510(k) · Cleared
ClearedNihon Kohden Olg-100A Pocketcap Pocket CO2 Monitor with Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden America, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Feb 19, 1997 as substantially equivalent to K915494 (Nellcor, Inc., 1993) after a 113-day review. Its family tree reaches back 1 generation to 1993. 16 later devices descend from it.
- Decided
- Feb 19, 1997
- Review
- 113 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915494 (1993). 16 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK915494 Nellcor Stat-Cap Airway CO2 Indicator, Model N-60Nellcor, Inc. · 1993
- This deviceK964305 Nihon Kohden Olg-100A Pocketcap Pocket CO2 Monitor with AccessoriesNihon Kohden America, Inc. · 1997
- Descendant · cites it directly · 14 of its ownK990063 Nihon Kohden TG-901T CO2 Sensor Kit with AccessoriesNihon Kohden America, Inc. · 1999
- Descendant · 2 generations on · 13 of its ownK040875 Cap-One, Model TG-920PNihon Kohden America, Inc. · 2004
- Descendant · 3 generations on · 7 of its ownK050833 Electrode Junction Box, Model JE-921ANihon Kohden America, Inc. · 2005
- Descendant · 4 generations on · 6 of its ownK120888 PSG-1100 Sleep Diagnostic SystemNihon Kohden Corp. · 2012 · Recalled
- Descendant · 5 generations on · 4 of its ownK142774 Polysmith Sleep SystemNeurotronics, Inc. · 2015
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K990063Nihon Kohden TG-901T CO2 Sensor Kit with AccessoriesNihon Kohden America, Inc. · 1999 · cites it directly14descendants
- K040875Cap-One, Model TG-920PNihon Kohden America, Inc. · 2004 · 2 generations on13descendants
- K050833Electrode Junction Box, Model JE-921ANihon Kohden America, Inc. · 2005 · 3 generations on7descendants
- K120888PSG-1100 Sleep Diagnostic SystemNihon Kohden Corp. · 2012 · 4 generations on6descendants
- K142774Polysmith Sleep SystemNeurotronics, Inc. · 2015 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915494 | Nellcor Stat-Cap Airway CO2 Indicator, Model N-60 | Nellcor, Inc. | 1993 | — |
| 0 (this device) | K964305 | Nihon Kohden Olg-100A Pocketcap Pocket CO2 Monitor with Accessories | Nihon Kohden America, Inc. | 1997 | — |
| +1 | K990063 | Nihon Kohden TG-901T CO2 Sensor Kit with Accessories | Nihon Kohden America, Inc. | 1999 | — |
| +2 | K040875 | Cap-One, Model TG-920P | Nihon Kohden America, Inc. | 2004 | — |
| +3 | K050833 | Electrode Junction Box, Model JE-921A | Nihon Kohden America, Inc. | 2005 | — |
| +4 | K120888 | PSG-1100 Sleep Diagnostic System | Nihon Kohden Corp. | 2012 | 1 |
| +5 | K142774 | Polysmith Sleep System | Neurotronics, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 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), 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.
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? (1)
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 |
|---|---|---|---|
| * | K915494 | Nellcor Stat-Cap Airway CO2 Indicator, Model N-60Summary page 1…00A PocketCap Pocket CO, Monitor include CO, Analyzer, CO; Monitor and CO; Indicator. The predicate device is the Nellcor N-60 Stat-Cap Airway CO: Indicator per 510(k) #K915494, commercial distribution certification dated August 6, 1993. The Nihon Kohden PocketCap Pocket CO, Monitor, model number OLG-110… | 1993 |
What descends from it? (16)
See all 162 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?
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 Nihon Kohden PocketCap Pocket CO, Monitor, model number OLG-1100A, is intended for medical purposes to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status. The device is intended as an indicator of patient carbon dioxide concentration during expiration and is not intended as the sole basis for medical diagnosis. The device will be available for use only by medical personnel within a…
Read the full statement (136 words)
The Nihon Kohden PocketCap Pocket CO, Monitor, model number OLG-1100A, is intended for medical purposes to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status. The device is intended as an indicator of patient carbon dioxide concentration during expiration and is not intended as the sole basis for medical diagnosis. The device will be available for use only by medical personnel within a hospital or other medical facility, at a remote site, or during transport from a remote site to a hospital or other medical facility. This device is not recommended for patients with low tidal volume such as patients younger than three (3) years of age or weighing less 22 pounds or patients with a respiration rate greater than or equal to 60 breaths per minute.
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/K964305 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964305: Nihon Kohden Olg-100A Pocketcap Pocket CO2 Monitor with Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964305
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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