Ventlab 6000 Series Humidifier
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K093617 FDA 510(k)
- FDA Product Code
- BTT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5450 FDA 510(k)
- Regulation Number
- 868.5450 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ventlab 6000 Series Humidifier is a Class II medical device classified as a Humidifier, Respiratory Gas (Direct Patient Interface). It is designed to add moisture to breathing gases delivered to patients, ensuring adequate hydration of inhaled air during respiratory support.
This device is intended for use in clinical settings where supplemental oxygen or respiratory gases are administered via tubing or nasal cannulae. Supplied as a reusable device, it requires proper cleaning and maintenance between uses. The Ventlab 6000 Series complies with FDA 510(k) clearance (K093617) under regulation 868.5450, with no associated product code (PCCP) authorization. It is regulated under the Anesthesiology specialty and reviewed by the Anesthesiology Advisory Committee.
Frequently asked questions
Is the Ventlab 6000 Series Humidifier designed for single-use or reusable applications, and what maintenance is required?
The Ventlab 6000 Series Humidifier is a reusable device intended for clinical settings where supplemental oxygen or respiratory gases are administered. Since it is not single-use, proper cleaning and maintenance between uses are required to ensure safety and functionality. The manufacturer’s instructions should be followed to maintain hygiene and performance.
What clinical settings or patient interfaces is this humidifier intended for?
This device is specifically designed to add moisture to breathing gases delivered directly to patients via tubing or nasal cannulae. It is intended for use in clinical settings where respiratory support is provided, such as hospitals, operating rooms, or intensive care units.
How is the regulatory status of the Ventlab 6000 Series Humidifier determined, and which advisory committee oversees its review?
The Ventlab 6000 Series Humidifier holds FDA 510(k) clearance (K093617) under regulation 868.5450, classified as substantially equivalent to a predicate device. Its review is conducted by the Anesthesiology Advisory Committee (AN), reflecting its use in respiratory support during anesthesia and critical care procedures.
Are there multiple models or variations of the Ventlab 6000 Series Humidifier, and how can I identify the correct one for my facility?
The Ventlab 6000 Series includes multiple variations, as indicated by the extensive list of FEI numbers (e.g., 3002807293, 3008264065). These variations may correspond to different configurations, features, or compatibility with specific respiratory systems. Consulting the manufacturer’s documentation or contacting Ventlab Corp. directly will help identify the correct model for your facility’s needs.
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: VENTLAB 6000 SERIES HUMIDIFIER (K093617) — FDA 510(k) | Innolitics, PDF K093617 - Ventlab 6000 Series Humidifier, VENTLAB 6000 SERIES HUMIDIFIER 510 (k) K093617 - 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 | K093617 | Class II | Active |
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Manufacturer
- Manufacturer
- Ventlab Corp.
Sources (1)
- FDA 510(k) K093617 24 fields · synced Sep 19, 2026