Tri-Med 610 Capnostat Gas Analyzer
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K843285 FDA 510(k)
- FDA Product Code
- CCK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.1400 FDA 510(k)
- Regulation Number
- 868.1400 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Tri-Med 610 Capnostat Gas Analyzer is a medical device classified under product code CCK, designed for the analysis of respiratory gases in clinical settings. It measures and monitors exhaled gas concentrations, primarily carbon dioxide (capnography), to assess ventilation and respiratory function during anesthesia and critical care procedures. This device aids in ensuring patient safety by providing real-time feedback on respiratory parameters, which is critical in perioperative and intensive care environments.
The Tri-Med 610 Capnostat Gas Analyzer is intended for use in hospital operating rooms, intensive care units, and emergency departments. Supplied as a reusable device, it requires proper calibration and maintenance to ensure accurate readings. The device was cleared by the FDA under 510(k) submission K843285, with a decision date of November 13, 1984, and falls under the Anesthesiology advisory committee classification. No specific sterility or MRI safety information is provided in the regulatory data.
Frequently asked questions
What is the Tri-Med 610 Capnostat Gas Analyzer used for?
The Tri-Med 610 Capnostat Gas Analyzer is designed for analyzing respiratory gases, specifically measuring exhaled carbon dioxide (capnography) to evaluate ventilation and respiratory function. It is primarily used in clinical settings like operating rooms, intensive care units, and emergency departments to provide real-time feedback on a patient’s breathing during anesthesia and critical care procedures. This helps clinicians ensure patient safety by continuously monitoring respiratory parameters.
Is the Tri-Med 610 Capnostat Gas Analyzer a single-use or reusable device?
The Tri-Med 610 Capnostat Gas Analyzer is a reusable device. Since it is intended for repeated use in clinical environments, proper calibration and maintenance are required to ensure accurate and reliable performance over time. This design allows healthcare facilities to maintain consistent monitoring capabilities without the need for disposable units.
Does the Tri-Med 610 Capnostat Gas Analyzer require sterilization?
The regulatory data for the Tri-Med 610 Capnostat Gas Analyzer does not specify any sterility requirements. As a reusable device, it should be cleaned and maintained according to manufacturer guidelines to prevent contamination and ensure proper functionality. However, since it is not intended for invasive procedures, sterilization is not a standard part of its use.
What types of clinical environments is the Tri-Med 610 Capnostat Gas Analyzer intended for?
The Tri-Med 610 Capnostat Gas Analyzer is specifically intended for use in hospital settings where real-time respiratory monitoring is critical. This includes operating rooms during surgical procedures, intensive care units for patients requiring continuous ventilation support, and emergency departments where rapid assessment of respiratory function is necessary. Its design supports environments where patient safety depends on accurate capnography readings.
How was the Tri-Med 610 Capnostat Gas Analyzer cleared for use?
The Tri-Med 610 Capnostat Gas Analyzer was cleared by the FDA under a traditional 510(k) submission (K843285) with a decision date of November 13, 1984. The clearance was granted under the Anesthesiology advisory committee classification, indicating its primary use in monitoring respiratory parameters during anesthesia and critical care. The device was determined to be substantially equivalent to a predicate device already on the market.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Tri-med 610 Capnostat Gas Analyzer - Fda K843285, TRI-MED 610 CAPNOSTAT GAS ANALYZER - Innolitics, TRI-MED 610 CAPNOSTAT GAS ANALYZER - Innolitics, Tri-Med, Inc. FDA 510 (k) Products (1977-2004)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K843285 | Class II | Active |
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Manufacturer
- Manufacturer
- Tri-Med, Inc.
Sources (1)
- FDA 510(k) K843285 24 fields · synced Oct 1, 2026