Flu Admin/Waste Disp Sys/Protec Sta/Admin/Flush-N-
by Biocor, Inc.
510(k) K912861
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK912861 | Date24 Sep 1991 | 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- Withdrawn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
- FPA
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a Flu Admin/Waste Disp Sys (Fluorescent Administration and Waste Disposal System) designed for the safe administration and disposal of fluids in medical settings. It incorporates protective station components to minimize contamination risk during administration and waste handling procedures, ensuring compliance with sterile and hygienic protocols in healthcare environments.
The system is intended for use in general hospital settings and is supplied as a reusable medical device. It is classified under product code FPA and has received FDA 510(k) clearance as substantially equivalent to a predicate device. No specific sterility or MRI safety information is provided in the regulatory data, and its design does not explicitly indicate single-use or reusable status beyond the context of its submission. Storage and handling instructions are not detailed in the available records.
Other devices from Biocor, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Flu Admin/Waste Disp Sys Protective Station designed for?
This system is specifically engineered for the safe administration and disposal of fluids in medical environments, such as hospitals. Its protective station components help reduce contamination risks during both administration and waste handling, ensuring adherence to sterile and hygienic protocols. This is particularly important in general hospital settings where fluid management is critical to patient care.
Is the Flu Admin/Waste Disp Sys Protective Station reusable or single-use?
The device is classified as a reusable medical device. The regulatory submission does not specify single-use requirements, and the design aligns with reusable systems intended for repeated use in clinical settings. Proper cleaning and maintenance are essential to ensure its continued safe operation.
What type of healthcare settings is this system intended for?
This system is intended for use in general hospital settings. The FDA clearance under product code FPA and the advisory committee classification confirm its suitability for routine clinical environments where fluid administration and waste disposal are performed. It is not explicitly indicated for specialized or outpatient settings.
Are there any specific storage or handling instructions provided for this device?
The available regulatory records do not include detailed storage or handling instructions for this system. As a reusable device, it should be stored in a clean, dry environment when not in use and maintained according to manufacturer guidelines to prevent contamination and ensure functionality. Always follow Biocor’s operational protocols for optimal performance.
How is the regulatory status of this device determined?
The Flu Admin/Waste Disp Sys Protective Station received FDA 510(k) clearance, which means it was determined to be substantially equivalent to a predicate device already on the market. This clearance was granted under the traditional review pathway by the FDA’s Orthopaedic Devices Panel (HO) in 1991. The decision confirms its compliance with U.S. regulatory requirements for medical devices in its category.