Bimeco Filtered Extension Set
by Burron Medical Products, Inc.
510(k) K801605
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK801605 | Date12 Aug 1980 | 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- Withdrawn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
- FPB
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Bimeco Filtered Extension Set is a Filter, Infusion Line designed to connect intravenous administration sets to patient access devices, providing a sterile pathway for fluid administration while filtering particulate matter. Its primary function is to reduce contamination risk by trapping debris, ensuring safer infusion therapy in clinical settings.
This device is supplied as a single-use, non-sterile extension set (sterilised by the manufacturer) and is intended for use in general hospital environments. It is classified as a Class II medical device under FDA regulation 880.5440, with a product code of FPB. The set is available in various lengths and filter pore sizes (0.2, 1.2, and 5 microns) to accommodate different clinical applications, though specific dimensions are not detailed in the regulatory submission.
Other devices from Burron Medical Products, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Bimeco Filtered Extension Set in clinical settings?
The Bimeco Filtered Extension Set is designed to connect intravenous administration sets to patient access devices, creating a sterile pathway for fluid administration. Its key function is to filter out particulate matter, reducing contamination risks and ensuring safer infusion therapy by trapping debris during fluid delivery.
Is the Bimeco Filtered Extension Set intended for single-use or reusable applications?
The Bimeco Filtered Extension Set is explicitly labeled as a single-use device. While it is manufactured in a sterile state, it is not intended for reuse after a single clinical application to maintain patient safety and prevent contamination.
What filter pore sizes are available for the Bimeco Filtered Extension Set, and how do they differ?
The Bimeco Filtered Extension Set comes in three filter pore sizes: 0.2 microns, 1.2 microns, and 5 microns. These sizes cater to different clinical needs—smaller pores (like 0.2 microns) provide finer filtration for high-purity applications, while larger pores (like 5 microns) may be used where broader debris removal is sufficient. The choice depends on the specific contamination risks in the infusion process.
How should the Bimeco Filtered Extension Set be stored before use?
The device is supplied in a non-sterile state but is sterilized by the manufacturer. Storage instructions are not detailed in the regulatory data, but standard practice for single-use medical devices like this typically involves keeping it in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow manufacturer guidelines if additional storage precautions are provided.
What regulatory pathway was followed for FDA clearance of the Bimeco Filtered Extension Set?
The Bimeco Filtered Extension Set received FDA 510(k) clearance under the Traditional 510(k) Review pathway. It was determined to be substantially equivalent to a legally marketed predicate device, with a decision date of August 12, 1980. The device falls under Class II classification (product code FPB) and is intended for use in general hospital environments.