AMSafe Sure-Lok Needle-Free Connector
510(k) K173665
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK173665 | Date5 Sep 2018 | 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- Withdrawn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, 19 Sep 2026
The AMSafe Sure-Lok Needle-Free Connector is a Set, Administration, Intravascular device (product code FPA) designed to facilitate safe, needle-free connections in intravenous administration systems. It employs a swabbable, transparent housing and a tight septum seal to prevent bacterial contamination and reduce infection risks during fluid transfer.
This connector is supplied sterile, non-pyrogenic, DEHP-free, and latex-free, with an MRI-friendly design and a smooth surface for easy disinfection. It is intended for reusable use beyond 24 hours and is classified as Class II under Special Controls. Authorized by FDA 510(k) clearance (K173665), it is intended for use in general hospital settings.
Other devices from Amsino International, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of intravenous systems can the AMSafe Sure-Lok Needle-Free Connector be used with, and how does it help reduce infection risks?
The AMSafe Sure-Lok is designed for use in intravenous administration systems, specifically as a Set, Administration, Intravascular device (product code FPA). It features a swabbable, transparent housing and a tight septum seal, which allow for safe, needle-free connections while minimizing bacterial contamination. This design helps reduce infection risks during fluid transfer by providing a sterile barrier that can be disinfected with swabs.
Is the AMSafe Sure-Lok Needle-Free Connector reusable, and if so, how long can it be used for?
Yes, the AMSafe Sure-Lok is intended for reusable use beyond 24 hours, making it suitable for extended hospital stays or repeated administrations. Its smooth surface and easy-to-clean design support repeated disinfection cycles, though proper maintenance and adherence to infection control protocols are essential for safe reuse.
What materials are used in the AMSafe Sure-Lok, and does it have any special compatibility features?
The connector is sterile, non-pyrogenic, DEHP-free, and latex-free, ensuring compatibility with patients who may have sensitivities to these substances. It also features an MRI-friendly design, meaning it can be safely used in magnetic resonance imaging environments without interference or safety concerns.
How is the AMSafe Sure-Lok packaged, and what storage considerations should be kept in mind?
The device is supplied sterile, which means it is pre-packaged in a sterile barrier system to maintain cleanliness until first use. Since it is reusable, storage should follow standard hospital protocols for reusable medical devices—keeping it in a clean, dry environment, protected from contamination, and ensuring proper disinfection before reuse.
What regulatory pathway was followed for FDA clearance, and what does this mean for hospitals?
The AMSafe Sure-Lok received FDA 510(k) clearance (K173665) under the Traditional review pathway, determined to be Substantially Equivalent (SESE) to a predicate device. This means it meets FDA standards for safety and effectiveness as a Class II device under Special Controls, intended for use in general hospital settings. Hospitals can rely on this clearance as evidence of regulatory compliance for safe implementation.