Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

Infusion Sets with Precision Filters for Single Use (with Needles)

Model / Reference

Type: A, 6225

Primary DI / UDI-DI

06949230162253

Basic UDI-DI

69492301JMSYQ013S

510(k) Number

K181870 ↗

FDA Product Code

FPA

EMDN Code

A03010102 Infusion controllers with filter (also transfusion controllers)

Device Class

Class IIa EUDAMED

Class II 510(k)

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Are these infusion sets reusable or designed for single-use only, and how is sterility maintained during storage?

  These infusion sets are explicitly designed for single-use only, as stated in the device description. Sterility is maintained through individual packaging for each set, which preserves a sterile barrier until first use. Since no reuse is permitted, the packaging ensures that each set remains uncontaminated and safe for one administration only.

• What types of infusion sets are included in this product line, and how do the standard and extended versions differ?

  This product line includes three variants: standard *Infusion Sets with Precision Filter*, *Precision Infusion Filter Sets*, and *Extended Infusion Sets*. The standard sets are optimized for shorter infusion procedures, while the extended versions are designed for prolonged administration, accommodating longer infusion durations without compromising precision or safety.

• What regulatory pathways have these infusion sets undergone, and which classification applies to their use in hospitals?

  These infusion sets were cleared through the FDA 510(k) pathway under reference K181870, with a decision of *Substantially Equivalent* (SESE) and classified under the General Hospital advisory committee (HO). They also comply with the MDR (Medical Device Regulation) requirements, ensuring suitability for use in standard hospital environments.

• Are there any specific storage instructions provided for these infusion sets, or should they be kept under standard conditions?

  The submitted data does not specify detailed storage conditions for these infusion sets. However, since they are packaged individually to maintain sterility, they should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow facility protocols for sterile medical devices until use.