Intellifuse Administration and Intellifuse Blood Administration Sets
510(k) K192375
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK192375 | Date18 Sep 2020 | 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- Withdrawn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
The Intellifuse Administration and Intellifuse Blood Administration Sets are classified as Set, Administration, Intravascular (product code FPA). These devices are designed for the delivery of fluids, including blood, from a container to a patient’s vascular system. They incorporate tubing and connectors optimized for safe and controlled intravenous administration. The sets are engineered to minimize contamination risk and ensure compatibility with standard medical infusion practices. Their construction supports both general fluid therapy and blood transfusion applications.
These sets are supplied as sterile, single-use devices intended for use in hospital or clinical environments. They are intended for intravenous administration and must be handled under aseptic conditions. The devices are regulated under FDA 510(k) clearance (K192375) and fall under Class II – Special Controls. No additional sterilization or reprocessing is required before use. Sizes and configurations are standardized for compatibility with common intravenous administration systems.
Intellifuse Administration and Intellifuse Blood Administration Sets
Other devices from Smiths Medical Asd, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Intellifuse Blood Administration Set used for?
The Intellifuse Blood Administration Set is specifically designed for delivering blood and other fluids intravenously from a container to a patient’s vascular system. Its tubing and connectors are optimized to ensure safe, controlled administration while reducing contamination risks. This makes it suitable for blood transfusions and general fluid therapy in clinical settings.
Are the Intellifuse Administration Sets reusable or single-use?
The Intellifuse Administration and Blood Administration Sets are intended for single-use only. They are supplied sterile and must not be reprocessed or reused after initial use to maintain patient safety and prevent contamination. This aligns with standard medical practice for intravenous administration sets.
Do these sets require additional sterilization before use?
No, the Intellifuse Administration and Blood Administration Sets are supplied sterile and do not require any additional sterilization or reprocessing before use. They are pre-sterilized by the manufacturer to ensure safety and compliance with clinical standards for intravenous administration.
What sizes and configurations are available for these sets?
The Intellifuse Administration and Blood Administration Sets come in standardized sizes and configurations to ensure compatibility with common intravenous administration systems. While exact dimensions or variations are not specified, their design is optimized for seamless integration with typical hospital infusion setups, ensuring ease of use in clinical environments.
How should these sets be stored before use?
The Intellifuse sets should be stored in their original, sealed packaging under clean, dry conditions away from direct sunlight or extreme temperatures. Proper storage ensures the integrity of sterility and functionality. Always follow manufacturer guidelines for handling and storage to maintain device performance and patient safety.