510(k) · Cleared
Recalled · 2010Capnocheck II, Model 8400
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 Jun 9, 1999 as substantially equivalent to K941982 (Bci, Inc., 1994) and 2 other predicates after a 70-day review. Its family tree reaches back 1 generation to 1987. 1 of the 4 devices in its family, counting itself, has a Class I recall. It has been recalled once.
- Decided
- Jun 9, 1999
- Review
- 70 days
- Class
- Class II
- Product code
- CCK
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K873856 (1987). 3 ancestors in all. No later device cites it as a predicate yet. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK873856 Biochem 9090 Capnograph/SAO2Biochem International, Inc. · 1987
- This deviceK991086 Capnocheck II, Model 8400Bci Intl., Inc. · 1999
Class I recalls in this family
- K970209 Capnocheck Plusdirect predicate · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K873856 | Biochem 9090 Capnograph/SAO2 | Biochem International, Inc. | 1987 | — |
| 0 (this device) | K991086 | Capnocheck II, Model 8400 | Bci Intl., Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 1 |
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.
1 device in this family has 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? (3)
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 |
|---|---|---|---|
| * | K941982 | CapnocheckSummary page 1…26, 1999 Proprietary Name: BCI Capnocheck® II Common/Classification Name: Capnograph with pulse oximeter and optional printer. Predicate Devices: BCI 8200 Capnometer (K941982) BCI 9000 Capnograph (K873856) BCI 9004 Capnograph (K970209) New Device Description: The BCI 8400 Capnocheck Il monitor perfor… | 1994 |
| * | K873856 | Biochem 9090 Capnograph/SAO2Summary page 1…Capnocheck® II Common/Classification Name: Capnograph with pulse oximeter and optional printer. Predicate Devices: BCI 8200 Capnometer (K941982) BCI 9000 Capnograph (K873856) BCI 9004 Capnograph (K970209) New Device Description: The BCI 8400 Capnocheck Il monitor performs capnography and pulse oximet… | 1987 |
| * | K970209 | Capnocheck PlusSummary page 1…fication Name: Capnograph with pulse oximeter and optional printer. Predicate Devices: BCI 8200 Capnometer (K941982) BCI 9000 Capnograph (K873856) BCI 9004 Capnograph (K970209) New Device Description: The BCI 8400 Capnocheck Il monitor performs capnography and pulse oximetry using the same technology a… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 15, 2010 | Not classified | Z-0920-2010 | Nonconforming Material/Component | Smiths Medical is conducting a voluntary recall of a limited number of medical device AC power cords, manufactured by Electri-Cord Manufacturing Co., for use with BCI 3180 Pulse Oximeter(Human), 9200 Advisor Vital Signs Monitor(Human or… |
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.
- K970209Capnocheck PlusBci Intl., Inc. · 1997 · Direct predicate · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- 2 of the 3 ancestors have a recall of any class; 1 has a Class I recall.
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 8400 Capnocheck II is a low cost CO, monitor with pulse oximeter and optional external printer. It 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 ground transport, EMS (Emergency Medical Services) and anesthesia. The capnography parameter provides end tidal CO, (ETCO,)…
Read the full statement (139 words)
The 8400 Capnocheck II is a low cost CO, monitor with pulse oximeter and optional external printer. It 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 ground transport, EMS (Emergency Medical Services) and anesthesia. The capnography parameter provides end tidal CO, (ETCO,), inspired CO; (inCO,), and respiration rate measurements on all patients from pediatric to adult. The oximetry parameter works with all BCI oximetry sensors, providing %SpO, and pulse rate on all patients from pediatric to adult. The 8400 Capnocheck I permits continuous patient monitoring with adjustable alarm limits as well as visual and auditory alarm signals. It is not intended nor designed to be used as an apnea monitor.
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/K991086 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991086: Capnocheck II, Model 8400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991086
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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