GF-310R Multigas Unit (GF-310R)— 510(k) K251641
Substantially EquivalentNihon Kohden Corporation
FDA 510(k) clearance K251641 for GF-310R Multigas Unit (GF-310R), Substantially Equivalent on 2026-08-12. Applicant: Nihon Kohden Corporation. Device class: 2.
Summary
Nihon Kohden's GF-310R Multigas Unit is filed under product code CCK, gaseous-phase carbon-dioxide gas analyzers. The record gives no model beyond GF-310R.
Class II, 21 CFR 868.1400. Anesthesiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Nihon Kohden filed from Tokyo, Japan. The decision came 440 calendar days after FDA received it (May 29, 2025 to August 12, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Nihon Kohden Corporation
- Product code
- Product code CCK
- Device class
- Class 2
- Regulation
- 21 CFR 868.1400
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tokyo, JP
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Adverse events under product code CCK
product code CCK- Death
- 3
- Malfunction
- 11,428
- Total
- 11,431
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.