BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Ca…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K201075 FDA 510(k)
- FDA Product Code
- FOZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5200 FDA 510(k)
- Regulation Number
- 880.5200 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BD Insyte Autoguard Shielded IV Catheter is a peripheral intravenous catheter designed for safe and efficient vascular access. It features a shielded needle mechanism that retracts into the catheter hub upon activation, reducing the risk of needlestick injuries. The BC and BC Pro variants incorporate blood control technology to prevent blood backflow from the hub until the initial luer connection is secured, enhancing procedural convenience.
These catheters are intended for single-use in clinical settings and are supplied sterile. They are classified under product code FOZ and have received FDA clearance via a 510(k) submission (K201075) under the General Hospital advisory committee. The devices are not MRI-safe and must be stored according to manufacturer instructions to maintain sterility and functionality. No additional regulatory status beyond the stated clearance is implied.
Frequently asked questions
What is the primary safety feature of the BD Insyte Autoguard Shielded IV Catheter that helps prevent workplace injuries during use?
The BD Insyte Autoguard Shielded IV Catheter includes a shielded needle mechanism that automatically retracts into the catheter hub once activated. This design significantly reduces the risk of needlestick injuries, which are common when handling traditional IV catheters.
Are these catheters designed for reuse, or are they intended for single-use only?
These catheters are explicitly intended for single-use in clinical settings. Reusing them could compromise sterility and patient safety, so adherence to single-use guidelines is mandatory.
What additional convenience feature is included in the BC and BC Pro variants of the BD Insyte Autoguard Shielded IV Catheter?
The BC and BC Pro variants incorporate blood control technology, which prevents blood backflow from the hub until the initial luer connection is securely made. This feature enhances procedural convenience by minimizing mess and contamination risks during setup.
How should these catheters be stored to ensure they remain sterile and functional?
The catheters must be stored according to the manufacturer’s instructions to preserve sterility and functionality. Improper storage could compromise their integrity, so following the provided guidelines is essential for maintaining readiness for use.
Can these catheters be used in an MRI environment, or are there any restrictions?
The BD Insyte Autoguard Shielded IV Catheter is not MRI-safe, meaning it should not be used in MRI environments. Patients with these catheters in place should avoid MRI procedures to prevent potential risks.
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: BD Insyte Autoguard™ BC Shielded IV Catheter with Blood Control Technology, BD Insyte Autoguard™ Shielded IV Catheter, BD Insyte Autoguard Shielded IV Catheter - Vitality Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201075 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K201075 24 fields · synced Oct 6, 2026