Nebulizer
by J & S Industries, Inc. 510(k)
Active
510(k) K770664
Overview
This device is a Nebulizer (Product Code: CAF), a medical device designed to convert liquid medication into a fine mist for inhalation therapy. It delivers aerosolized drugs directly to the respiratory tract, facilitating treatment for conditions such as asthma, chronic obstructive pulmonary disease (COPD), or cystic fibrosis.
The Nebulizer is supplied as a reusable device and is intended for use in clinical settings such as hospitals, clinics, or home care environments. It requires no specific sterility beyond standard cleaning and maintenance procedures between uses. Authorized under FDA 510K clearance (K770664), this device was reviewed by the Anesthesiology Advisory Committee in 1977 and classified as substantially equivalent to predicate devices.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK770664 | Date5 Jul 1977 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Questions
Is this nebulizer designed for single-use or can it be reused in clinical settings?
This nebulizer is explicitly designed as a reusable device, intended for use in clinical environments like hospitals, clinics, or home care. Since it’s not sterile out-of-the-box, proper cleaning and maintenance between uses are required to ensure safe, repeated use. There are no claims of single-use sterility, so it must be cleaned and disinfected according to standard protocols before each treatment session.
What types of respiratory conditions is this nebulizer intended to help treat?
While the device is not explicitly listed as an indication, it is designed to deliver aerosolized medications directly to the respiratory tract, making it suitable for conditions like asthma, COPD (chronic obstructive pulmonary disease), or cystic fibrosis. The fine mist produced allows for targeted therapy in these respiratory-related treatments, though the specific drugs or dosages would depend on the prescribed medication.
How is this nebulizer supplied, and what does the packaging include?
The nebulizer is supplied as a reusable unit without pre-packaged sterility, meaning it is not sterile out-of-the-box. It is intended for use in clinical or home settings where standard cleaning and maintenance procedures are followed between uses. The device itself is the primary component, and any accessories (e.g., masks, tubing) would typically be provided separately or as part of a complete system, though those details are not specified in the provided data.
What regulatory pathway was followed for FDA clearance, and how does that affect its use?
This nebulizer received FDA 510(k) clearance (K770664) under the Traditional Review pathway, determined to be substantially equivalent to predicate devices. The clearance was reviewed by the Anesthesiology Advisory Committee (AN) in 1977, meaning its safety and performance were evaluated against existing, legally marketed devices. Clinically, this clearance confirms the device meets FDA standards for its intended use in aerosolizing medications, but it does not imply any specific clinical indication beyond what is described in the device’s labeling.