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Pour Bottle Decanter #2010

by Medi-Plant Intl.

510(k) K823538

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 NumberK823538 Date26 Jan 1983ClearedStatusActive

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  • Withdrawn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 Pour Bottle Decanter #2010 is classified as an Intravenous (I.V.) Container, designed for the safe and controlled dispensing of intravenous fluids. It features a decanter mechanism to facilitate pouring without spillage, ensuring precise administration in clinical settings.

This device is intended for single-use in hospital environments and is supplied sterile. It is classified under FDA device class 2 and carries a 510(k) clearance (K823538) for traditional review, with a product code of KPE. Storage and handling must comply with standard sterile medical device protocols to maintain integrity and safety.

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 Pour Bottle Decanter #2010 used for?

    The Pour Bottle Decanter #2010 is designed as an intravenous (I.V.) container to safely and precisely dispense intravenous fluids in clinical environments. Its decanter mechanism allows controlled pouring without spillage, reducing the risk of contamination or waste during administration. This makes it ideal for scenarios where accurate fluid measurement and minimal handling are critical.

  • Is the Pour Bottle Decanter #2010 intended for single-use or reuse?

    This device is explicitly intended for single-use only in hospital settings. Single-use design ensures sterility and safety, as reuse could compromise the integrity of the container and introduce contamination risks. Always follow sterile handling protocols to maintain compliance with medical device standards.

  • How is the Pour Bottle Decanter #2010 supplied, and what sterility guarantees are included?

    The Pour Bottle Decanter #2010 is supplied sterile and packaged for single-use. Sterility is maintained through manufacturing controls and packaging designed to preserve integrity until first use. Always verify the packaging seal and expiration date before use to ensure sterility is intact.

  • What storage and handling requirements apply to this device?

    Storage and handling must comply with standard sterile medical device protocols to preserve the device’s integrity. Keep the Pour Bottle Decanter #2010 in its original, unopened packaging until ready for use. Store in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid exposure to moisture or contaminants that could compromise sterility.

  • Does this device require any specific regulatory approvals or clearances?

    The Pour Bottle Decanter #2010 holds an FDA 510(k) clearance (K823538) under traditional review, classified as a Class II device with product code KPE. This clearance confirms its substantial equivalence to a predicate device and compliance with FDA regulations for intravenous containers. Always refer to the device labeling and manufacturer documentation for the latest regulatory details.