VaporShield Antistick Syringe
by Vault Paragon Group, Inc. 510(k)
Active
510(k) K250847
Overview
The VaporShield Antistick Syringe is a Class II medical device designed to reduce friction and improve fluid flow during syringe use. Its antistick coating minimizes resistance, facilitating smoother administration of liquids, including medications and vaccines, while maintaining syringe integrity and usability.
This device is supplied as a single-use, non-sterile syringe with an antistick coating and is intended for use in general hospital settings. It is regulated under FDA 510(k) clearance (K250847) and falls under the medical specialty category of General Hospital. Multiple reference codes (e.g., 3012461127, 3022699058) identify compatible syringe sizes and configurations, though specific dimensions are not detailed in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK250847 | Date12 Dec 2025 | 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- Withdrawn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
- Full name
- VaporShield
- 510(k) Number
- FDA Product Code
- MEG
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5860
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Vault Paragon Group, Inc.
Questions
What is the primary purpose of the VaporShield Antistick Syringe and how does its antistick coating improve usability?
The VaporShield Antistick Syringe is designed to reduce friction and enhance fluid flow during syringe use, making it easier to administer liquids like medications and vaccines. The antistick coating minimizes resistance, ensuring smoother operation while maintaining the syringe’s integrity and usability. This is particularly useful in hospital settings where precision and ease of use are critical.
Is the VaporShield Syringe intended for single-use or reusable applications, and what does this mean for clinical workflows?
The VaporShield Antistick Syringe is explicitly supplied as a single-use device, meaning it is intended for one-time use only. This aligns with standard infection control practices in healthcare settings, reducing the risk of cross-contamination and simplifying disposal protocols. Clinicians should follow single-use guidelines to ensure patient safety and compliance with regulatory standards.
What syringe sizes and configurations are compatible with the VaporShield Antistick Syringe, and how can I verify compatibility?
The VaporShield Antistick Syringe is compatible with a wide range of syringe sizes and configurations, as indicated by multiple FEI numbers (e.g., 3012461127, 3022699058) and registration numbers. While exact dimensions aren’t detailed, these codes correspond to standard syringe types used in general hospital settings. To confirm compatibility, cross-reference the FEI numbers with your facility’s inventory or consult Vault Paragon Group’s documentation.
How should the VaporShield Antistick Syringe be stored, and are there any specific handling instructions to maintain its performance?
The VaporShield Antistick Syringe is supplied as non-sterile, so it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Since it’s single-use, it should not be reused or reprocessed. Proper storage ensures the antistick coating remains effective, but clinicians should follow standard syringe handling protocols (e.g., avoiding contamination) to maintain usability and safety before use.
What regulatory pathway was followed for the VaporShield Antistick Syringe, and how does this affect its use in clinical settings?
The VaporShield Antistick Syringe was cleared through the FDA 510(k) process (K250847) under the Traditional pathway, with a decision classification of *Substantially Equivalent* (SESE). This means it was determined to have the same intended purpose and technological characteristics as a legally marketed predicate device. Clinicians can rely on this clearance as evidence of safety and effectiveness for use in general hospital settings, though adherence to manufacturer instructions and local protocols remains essential.