Non-Kor Access Kits
by Creative Care Systems, Inc. 510(k)
Active
510(k) K852831
Overview
The Non-Kor Access Kits are classified under product code FMI as a vascular access device, specifically designed for establishing intravenous or intra-arterial access. These kits provide sterile, disposable components for secure catheter insertion and maintenance, facilitating fluid administration, blood sampling, or medication delivery in clinical settings.
Supplied as single-use, sterile kits, these devices are intended for use in general hospital environments and are regulated under FDA 510(k) clearance (K852831). The kits include all necessary components for access procedures, with no reusable parts, and must be stored in accordance with manufacturer guidelines to maintain sterility. No MRI safety information is specified, and compliance is tied to the original 1985 clearance under 21 CFR 880.5570.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESD | NumberK852831 | Date19 Sep 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- FMI
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5570
- Advisory Committee
- General Hospital
- FDA Decision
- SESD Substantially Equivalent — Deferred
Other devices from Creative Care Systems, Inc.
Questions
What is the Non-Kor Access Kit used for?
The Non-Kor Access Kit is designed for establishing intravenous (IV) or intra-arterial access in clinical settings. It provides sterile, disposable components to facilitate catheter insertion and maintenance, enabling fluid administration, blood sampling, or medication delivery. This makes it suitable for general hospital procedures where reliable vascular access is required.
Are the Non-Kor Access Kits single-use or reusable?
The Non-Kor Access Kits are explicitly designed for single-use only. This ensures sterility and reduces the risk of contamination or infection during medical procedures. Reusing these kits is not recommended and may compromise patient safety.
What components are included in the Non-Kor Access Kit?
The kit includes all necessary sterile, disposable components required for secure catheter insertion and maintenance. This eliminates the need for reusable parts and ensures a complete, ready-to-use solution for vascular access procedures.
How should the Non-Kor Access Kits be stored to maintain sterility?
The kits must be stored in accordance with the manufacturer’s guidelines to preserve sterility. Proper storage conditions, such as keeping them in a clean, dry environment and avoiding exposure to contaminants, are critical to maintaining their integrity for clinical use.
Is there any MRI safety information provided for the Non-Kor Access Kit?
No MRI safety information is specified for the Non-Kor Access Kit. Clinicians should verify compatibility with MRI equipment if the procedure involves magnetic resonance imaging, as this information is not included in the device’s documentation.