Boston Solution Infusion Sets
510(k) K822406
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK822406 | Date30 Sep 1982 | 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- Withdrawn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 Boston Solution Infusion Sets are intravenous infusion devices designed for the administration of fluids, medications, or solutions into a patient’s venous system. These sets are classified as infusion pumps and tubing systems, facilitating controlled delivery of therapeutic agents in clinical settings. They are engineered to ensure compatibility with various infusion therapies, including those used in general hospital care.
These infusion sets are supplied as single-use, sterile devices intended for use in hospital environments. They are regulated under FDA 510(k) clearance (K822406) and fall under the product code FPA, indicating their classification as infusion sets. Proper storage and handling are required to maintain sterility and functionality, adhering to standard medical device protocols. No additional regulatory status beyond the stated FDA clearance is implied.
Other devices from The Boston Medical Group
Questions
AI-generated answers, 1 Oct 2026
What are the Boston Solution Infusion Sets used for?
The Boston Solution Infusion Sets are designed for intravenous administration of fluids, medications, or solutions into a patient’s venous system. They are specifically engineered to facilitate controlled delivery of therapeutic agents in clinical environments, such as hospitals, ensuring compatibility with a range of infusion therapies used in general care.
Are the Boston Solution Infusion Sets single-use or reusable?
These infusion sets are supplied as single-use devices. This design ensures sterility and safety for each patient, reducing the risk of contamination or cross-infection, which is critical in clinical settings where hygiene and precision are paramount.
How should the Boston Solution Infusion Sets be stored to maintain sterility?
Proper storage is essential to preserve sterility and functionality. The sets should be stored in their original packaging, away from direct sunlight, extreme temperatures, and sources of contamination. Adhering to standard medical device storage protocols—such as keeping them in a clean, dry environment—helps maintain their integrity until use.
What regulatory clearance does the Boston Solution Infusion Set hold?
The Boston Solution Infusion Sets hold FDA 510(k) clearance under the reference number K822406. This clearance confirms that the device meets regulatory standards for safety and effectiveness as an infusion set, classified under product code FPA, and is intended for use in hospital environments.
Can these infusion sets be used with all types of intravenous therapies?
The Boston Solution Infusion Sets are engineered to be compatible with a broad range of intravenous therapies commonly used in general hospital care. However, compatibility may depend on the specific fluid or medication being administered, so it’s important to verify compatibility with the infusion set’s labeling and manufacturer guidelines before use.