STAT Profile Ultra 11 Analyzer (Modification)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K954711 FDA 510(k)
- FDA Product Code
- CHL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1120 FDA 510(k)
- Regulation Number
- 862.1120 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The STAT Profile Ultra 11 Analyzer (Modification) is an Electrode Measurement Device for blood-gas analysis, measuring partial pressures of carbon dioxide (PCO₂) and oxygen (PO₂), as well as blood pH. It falls under the classification of Electrode Measurement, Blood-Gases (PCO₂, PO₂) and Blood pH and is designed for rapid, precise clinical chemistry testing in critical care settings.
This device is intended for single-use in clinical chemistry laboratories and critical care environments, adhering to FDA 510(k) clearance (K954711) under regulation 862.1120. Supplied as a reusable analyzer with disposable consumables, it operates within the Class II medical device category and requires proper calibration and maintenance as specified by the manufacturer. No MRI safety information is provided.
Frequently asked questions
What is the STAT Profile Ultra 11 Analyzer (Modification) used for?
The STAT Profile Ultra 11 Analyzer (Modification) is an electrode measurement device designed to measure partial pressures of carbon dioxide (PCO₂) and oxygen (PO₂), as well as blood pH, enabling rapid and precise blood-gas analysis in critical care settings and clinical chemistry laboratories.
Is the STAT Profile Ultra 11 Analyzer (Modification) intended for single-use or reuse?
The device is supplied as a reusable analyzer that requires disposable consumables for operation; while the analyzer itself is intended for repeated use with proper maintenance, the consumables such as electrodes and cartridges are single-use and must be replaced after each test to ensure accuracy and prevent cross-contamination.
What regulatory pathway was used for the STAT Profile Ultra 11 Analyzer (Modification)?
The device received FDA 510(k) clearance under submission K954711, classified as substantially equivalent to a predicate device, and is regulated under 21 CFR 862.1120 as a Class II medical device for electrode measurement of blood gases and pH.
What type of consumables are required for the STAT Profile Ultra 11 Analyzer (Modification) to function?
The analyzer requires disposable electrode cartridges and calibration solutions as consumables, which are single-use and must be replaced regularly according to the manufacturer’s instructions to maintain measurement accuracy and ensure reliable blood-gas and pH results.
In what environments is the STAT Profile Ultra 11 Analyzer (Modification) designed to be used?
The device is designed for use in clinical chemistry laboratories and critical care environments where rapid, precise blood-gas analysis is needed, such as in intensive care units, emergency departments, or operating rooms, supporting timely clinical decision-making.
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: Stat Profile Ultra 11 Analyzer (Modification), PDF K954711 Stat Profile Ultra 11 Analyzer (Modification), STAT PROFILE ULTRA 11 ANALYZER (MODIFICATION) 510 (k)… - FDA.report, Stat Profile® | Nova Biomedical, STAT PROFILE ULTRA 11 ANALYZER (K943643) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K954711 | Class II | Active |
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Manufacturer
- Manufacturer
- Nova Biomedical Corp.
Sources (1)
- FDA 510(k) K954711 24 fields · synced Sep 19, 2026