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PharmaFeed

by Plasco, Inc.

510(k) K932649

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK932649 Date16 Nov 1993ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KPE
Device Class
Class II
Regulation
21 CFR Part 880.5025
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The PharmaFeed is an intravenous (I.V.) container designed for the administration of fluids and medications in clinical settings. Classified under product code KPE, it is intended for use in general hospital environments to deliver parenteral solutions, including nutrients, electrolytes, or medications directly into the bloodstream. Its construction and labeling comply with standards for intravenous administration systems, ensuring compatibility with standard infusion equipment and protocols.

This device is supplied as a single-use, sterile container and is regulated under FDA 510(k) clearance (K932649), classified as a Class II medical device under special controls. It is intended for use in hospital settings and must be handled according to aseptic techniques to maintain sterility. The device is not MRI-safe or reusable; it is discarded after single-use. Storage conditions must adhere to manufacturer guidelines to preserve sterility and integrity until use.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the PharmaFeed used for in clinical settings?

    The PharmaFeed is designed for intravenous administration of fluids, medications, electrolytes, or nutrients directly into the bloodstream. It is specifically intended for use in general hospital environments where parenteral solutions are required, ensuring compatibility with standard infusion equipment and protocols.

  • Is the PharmaFeed reusable or single-use?

    The PharmaFeed is strictly a single-use device. It is manufactured sterile and must be discarded after one use to maintain patient safety and prevent contamination. Reuse is not permitted as it could compromise sterility and integrity.

  • What storage conditions are required to preserve the PharmaFeed’s sterility?

    The PharmaFeed must be stored according to the manufacturer’s guidelines to preserve its sterility and structural integrity. This typically includes keeping it in a clean, dry environment, away from direct sunlight or extreme temperatures, and ensuring the packaging remains unopened until use.

  • Can the PharmaFeed be used with MRI equipment?

    No, the PharmaFeed is not MRI-safe. It should not be used in or near MRI environments, as exposure to magnetic fields could pose risks to the device or the patient.

  • What regulatory clearance does the PharmaFeed hold?

    The PharmaFeed is cleared by the FDA under the 510(k) pathway (K932649) and classified as a Class II medical device under special controls. This clearance confirms its compliance with U.S. regulations for intravenous administration systems.