510(k) · Cleared
Recalled · Class II · 2022Nihon Kohden CO2 Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden Corporation · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Oct 11, 2017 as substantially equivalent to K062115 (Nihon Kohden America, Inc., 2006) and 1 other predicate after a 119-day review. Its family tree reaches back 5 generations to 1995. It has been recalled once.
- Decided
- Oct 11, 2017
- Review
- 119 days
- Class
- Class II
- Product code
- CCK
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K951127 (1995). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK951127 Hewlett-Packard Model M1026A Anesthetic Gas ModuleHewlett-Packard GmbH · 1995
- 4 generations backK965062 Siemens SC9000/SC9015 Multigas and Multigas+ ModulesSiemens Medical Solutions USA, Inc. · 1997
- 3 generations backK020046 Multigas Unit, Model AG-920RANihon Kohden America, Inc. · 2002
- 2 generations backK030105 Anesthesia Monitor; Bedside Monitor, Series BSM-5130ANihon Kohden America, Inc. · 2003
- 1 generation backK062115 Carbon Dioxide Monitor, Model Olg-2800ANihon Kohden America, Inc. · 2006
- This deviceK171765 Nihon Kohden CO2 MonitorNihon Kohden Corporation · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K951127 | Hewlett-Packard Model M1026A Anesthetic Gas Module | Hewlett-Packard GmbH | 1995 | — |
| −4 | K965062 | Siemens SC9000/SC9015 Multigas and Multigas+ Modules | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −3 | K020046 | Multigas Unit, Model AG-920RA | Nihon Kohden America, Inc. | 2002 | — |
| −2 | K030105 | Anesthesia Monitor; Bedside Monitor, Series BSM-5130A | Nihon Kohden America, Inc. | 2003 | — |
| −1 | K062115 | Carbon Dioxide Monitor, Model Olg-2800A | Nihon Kohden America, Inc. | 2006 | — |
| 0 (this device) | K171765 | Nihon Kohden CO2 Monitor | Nihon Kohden Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2010 | 1 | 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? (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 |
|---|---|---|---|
| * | K062115 | Carbon Dioxide Monitor, Model Olg-2800ASummary page 4…NE Biteblock, YG-227T): Regulation: 21 CFR 868.1400 CO2 Monitor, OLG-3800A Nihon Kohden CO2 Monitor, OLG-2800A (K062115) Predicate: Reference: Nihon Kohden Bedside Monitor, BSM-6000 series (K080342) Biteblock, YG-227T… | 2006 |
| * | K093388 | Smart Capnoline GuardianSummary page 4…Nihon Kohden Bedside Monitor, BSM-6000 series (K080342) Biteblock, YG-227T Oridion/Covidien/Medtronic Smart CapnoLine Guardian (K093388) Predicate: Description: The Nihon Kohden OLG-3800A is a compact CO2 monitor with a 7-inch display and is designed so the o… | 2010 |
| † | K080342 | Nihon Kohden Bedside Monitor, Model BSM-6000S Series | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 29, 2022 | Class II | Z-0314-2025 | Process control | Due to products being shipped/distributed to customers after the products expiration date had past. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 9 ancestors has a recall of any class.
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. 2017, this device’s year, is highlighted.
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 OLG-3800A CO2 monitor is intended to monitor respiratory rate, CO2 partial pressure and EtCO2. The device is also intended to monitor pulse rate and SpO2.
The device may generate an audible and/or visible alarm when a measured physiological rate falls outside preset limits, or when a technical error is detected.
The devices are intended to be used by qualified medical personnel within a medical facility, such as hospital or clinic, on all patient populations including adult, neonate, infant, child, and adolescent subgroups.
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/K171765 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171765: Nihon Kohden CO2 Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171765
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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