K261530 · Deka Research and Development · FPA · Jun 3, 2026 · General Hospital
Device Facts
Record ID
K261530
Device Name
iiSure Infusion Set
Applicant
Deka Research and Development
Product Code
FPA · General Hospital
Decision Date
Jun 3, 2026
Decision
SESE
Submission Type
Special
Regulation
21 CFR 880.5440
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The iiSure Infusion Set is indicated for the intravascular administration of fluids from a container to a patient's vascular system through a vascular access device.
Device Story
Intravascular administration set; delivers fluids from container to patient vascular system. Modifications include: name update, addition of 3.5-inch tubing configuration, extension of wear duration from 72 to 96 hours, shelf-life extension, and minor material changes. Used in clinical settings; operated by healthcare professionals. Device maintains fundamental scientific technology of previously cleared predicate; design controls and risk analysis confirm safety/effectiveness of modifications.
Clinical Evidence
Bench testing only. Design control activities, including risk analysis and verification/validation testing, were performed to support the modifications.
Technological Characteristics
Intravascular administration set; includes tubing and connection components. Modifications involve material changes and configuration updates (3.5-inch tubing). Sterilization and fundamental fluid delivery principles remain consistent with the predicate device.
Indications for Use
Indicated for patients requiring intravascular fluid administration via vascular access device. No specific age or gender restrictions noted.
Regulatory Classification
Identification
An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.
Special Controls
*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
Predicate Devices
iiSure Infusion Set (K261530 - original clearance)
Submission Summary (Full Text)
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
## I Background Information:
A 510(k) Number
K261530
B Applicant
Deka Research and Development
C Proprietary and Established Names
iiSure Infusion Set
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| FPA | Intravascular administration set | 880.5440 | General Hospital |
## II Review Summary:
This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.
1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for updating the device name, adding a 3.5-
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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K261530 - Page 2 of 2
inch tubing set configuration, extending the duration of use from 72 to 96 hours, extending the shelf life, and minor modifications to the materials used in the finished device.
4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.
5. A Design Control Activities Summary which includes:
a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.
The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.
