Luer Lock Injection Cap
by Dmd Products 510(k)
Active
510(k) K911931
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK911931 | Date18 Jun 1991 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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 Luer Lock Injection Cap is a Luer Lock Connector (FDA Product Code: FPA), designed to securely seal and protect the open end of a Luer Lock connector on medical devices such as syringes, IV catheters, or infusion lines. Its threaded design ensures a tight, leak-resistant fit, preventing contamination and accidental disconnection during use.
This device is supplied sterile for single-use applications and is intended for use in clinical settings such as hospitals or outpatient care. It adheres to FDA 510(k) clearance (K911931) under the General Hospital advisory committee, ensuring compliance with regulatory standards for medical connectors. Storage requires protection from moisture and physical damage, and proper disposal follows standard biohazard protocols for single-use medical accessories.
Other devices from Dmd Products
Questions
AI-generated answers, 19 Sep 2026
What clinical scenarios is this Luer Lock Injection Cap designed to protect against during use?
This cap is designed to securely seal and protect the open end of Luer Lock connectors on devices like syringes, IV catheters, or infusion lines, preventing contamination and accidental disconnection. Its threaded design ensures a tight, leak-resistant fit, which is critical in clinical settings where maintaining sterility and preventing fluid leaks is essential, such as during patient infusion or medication administration.
Is this cap reusable, or is it meant for single-use only? How should it be handled after use?
The cap is explicitly supplied sterile for single-use only, meaning it should not be reused after opening or application. After use, it must be disposed of following standard biohazard protocols for single-use medical accessories, as contamination or reuse could compromise patient safety.
What storage conditions are required to maintain the integrity of this cap before use?
To preserve sterility and functionality, the cap must be stored in a dry environment, protected from moisture and physical damage. Exposure to humidity or rough handling could compromise its seal or sterility, so it should be kept in its original packaging until ready for use.
What types of medical devices is this cap compatible with, and how does its design ensure safety?
This cap is designed for Luer Lock connectors commonly found on syringes, IV catheters, and infusion lines. Its threaded Luer Lock mechanism ensures a secure, leak-resistant seal, preventing accidental disconnections or contamination during fluid administration or storage, which is critical for patient safety in clinical settings.