Corflo Anti-IV Enteral Feeding Extension Set, Models 20-1006AIV-LB and 20-1030AIV-LB
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K083786 FDA 510(k)
- FDA Product Code
- FPD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5980 FDA 510(k)
- Regulation Number
- 876.5980 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Corflo Anti-IV Enteral Feeding Extension Set is a feeding tube designed for enteral nutrition delivery, preventing intravenous contamination by isolating the feeding port from the intravenous line. Classified as a Tube, Feeding, it is intended to connect enteral feeding systems to patients while maintaining separation from intravenous access to reduce cross-contamination risks.
This single-use device is supplied sterile and is intended for pediatric and neonatal use only. It is regulated under FDA 510(k) clearance (K083786) and falls under the product code FPD, with a classification of Class II. The set is intended for use in clinical settings where enteral feeding and intravenous access may coexist, ensuring safe and sterile administration of nutritional solutions.
Frequently asked questions
What is the primary purpose of the Corflo Anti-IV Enteral Feeding Extension Set, and why is it designed specifically for pediatric and neonatal use?
The Corflo Anti-IV Enteral Feeding Extension Set is designed to connect enteral feeding systems to patients while physically isolating the feeding port from intravenous lines. This prevents cross-contamination between enteral and intravenous pathways, reducing the risk of accidental intravenous infusion of feeding solutions. It is specifically intended for pediatric and neonatal use because these patient populations often require both enteral nutrition and intravenous access simultaneously, making contamination risks higher in this setting.
How is the Corflo Anti-IV Enteral Feeding Extension Set supplied, and what does this mean for clinical use?
The Corflo Anti-IV Enteral Feeding Extension Set is supplied sterile and is a single-use device. This means each set is intended for one-time use only, ensuring patient safety by maintaining sterility and reducing the risk of infection from reuse. Clinicians should open the sterile packaging immediately before use and discard it after a single procedure.
Are there different sizes or models available for the Corflo Anti-IV Enteral Feeding Extension Set, and how might this affect selection?
Yes, the Corflo Anti-IV Enteral Feeding Extension Set is available in two models: 20-1006AIV-LB and 20-1030AIV-LB. While the exact differences between these models are not specified in the data, the availability of multiple models suggests they may cater to varying clinical needs, such as different feeding tube sizes or connection types. Clinicians should select the appropriate model based on compatibility with the patient’s enteral feeding system and intravenous access setup.
How should the Corflo Anti-IV Enteral Feeding Extension Set be stored, and what precautions should be taken?
Since the device is sterile and single-use, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain intact until immediately before use to preserve sterility. After opening, the set should be used promptly and discarded according to facility protocols to prevent contamination.
What regulatory pathway does the Corflo Anti-IV Enteral Feeding Extension Set follow, and what does this mean for healthcare providers?
The Corflo Anti-IV Enteral Feeding Extension Set follows the FDA 510(k) clearance pathway, specifically with clearance number K083786. This means the device has been reviewed by the FDA and deemed substantially equivalent to a legally marketed predicate device, ensuring it meets applicable safety and performance standards. For healthcare providers, this indicates the device has undergone regulatory scrutiny, but they should always follow facility-specific protocols and manufacturer instructions for proper use.
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: Corflo Anti-iv Enteral Feeding Extension Set, Models 20-1006aiv-lb and ..., CORFLO® ANTI-IV - Adult enteral feeding set by CORPAK MedSystems ..., Corflo Anti-iv Enteral Feeding Extension Set, Models 20-1006aiv-lb and ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K083786 | Class II | Active |
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Manufacturer
- Manufacturer
- Corpak Medsystems
Sources (1)
- FDA 510(k) K083786 24 fields · synced Sep 19, 2026