510(k) · Cleared
ClearedNellcor Stat-Cap Airway CO2 Indicator, Model N-60
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nellcor, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Aug 6, 1993 after a 606-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it.
- Decided
- Aug 6, 1993
- Review
- 606 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 2 citing it directly.
- This deviceK915494 Nellcor Stat-Cap Airway CO2 Indicator, Model N-60Nellcor, Inc. · 1993
- Descendant · cites it directly · 16 of its ownK964305 Nihon Kohden Olg-100A Pocketcap Pocket CO2 Monitor with AccessoriesNihon Kohden America, Inc. · 1997
- Descendant · 2 generations on · 14 of its ownK990063 Nihon Kohden TG-901T CO2 Sensor Kit with AccessoriesNihon Kohden America, Inc. · 1999
- Descendant · 3 generations on · 13 of its ownK040875 Cap-One, Model TG-920PNihon Kohden America, Inc. · 2004
- Descendant · 4 generations on · 7 of its ownK050833 Electrode Junction Box, Model JE-921ANihon Kohden America, Inc. · 2005
- Descendant · 5 generations on · 6 of its ownK120888 PSG-1100 Sleep Diagnostic SystemNihon Kohden Corp. · 2012 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K964305Nihon Kohden Olg-100A Pocketcap Pocket CO2 Monitor with AccessoriesNihon Kohden America, Inc. · 1997 · cites it directly16descendants
- K990063Nihon Kohden TG-901T CO2 Sensor Kit with AccessoriesNihon Kohden America, Inc. · 1999 · 2 generations on14descendants
- K040875Cap-One, Model TG-920PNihon Kohden America, Inc. · 2004 · 3 generations on13descendants
- K050833Electrode Junction Box, Model JE-921ANihon Kohden America, Inc. · 2005 · 4 generations on7descendants
- K120888PSG-1100 Sleep Diagnostic SystemNihon Kohden Corp. · 2012 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915494 | Nellcor Stat-Cap Airway CO2 Indicator, Model N-60 | Nellcor, Inc. | 1993 | — |
| +1 | K964305 | Nihon Kohden Olg-100A Pocketcap Pocket CO2 Monitor with Accessories | Nihon Kohden America, Inc. | 1997 | — |
| +2 | K990063 | Nihon Kohden TG-901T CO2 Sensor Kit with Accessories | Nihon Kohden America, Inc. | 1999 | — |
| +3 | K040875 | Cap-One, Model TG-920P | Nihon Kohden America, Inc. | 2004 | — |
| +4 | K050833 | Electrode Junction Box, Model JE-921A | Nihon Kohden America, Inc. | 2005 | — |
| +5 | K120888 | PSG-1100 Sleep Diagnostic System | Nihon Kohden Corp. | 2012 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2025 | 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 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? (18)
See all 182 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, K964305 (Nihon Kohden America, Inc., 1997) has gone furthest, with 16 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 | — |
https://510kreport.com/device/K915494 · printed Nov 6, 2026
Cite this page
510(k) Report. “K915494: Nellcor Stat-Cap Airway CO2 Indicator, Model N-60.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915494
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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