Identifiers
- 510(k) Number
- K925927 FDA 510(k)
- FDA Product Code
- FPA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5440 FDA 510(k)
- Regulation Number
- 880.5440 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MPC-1000 Injection Cap/Plug is a medical device classified under Product Code FPA, designed as a protective closure for injection ports. It is intended to seal and secure fluid pathways on medical devices, preventing contamination and ensuring sterile access during administration or withdrawal of fluids. This device is engineered for use in general hospital settings, where maintaining sterility and integrity of infusion systems is critical.
The MPC-1000 Injection Cap/Plug is supplied as a single-use component, intended for attachment to injection ports on medical devices such as intravenous lines or dialysis systems. It is regulated under FDA 510(k) clearance (K925927) and falls under the General Hospital advisory committee classification. The device is not intended for MRI use and must be handled and stored in accordance with standard sterile medical device protocols to preserve functionality and sterility.
Frequently asked questions
What is the MPC-1000 Injection Cap/Plug used for?
The MPC-1000 Injection Cap/Plug is designed as a protective closure for injection ports on medical devices like intravenous lines or dialysis systems. Its primary purpose is to seal and secure fluid pathways, ensuring sterility during administration or withdrawal of fluids. This helps prevent contamination and maintains the integrity of infusion systems in general hospital environments.
Is the MPC-1000 Injection Cap/Plug intended for reuse?
No, the MPC-1000 Injection Cap/Plug is explicitly supplied as a single-use component. Using it more than once could compromise sterility and compromise the device’s ability to protect against contamination, posing risks to patient safety.
How should the MPC-1000 Injection Cap/Plug be stored?
The device must be stored in accordance with standard sterile medical device protocols to preserve its sterility and functionality. This typically involves keeping it in its original packaging, in a clean, dry environment, and away from direct sunlight or extreme temperatures until immediate use.
Can the MPC-1000 Injection Cap/Plug be used with MRI equipment?
No, the MPC-1000 Injection Cap/Plug is explicitly not intended for MRI use. Its design and materials are not approved or tested for compatibility with magnetic resonance imaging environments, which could pose safety risks.
What regulatory clearance does the MPC-1000 Injection Cap/Plug hold?
The MPC-1000 Injection Cap/Plug holds FDA 510(k) clearance under the classification of Product Code FPA, with a clearance number of K925927. It was determined to be substantially equivalent to a predicate device and falls under the General Hospital advisory committee classification.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MPC-1000 INJECTION CAP/PLUG (K925927) — FDA 510 (k) | Innolitics, MPC-1000 INJECTION CAP/PLUG 510(k) K925927 - FDA.report, Mpc-1000 Injection Cap/Plug - Beudamed, Molded Products Inc. | Injection Molding | Dialysis Products
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K925927 | Class II | Active |
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Manufacturer
- Manufacturer
- Molded Products, Inc.
Sources (1)
- FDA 510(k) K925927 24 fields · synced Oct 1, 2026