Protector Syringe Safety Cap System
510(k) K922158
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK922158 | Date21 Jul 1992 | 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- Withdrawn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, 1 Oct 2026
The Protector Syringe Safety Cap System is a syringe safety device designed to reduce needle-stick injuries by covering and securing the needle after use. It is classified as a syringe safety cap and functions as a passive or active barrier to prevent accidental punctures, enhancing occupational safety for healthcare professionals. The system is intended for use with standard intramuscular syringes, providing a simple yet effective means of needle protection during and after administration.
This device is supplied as a single-use, non-sterile component intended for attachment to compatible syringes. It is regulated under FDA 510(k) clearance (K922158) and falls under the General Hospital advisory committee classification. The system is not MRI-safe, and no specific storage requirements are noted beyond standard medical device handling. No additional regulatory approvals beyond the 510(k) clearance are referenced in the available data.
Other devices from Injectimed, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Protector Syringe Safety Cap System designed to do?
The Protector Syringe Safety Cap System is engineered to minimize needle-stick injuries by covering and securing the needle after use. It acts as a physical barrier—either passive or active—to prevent accidental punctures, significantly improving occupational safety for healthcare professionals during and after syringe administration. This is particularly useful when handling standard intramuscular syringes, where accidental needle exposure poses a risk.
How is the Protector Syringe Safety Cap System supplied, and is it sterile?
The system is supplied as a single-use component and is explicitly labeled as non-sterile. It is intended for attachment to compatible intramuscular syringes, providing a straightforward solution for needle protection. The non-sterile designation means it should not be used in sterile procedures unless further sterilized by the user, though this is not recommended per the manufacturer’s intended use.
Can the Protector Syringe Safety Cap System be reused, or is it meant for one-time use?
The device is explicitly designed for single-use only. Reusing it could compromise its protective function, increase the risk of contamination, or damage the cap’s integrity, potentially exposing users to needle-stick hazards. Single-use aligns with best practices for syringe safety to ensure reliability and reduce infection risks.
Are there specific storage instructions for the Protector Syringe Safety Cap System?
No specialized storage requirements are documented beyond standard medical device handling. This means it should be stored in a clean, dry environment, protected from physical damage or contamination, and kept at room temperature unless otherwise specified by local facility protocols. Avoid exposure to extreme temperatures or moisture, as these could degrade the material or functionality of the cap.
Is the Protector Syringe Safety Cap System compatible with all syringe types, or only specific models?
The system is intended for use with standard intramuscular syringes, though compatibility may depend on the specific syringe’s design and dimensions. While not explicitly limited to a single model, users should verify fitment with their syringe brand and gauge before attachment. Injectimed’s documentation does not list exclusions, but improper sizing could impair the cap’s ability to secure the needle effectively.