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Safety-Multifly

FDA 510(k)

Class II (US FDA 510(k))

510(k) K032150

by Sarstedt, Inc.

Identifiers

510(k) Number
K032150 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 Safety-Multifly is a needle device with a safety mechanism and multi-adapter. It is designed for medical procedures requiring venous access, with various gauge sizes available including 21G and 23G. The device features a protective mechanism to enhance safety during use.

The Safety-Multifly is supplied as a sterile, single-use device. It is available in different sizes with tube lengths of 240mm and 80mm. The device has received FDA 510(k) clearance with product code FPA and was determined to be substantially equivalent.

Frequently asked questions

What clinical procedures is the Safety-Multifly intended for?

The device is designed for venous access procedures, such as phlebotomy or intravenous catheter placement, where a needle is required to obtain or maintain access to a vein.

In what sizes and tube lengths is the Safety-Multifly supplied?

It is provided in 21‑gauge and 23‑gauge needle sizes, each available with tube lengths of either 240 mm or 80 mm, allowing clinicians to select the configuration that best fits the procedure.

Is the Safety-Multifly sterile and single‑use?

Yes, each unit is supplied sterile and intended for a single patient use only, which helps maintain infection control and eliminates the need for re‑processing.

How does the safety mechanism of the Safety-Multifly work?

The needle incorporates a built‑in protective mechanism that automatically shields the sharp tip after use, reducing the risk of needlestick injuries to healthcare personnel.

What regulatory pathway did the Safety-Multifly follow?

The device received FDA 510(k) clearance under product code FPA, indicating it was found substantially equivalent to a legally marketed predicate device.

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: Safety-Multifly® PRO - sarstedt.com, Safety-Multifly® needle, 21G x 3/4'', green, tube length: 240 mm, 1 ..., Safety Multifly® cannula from Sarstedt - Praxisdienst, SARSTEDT SAFETY-MULTIFLY INSTRUCTIONS Pdf Download, Sarstedt Inc Safety-Multifly needle, 23G x 3/4'', blue, Tube length: 80 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sarstedt, Inc.

Sources (1)

  • FDA 510(k) K032150 24 fields · synced Sep 28, 2026