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Set For Aseptic Decanting Of A Flex I.V

by Dip, Inc. 510(k)

Active United States

510(k) K812852

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK812852 Date2 Nov 1981ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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, 25 Sep 2026

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

The Set for Aseptic Decanting of a Flex I.V is an intravenous container decanting device. It is designed to facilitate the aseptic transfer of fluids from flexible intravenous solution containers.

This device is authorized under FDA 510(k) clearance K812852. It is intended for use in a general hospital setting to maintain sterility during the decanting process.

Other devices from Dip, Inc.

Questions

AI-generated answers, 25 Sep 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 primary purpose of this device?

    This device is designed to facilitate the aseptic transfer of fluids from flexible intravenous solution containers, helping to maintain sterility during the decanting process in a general hospital setting.

  • What is the regulatory status of this device?

    The Set for Aseptic Decanting of a Flex I.V. is authorized under FDA 510(k) clearance number K812852.

  • In what environment is this device intended to be used?

    This device is intended for use within a general hospital setting, where it serves to support the aseptic decanting of fluids from flexible intravenous containers.