Mucus Aspirator
by Ovutime, Inc. 510(k)
Active
510(k) K781917
Overview
The Mucus Aspirator is a syringe-type device classified under Syringe, Piston, designed for the aspiration of mucus or fluid samples. It functions as a manual suction tool to collect and remove viscous secretions from anatomical sites, aiding in diagnostic or procedural applications.
This device is supplied as a single-use, non-sterile instrument (unless sterilized by the user) and is regulated under FDA 510(k) clearance (K781917) with a Substantially Equivalent determination. It falls under Regulation 880.5860 and is intended for use in general hospital settings, with no third-party review required. Storage and handling must comply with standard medical device protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781917 | Date4 Dec 1978 | 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- Withdrawn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
- FMF
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5860
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Questions
Is the Mucus Aspirator designed for single-use only, and if so, how should it be handled if reuse is considered?
Yes, the Mucus Aspirator is explicitly supplied as a single-use device. While it is non-sterile as shipped, users may choose to sterilize it before use if needed. However, due to its classification as a syringe-type device and its intended purpose for aspiration of viscous secretions, reuse is not recommended unless properly sterilized and validated for safety and efficacy, as single-use design aligns with standard medical device protocols to prevent contamination and ensure patient safety.
What types of anatomical sites is the Mucus Aspirator intended for use in, and how does its design support its function?
The Mucus Aspirator is designed for manual suction of mucus or fluid samples from anatomical sites where viscous secretions accumulate. Its syringe-type, piston-driven mechanism allows controlled aspiration, making it suitable for diagnostic or procedural applications in general hospital settings. The device’s simplicity and manual operation ensure precise collection without requiring complex equipment, though specific anatomical use depends on clinical judgment and procedural needs.
How should the Mucus Aspirator be stored, and what considerations should be taken into account to maintain its usability?
Storage of the Mucus Aspirator must follow standard medical device protocols to preserve its integrity. Since it is non-sterile unless user-sterilized, it should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Proper packaging should remain intact until use to prevent contamination. If sterilization is required before use, follow validated protocols to ensure the device remains functional and safe for its intended aspiration purpose.
What regulatory pathway does the Mucus Aspirator follow, and what does this mean for its use in clinical settings?
The Mucus Aspirator follows the FDA’s 510(k) clearance pathway, specifically with a Substantially Equivalent (SESE) determination under clearance number K781917. This means it has been deemed comparable to a legally marketed predicate device and meets FDA requirements for safety and effectiveness. Clinically, this indicates the device is approved for use in general hospital settings without additional third-party review, though adherence to manufacturer instructions and standard medical practices remains essential for proper application.