510(k) · Cleared
ClearedNihon Kohden Ogs-2001A Pocketcare and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden America, Inc. · DQA Oximeter
Cleared on Jan 7, 2000 as substantially equivalent to K964305 (Nihon Kohden America, Inc., 1997) and 1 other predicate after a 168-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Jan 7, 2000
- Review
- 168 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K915494 (1993). 4 ancestors in all, the oldest K914092 (1992). No later device cites it as a predicate yet.
- Root · 2 generations backK915494 Nellcor Stat-Cap Airway CO2 Indicator, Model N-60Nellcor, Inc. · 1993
- 1 generation backK964305 Nihon Kohden Olg-100A Pocketcap Pocket CO2 Monitor with AccessoriesNihon Kohden America, Inc. · 1997
- This deviceK992455 Nihon Kohden Ogs-2001A Pocketcare and AccessoriesNihon Kohden America, Inc. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K992455 | Nihon Kohden Ogs-2001A Pocketcare and Accessories | Nihon Kohden America, Inc. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1998 | 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 DQA? 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 DQA device
- #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 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 |
|---|---|---|---|
| * | K964305 | Nihon Kohden Olg-100A Pocketcap Pocket CO2 Monitor with AccessoriesSummary page 1…ide, Gaseous-phase™ per 73 CCK. The common name for the OGS-2001A device is SpO,/CO, monitor. The predicate devices are the OLG-1100A PocketCap CO, Monitor per 510(k) #K964305 commercial distribution certification dated 02/19/1997and the BSM-1101 Life Scope EC Patient Monitor per 510(k) #K973918, commerc… | 1997 |
| * | K973918 | Nihon Kohden BSM-1101 and BSM-1102 Patient Monitor and AccessoriesSummary page 1…the OLG-1100A PocketCap CO, Monitor per 510(k) #K964305 commercial distribution certification dated 02/19/1997and the BSM-1101 Life Scope EC Patient Monitor per 510(k) #K973918, commercial distribution certification dated 01/13/1998. Nihon Kohden's model number OGS-2001A is intended for medical use to me… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K964305.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, 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 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
Nihon Kohden's model number OGS-2001A is intended for medical use to measure the blood oxygen saturation (SpO,) and to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status (CO,). This product will be available for use by medical personnel within a medical facility or in a remote environment including transport. This device is not intended to be the sole basis of diagnosis. The CO, function of…
Read the full statement (127 words)
Nihon Kohden's model number OGS-2001A is intended for medical use to measure the blood oxygen saturation (SpO,) and to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status (CO,).
This product will be available for use by medical personnel within a medical facility or in a remote environment including transport. This device is not intended to be the sole basis of diagnosis.
The CO, function of the device is intended for patients three (3) years and above and is not recommended for patients with low tidal volume such as patients weighing less than 22 pounds or patients with a respiratory rate greater than 60 breaths per minute. The CO, function will be available for all other patient populations.
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/K992455 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992455: Nihon Kohden Ogs-2001A Pocketcare and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992455
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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