510(k) · Cleared
ClearedGF-310R Multigas Unit (GF-310R)
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 Aug 12, 2026 as substantially equivalent to K110594 (Nihon Kohden Corp., 2011) after a 440-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Aug 12, 2026
- Review
- 440 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K946306 (1995). 35 ancestors in all, the oldest K844187 (1985). No later device cites it as a predicate yet.
- Root · 7 generations backK946306 Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring SystemSiemens Medical Solutions USA, Inc. · 1995
- 6 generations backK982730 SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- 5 generations backK983632 Siemens SC 8000 Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- 4 generations backK022889 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC…Siemens Medical Solutions USA, Inc. · 2002
- 3 generations backK031340 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC…Siemens Medical Solutions USA, Inc. · 2003
- 2 generations backK040188 Infinity Gammaxl and SC 6802XL with the Scio Gas ModuleDraeger Medical Systems, Inc. · 2004
- 1 generation backK110594 GF-210R Multi-Gas Module for Nohon Kohden Bedside MonitorsNihon Kohden Corp. · 2011
- This deviceK251641 GF-310R Multigas Unit (GF-310R)Nihon Kohden Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K946306 | Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −6 | K982730 | SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −5 | K983632 | Siemens SC 8000 Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −4 | K022889 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL &… | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −3 | K031340 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with… | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −2 | K040188 | Infinity Gammaxl and SC 6802XL with the Scio Gas Module | Draeger Medical Systems, Inc. | 2004 | — |
| −1 | K110594 | GF-210R Multi-Gas Module for Nohon Kohden Bedside Monitors | Nihon Kohden Corp. | 2011 | — |
| 0 (this device) | K251641 | GF-310R Multigas Unit (GF-310R) | Nihon Kohden Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K110594 | GF-210R Multi-Gas Module for Nohon Kohden Bedside MonitorsSummary page 6…Previous 510(k) Submissions: None Predicate Device: Nihon Kohden GF-210R Multigas Module (K110594) Submission Date: August 12, 2026 1. PRODUCT DESCRIPTION The GF-310R Multigas Unit is a device tha… | 2011 |
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 31 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- None of the 35 ancestors has a recall.
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. 2026, 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 GF-310R Multigas Unit is intended to measure carbon dioxide (CO2), nitrous oxide (N2O), oxygen (O2), and following anesthetic agents (Halothane, Isoflurane, Enflurane, Sevoflurane, and Desflurane) of a patient undergoing anesthesia and display the results on a Nihon Kohden bedside monitor.
The GF-310R can measure two anesthetic agents simultaneously.
The GF-310R is intended for use by qualified medical personnel within a hospital or clinical environment and is available for use on any patients as determined by the qualified medical personnel.
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/K251641 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251641: GF-310R Multigas Unit (GF-310R).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251641
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026