AutoSafe-Reflex Safety Needle, AutoSafe Advantage Safety Needle
510(k) K071567
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK071567 | Date14 Sep 2007 | 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- Withdrawn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
- FMI
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5570
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The AutoSafe-Reflex Safety Needle and AutoSafe Advantage Safety Needle are hypodermic, single-lumen needles designed with a passive safety shield mechanism. These devices are intended for use with standard luer slip and luer lock syringes to facilitate fluid injection or withdrawal. Their passive safety feature helps reduce the risk of needle-stick injuries by automatically engaging a protective shield upon needle retraction.
These needles are single-use, non-sterile devices classified under FDA regulation 880.5570 for general hospital use. They are supplied as reusable components for integration into syringe systems and require no additional sterilisation beyond standard medical practice. The devices are authorised under an FDA 510(k) clearance (K071567) with a classification as substantially equivalent to predicate devices. No MRI safety information or specific storage requirements are noted in the regulatory data.
Questions
AI-generated answers, 20 Sep 2026
Are these needles designed for reuse, or are they meant to be used only once per patient?
These needles are explicitly labeled as single-use devices. They are not intended for reuse on multiple patients, even after cleaning or reprocessing. The design and safety features are optimized for one-time use to minimize risks like needle-stick injuries and contamination.
How do the AutoSafe-Reflex and AutoSafe Advantage Safety Needles differ in terms of syringe compatibility?
Both needles are designed to work with standard luer slip and luer lock syringes, meaning they are interchangeable with widely used syringe systems. The key difference lies in their passive safety shield mechanism, which automatically engages upon needle retraction to reduce injury risk, but their compatibility with syringes remains consistent across both models.
Do these needles require any special sterilization before use, or are they provided in a sterile state?
The needles are non-sterile as supplied and are classified under FDA regulation for general hospital use. They do not require additional sterilization beyond standard medical practices (e.g., autoclaving or ethylene oxide sterilization of the syringe system they’re integrated into). Always follow facility protocols for syringe sterilization when preparing for use.
What storage conditions should be followed for these needles before use, and are there any warnings about long-term storage?
The regulatory data does not specify unique storage requirements beyond standard medical practice for reusable needle components. Since they are non-sterile and single-use, store them in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid prolonged exposure to moisture or contaminants, as this could compromise their functionality or integrity before integration into a syringe system.
Can these needles be used in an MRI environment, or are there any safety concerns related to magnetic fields?
The regulatory data does not provide MRI safety information for these needles. If used in an MRI setting, verify compatibility with the specific MRI machine and facility protocols, as metallic components (even non-ferromagnetic ones) may pose risks in strong magnetic fields. Always consult your radiology department before use in an MRI environment.