510(k) · Cleared
ClearedCarbon Dioxide Monitor, Model Olg-2800A
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 Dec 27, 2006 as substantially equivalent to K030105 (Nihon Kohden America, Inc., 2003) after a 156-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Dec 27, 2006
- Review
- 156 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K951127 (1995). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK951127 Hewlett-Packard Model M1026A Anesthetic Gas ModuleHewlett-Packard GmbH · 1995
- 3 generations backK965062 Siemens SC9000/SC9015 Multigas and Multigas+ ModulesSiemens Medical Solutions USA, Inc. · 1997
- 2 generations backK020046 Multigas Unit, Model AG-920RANihon Kohden America, Inc. · 2002
- 1 generation backK030105 Anesthesia Monitor; Bedside Monitor, Series BSM-5130ANihon Kohden America, Inc. · 2003
- This deviceK062115 Carbon Dioxide Monitor, Model Olg-2800ANihon Kohden America, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK171765 Nihon Kohden CO2 MonitorNihon Kohden Corporation · 2017 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K171765Nihon Kohden CO2 MonitorNihon Kohden Corporation · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K951127 | Hewlett-Packard Model M1026A Anesthetic Gas Module | Hewlett-Packard GmbH | 1995 | — |
| −3 | K965062 | Siemens SC9000/SC9015 Multigas and Multigas+ Modules | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −2 | K020046 | Multigas Unit, Model AG-920RA | Nihon Kohden America, Inc. | 2002 | — |
| −1 | K030105 | Anesthesia Monitor; Bedside Monitor, Series BSM-5130A | Nihon Kohden America, Inc. | 2003 | — |
| 0 (this device) | K062115 | Carbon Dioxide Monitor, Model Olg-2800A | Nihon Kohden America, Inc. | 2006 | — |
| +1 | K171765 | Nihon Kohden CO2 Monitor | Nihon Kohden Corporation | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (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 |
|---|---|---|---|
| * | K030105 | Anesthesia Monitor; Bedside Monitor, Series BSM-5130ASummary page 1…* The classification name: Monitor, breathing frequency * Legally Marketed Predicate: Nihon Kohden BMS-5 13 OA Series Bedside Monitor per 5 10(k)# K030105. Description and Intended Use: The OLG-2800A is a portable monitor that monitors respiration status of patients at a medical fa… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171765 | Nihon Kohden CO2 Monitor | 2017 | 0 |
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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K171765 (Nihon Kohden Corporation, 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K030105.
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 OLG-2800A is a portable monitor that measures respiration status of patients at a medical facility setting. The device is used with commercially available sensors for intubated and non-intubated patients. The device displays waveforms and numeric data of monitored parameters, such as: CO 2, EtCO 2, respiratory rate, and trendgraphs. The device may generate an audible and/or visual alarm when a measured parameter falls outside preset limits. The…
Read the full statement (117 words)
The OLG-2800A is a portable monitor that measures respiration status of patients at a medical facility setting. The device is used with commercially available sensors for intubated and non-intubated patients. The device displays waveforms and numeric data of monitored parameters, such as: CO 2, EtCO 2, respiratory rate, and trendgraphs. The device may generate an audible and/or visual alarm when a measured parameter falls outside preset limits.
The device LED display shows ETCO 2 value and respiration rate and the LCD display shows CO 2 waveforms, and alarm settings. The device is AC and/or battery operated. This device will be available for use by medical personnel on all patient populations depending on the CO 2 sensor kit.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062115: Carbon Dioxide Monitor, Model Olg-2800A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062115
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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