Identifiers
- 510(k) Number
- K890058 FDA 510(k)
- FDA Product Code
- CCL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.1720 FDA 510(k)
- Regulation Number
- 868.1720 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Uniox Oxygen Alarm is a gaseous-phase oxygen analyzer designed to monitor oxygen levels in medical environments. Classified as an analyzer for gas, oxygen detection, this device provides real-time alerts to ensure patient safety by maintaining appropriate oxygen concentrations during procedures, particularly in anesthesiology settings.
This device is intended for use in clinical settings where precise oxygen monitoring is critical, such as operating rooms and anesthesia workstations. Supplied as a reusable medical device, it adheres to regulatory standards under FDA 510(k) clearance (K890058) and falls under classification CCL (Analyzer, Gas, Oxygen, Gaseous-phase). No specific sterility or MRI safety information is provided in the data, and its use is governed by the regulatory framework outlined in 868.1720.
Frequently asked questions
What is the Uniox Oxygen Alarm used for?
The Uniox Oxygen Alarm is designed to monitor gaseous-phase oxygen levels in medical environments, particularly in anesthesiology settings. It provides real-time alerts to help maintain safe and accurate oxygen concentrations during surgical procedures or anesthesia administration, reducing the risk of hypoxia or hyperoxia for patients.
Is the Uniox Oxygen Alarm a single-use or reusable device?
The Uniox Oxygen Alarm is supplied as a reusable medical device. It is intended for repeated use in clinical settings like operating rooms and anesthesia workstations, provided it is properly maintained and calibrated according to manufacturer guidelines.
What regulatory framework applies to the Uniox Oxygen Alarm?
The Uniox Oxygen Alarm is governed by FDA 510(k) clearance under the classification CCL (Analyzer, Gas, Oxygen, Gaseous-phase). It was originally submitted to the FDA in 1989 and received clearance as substantially equivalent to a predicate device, with the advisory committee being Anesthesiology (AN). The device adheres to regulatory standards outlined in 868.1720.
Does the Uniox Oxygen Alarm require any special storage conditions?
The device data does not specify special storage conditions such as temperature or humidity requirements. However, as a reusable medical device, it should be stored in a clean, dry environment, protected from physical damage, and maintained according to the manufacturer’s instructions to ensure accurate and reliable performance.
What types of clinical settings is the Uniox Oxygen Alarm intended for?
The Uniox Oxygen Alarm is specifically intended for use in clinical settings where precise oxygen monitoring is critical, such as operating rooms and anesthesia workstations. Its real-time alert capabilities make it particularly valuable in procedures where oxygen concentration must be carefully controlled to ensure patient safety.
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: VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM - Innolitics, VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM 510(k) K890058 - fda.report, Home | Vascular Technology, Incorporated (VTI), VASCULAR TECHNOLOGY INCORPORATED FDA Filings - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K890058 | Class II | Active |
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Manufacturer
- Manufacturer
- Vascular Technology Incorporated
Sources (1)
- FDA 510(k) K890058 24 fields · synced Oct 1, 2026