environments, including ventilatory applications, patient transport and anesthesia environments. The oximetry option works with all BCI oximetry probes providing SpO2 and pulse rate. The patient population is defined to be pediatric to adults.
The 9004 permits continuous patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. It is not intended or designed to be used as an apnea monitor.
The 9004 will operate accurately over an ambient temperature range of 32 to 122° F (0 to 50° C).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970209 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970209: Capnocheck Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970209
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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