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Decanter Models-Various

by Steri-Sytems, Corp.

510(k) K830232

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 NumberK830232 Date9 Feb 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  • Withdrawn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, 24 Sep 2026

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

This device is a Container, I.V., as classified under regulation number 880.5025. It is a decanter model used for intravenous fluid handling, substantially equivalent to a legally marketed device.

It was cleared via the traditional 510(k) pathway under K830232 by Steri-Sytems, Corp., with a decision date of February 9, 1983. The device is intended for general hospital use and is supplied as a non-sterile, reusable accessory for IV containers.

Questions

AI-generated answers, 24 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 DECANTER MODELS-VARIOUS used for?

    The DECANTER MODELS-VARIOUS is a Container, I.V. decanter used for intravenous fluid handling in general hospital settings, designed as a reusable accessory for IV containers based on its 510(k) clearance.

  • Is the DECANTER MODELS-VARIOUS sterile or non-sterile, and is it single-use or reusable?

    The device is supplied as a non-sterile, reusable accessory for IV containers, as explicitly stated in its description, meaning it is intended for multiple uses after appropriate cleaning and is not provided in a sterile condition.

  • How was the DECANTER MODELS-VARIOUS cleared for market, and what is its regulatory pathway?

    The DECANTER MODELS-VARIOUS was cleared via the traditional 510(k) pathway under submission K830232 by Steri-Sytems, Corp., with a decision date of February 9, 1983, based on substantial equivalence to a legally marketed device.