nSet+ Stabilization Set [6426733] - nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]
FDA 510(k)Class II (US FDA 510(k))
by Np Medical
Identifiers
- 510(k) Number
- K251257 FDA 510(k)
- FDA Product Code
- FPA FDA 510(k)
- Models / Variants
- nSet+ Stabilization Set [6426733] FDA 510(k)nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731] FDA 510(k)nSyte Needle Free Connector (NFC) [6426727] FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5440 FDA 510(k)
- Regulation Number
- 880.5440 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The nSet+ Stabilization Set is a peripheral vascular access device designed to stabilize intravenous catheters. It includes a stabilization mechanism to reduce dislodgement risk during patient movement or activity, ensuring secure catheter placement for reliable fluid administration or medication delivery.
Supplied as a sterile, single-patient-use device, the nSet+ Stabilization Set is intended for use in hospital settings. The nSyte Needle Free Connector (NFC) variant [6426727] attaches to the set for needle-free access, reducing infection risks. The device holds an FDA 510(k) clearance under product code FPA, with decision date 2025-12-04.
Frequently asked questions
What is the primary purpose of the nSet+ Stabilization Set and how does it differ from standard IV sets?
The nSet+ Stabilization Set is specifically designed to stabilize intravenous catheters, reducing the risk of dislodgement during patient movement or activity. Unlike standard IV sets, it includes a built-in stabilization mechanism to secure the catheter in place, ensuring reliable fluid administration or medication delivery—critical for patients who may be ambulatory or engaged in activities that could otherwise compromise catheter integrity.
Are the nSet+ Stabilization Set and the nSyte Needle Free Connector (NFC) compatible with each other, and what benefit does the NFC provide?
Yes, the nSyte Needle Free Connector (NFC) is designed to attach to the nSet+ Stabilization Set variant [6426731], creating a needle-free access system. The NFC eliminates the need for repeated needle sticks during fluid administration or medication changes, significantly reducing infection risks associated with traditional needle connections while maintaining secure catheter stabilization.
How should the nSet+ Stabilization Set be stored, and is it intended for single-use or reuse?
The nSet+ Stabilization Set is supplied as a sterile, single-patient-use device, meaning it is intended for one-time use per patient only. Proper storage should follow manufacturer guidelines to maintain sterility, typically in a clean, dry environment away from direct sunlight or extreme temperatures, as reuse could compromise patient safety and device efficacy.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for healthcare providers?
The nSet+ Stabilization Set received FDA clearance through a 510(k) Traditional Review process, determined to be *substantially equivalent* to a legally marketed predicate device under product code FPA (General Hospital). This means the device meets FDA standards for safety and effectiveness as intended for peripheral vascular access stabilization, giving healthcare providers confidence in its regulatory compliance for use in hospital settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte ..., nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte ..., K251257 FDA 510 (k) - nSet+ Stabilization Set [6426733]
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251257 | Class II | Active |
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Manufacturer
- Manufacturer
- Np Medical
Sources (1)
- FDA 510(k) K251257 24 fields · synced Oct 6, 2026