Aerotee, Model #1001
510(k) K982408
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK982408 | Date14 Sep 1998 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CAF
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5630
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Aerotee, Model #1001 is a Nebulizer (Direct Patient Interface) designed to deliver aerosolized medication directly to a patient’s airway. It converts liquid medication into a fine mist, facilitating efficient inhalation therapy for respiratory support or anesthesia administration. This device is classified under product code CAF and is intended for use in clinical settings requiring precise aerosol delivery.
The Aerotee, Model #1001 is supplied as a single-use or reusable device (as specified in its intended use) and is regulated under FDA 510(k) clearance (K982408) with a Traditional review process. It falls under FDA Class II – Special Controls and is authorized for use in anesthesiology applications. Storage and handling instructions are detailed in the manufacturer’s documentation, though no specific sterility or MRI safety information is provided in the available data.
Other devices from Piper Medical Products
Questions
AI-generated answers, 1 Oct 2026
What is the Aerotee 1001 nebulizer designed for?
The Aerotee 1001 is a nebulizer designed for direct patient interface use, converting liquid medication into a fine mist to facilitate efficient inhalation therapy. It is specifically intended for clinical settings requiring precise aerosol delivery, including applications in anesthesiology where controlled medication administration is critical.
Is the Aerotee 1001 available as single-use or reusable?
The Aerotee 1001 can be supplied as either single-use or reusable, depending on the intended clinical application and usage guidelines outlined by the manufacturer. The decision between single-use and reusable depends on factors like infection control protocols, patient care workflows, and regulatory compliance requirements in the facility.
What regulatory pathway does the Aerotee 1001 follow?
The Aerotee 1001 is authorized under the FDA’s 510(k) clearance process, specifically with clearance number K982408. It was granted under a Traditional review by the Anesthesiology Advisory Committee and is classified as FDA Class II with Special Controls. This pathway ensures it meets established safety and performance standards for direct patient interface nebulizers.
What are the key specifications for the Aerotee 1001?
The Aerotee 1001 is classified under FDA product code CAF and is determined to be substantially equivalent to a predicate device. It was reviewed by the Anesthesiology Advisory Committee (AN) and is intended for use in clinical settings where precise aerosol delivery is required, such as during anesthesia administration.
Are there any specific storage or handling instructions provided for the Aerotee 1001?
The manufacturer provides detailed storage and handling instructions in the accompanying documentation for the Aerotee 1001. While these guidelines are essential for maintaining device performance and ensuring patient safety, the provided data does not specify sterility requirements or MRI safety information. Always refer to the manufacturer’s instructions for proper use and maintenance.