ET Extension Sets

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

510(k) Number

K853387 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• High Flow I.V. Set

  Class II

  FDA 510(k) K861275 Active Cleared 2 Jun 1986

• Filter Set 1) 1.2 Mic Filter 2) 3.0 Mic Filter

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  FDA 510(k) K860605 Active Cleared 24 Mar 1986

• Arterial Blood Gassing Monitoring System (ABG)

  Class III

  FDA 510(k) K870016 Active Cleared 28 May 1987

• I.A.S.S., IV Set W/Air Vent & I.A.P.S. W/O Airvent

  Class II

  FDA 510(k) K853385 Active Cleared 23 Aug 1985

• Lab-Site(R) Safety Cannula

  Class II

  FDA 510(k) K933929 Active Cleared 7 Dec 1993

• IV Sets with No Phthalate Plasticizer Components

  Class II

  FDA 510(k) K854365 Active Cleared 24 Mar 1986

See all devices from Migada, Ltd. →

• What is the primary purpose of the ET Extension Sets from Migada, Ltd.?

  The ET Extension Sets are designed to connect enteral feeding tubes to infusion systems, allowing for the administration of nutrients, fluids, or medications through the gastrointestinal tract. They create a sterile pathway between the feeding tube and the infusion source, supporting both continuous and intermittent feeding regimens in hospital settings.

• Are these extension sets intended for reuse or are they single-use devices?

  These ET Extension Sets are explicitly labeled as single-use devices, meaning they are meant to be used once and then discarded. This designation ensures sterility and safety for each patient, adhering to standard medical practice for enteral feeding accessories.

• How should I store the ET Extension Sets to maintain their sterility before use?

  To preserve sterility, store the ET Extension Sets in their original packaging until ready for use. Follow standard aseptic techniques, such as keeping them in a clean, dry environment away from direct sunlight or contamination sources, to ensure they remain uncontaminated prior to administration.

• What regulatory pathway was followed for FDA clearance of these extension sets?

  The ET Extension Sets received FDA clearance through a Traditional 510(k) process, determined to be *Substantially Equivalent* to a predicate device. The submission was reviewed by the General Hospital (HO) Advisory Committee and received clearance under K-number K853387, classified under FDA Product Code FPA (Extension Tubes for Enteral Feeding).