FAST1 Intraosseous Infusion System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K080865 FDA 510(k)
- FDA Product Code
- FMI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5570 FDA 510(k)
- Regulation Number
- 880.5570 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The FAST1 Intraosseous Infusion System is a manual intraosseous device designed for establishing sternal intraosseous access in patients when standard venous access is not feasible. It provides a rapid route for administering fluids and medications directly into the bone marrow space, facilitating emergency resuscitation. This single-use device is intended for adult and adolescent patients aged 12 and older. Its primary function is to ensure timely vascular administration during critical situations, such as trauma or cardiac arrest.
The FAST1 Intraosseous Infusion System is supplied as a single-use manual device and is intended for use in emergency settings where intravenous access is unavailable. It is not classified as MRI-safe or MRI-conditional, and no specific sterility or reprocessing instructions are provided in the data. The system is authorized under an FDA 510(k) clearance (K080865) as substantially equivalent to existing devices. Storage and handling details are not specified, but it is designed for one-time use per patient.
Frequently asked questions
What is the FAST1 Intraosseous Infusion System used for?
The FAST1 Intraosseous Infusion System is designed to establish sternal intraosseous access in patients when standard venous (IV) access is not feasible. It delivers fluids and medications directly into the bone marrow space, ensuring rapid administration during critical emergencies like trauma or cardiac arrest. This is particularly useful when immediate vascular access is required to stabilize a patient’s condition.
Who is the FAST1 Intraosseous Infusion System intended for?
This device is intended for adult and adolescent patients aged 12 and older. It is not designed for pediatric patients under 12 years of age. The system is specifically engineered for emergency scenarios where traditional IV access is unavailable or impractical.
Is the FAST1 Intraosseous Infusion System single-use or reusable?
The FAST1 Intraosseous Infusion System is a single-use manual device. Each unit is intended for one-time use per patient to ensure sterility and safety. Reuse is not recommended or supported by the manufacturer.
How is the FAST1 Intraosseous Infusion System supplied?
The FAST1 Intraosseous Infusion System is supplied as a complete, ready-to-use manual device. No additional components or accessories are required for its use. The packaging ensures the device remains sterile until first use.
Can the FAST1 Intraosseous Infusion System be used with MRI?
No, the FAST1 Intraosseous Infusion System is not classified as MRI-safe or MRI-conditional. This means it should not be used in or near an MRI environment, as its compatibility with magnetic fields has not been established.
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: FAST1™ IO Infusion System | US | Teleflex, FAST1™ Intraosseous Infusion System | Intraosseous Access | Emergency ..., FAST1 Intraosseous Infusion System - IV Medical - MED-TAC
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K080865 | Class II | Active |
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Manufacturer
- Manufacturer
- Pyng Medical Corp.
Sources (1)
- FDA 510(k) K080865 24 fields · synced Oct 1, 2026