Secura Set
by Diatek, Inc. 510(k)
Active
510(k) K841859
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK841859 | Date3 Jul 1984 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- FPA
- 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 Secura Set is a Primary Administration Set (product code FPA), designed for intravenous (IV) fluid administration in hospital settings. It delivers fluids and medications directly into a patient’s venous system, ensuring controlled infusion rates for therapeutic or diagnostic purposes.
This device is supplied as a single-use, non-sterile disposable item, intended for use in general hospital environments. It was cleared under FDA 510(k) (K841859) in 1984 as substantially equivalent to a predicate device, with no explicit MRI safety or sterility requirements noted in the submission. Storage and handling follow standard sterile medical device protocols as per regulatory guidelines.
Other devices from Diatek, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of medical settings is the Secura Set intended for use in, and how does that affect its design?
The Secura Set is specifically designed for general hospital environments, as indicated by its advisory committee classification (HO). This means it is engineered for routine intravenous (IV) fluid administration in standard clinical settings where controlled infusion rates are required for therapeutic or diagnostic purposes. Its single-use, disposable nature aligns with typical hospital protocols for minimizing infection risk and ensuring patient safety in high-traffic medical areas.
Is the Secura Set sterile, and if not, how should it be handled before use?
The Secura Set is non-sterile as explicitly stated in the device description. Since it is intended for single-use in hospital settings, it must be handled according to standard sterile medical device protocols before use. This includes proper cleaning of the administration site, using sterile gloves, and adhering to aseptic techniques to prevent contamination during setup and infusion.
How is the Secura Set supplied, and what does that mean for its reuse or disposal?
The Secura Set is supplied as a single-use, disposable item, meaning it is intended for one-time use only on a single patient. This design eliminates the need for cleaning, sterilization, or reuse, reducing the risk of cross-contamination and ensuring compliance with infection control standards. After use, it should be discarded as medical waste following facility protocols.
What does the FDA clearance date and predicate device classification mean for the Secura Set’s reliability and safety?
The Secura Set was cleared under FDA 510(k) (K841859) in 1984 as substantially equivalent to a predicate device, meaning it was determined to have the same intended purpose, technological characteristics, and performance as a previously approved IV administration set. While this clearance predates modern regulatory expectations (e.g., MRI safety or advanced sterility requirements), it confirms the device met foundational safety and effectiveness standards at the time of approval for use in intravenous fluid delivery.