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Aseptic Transfer Set

by Heyer Schulte Corp.

510(k) K780417

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 NumberK780417 Date18 Apr 1978ClearedStatusActive

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  • Withdrawn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
GAZ
Device Class
Class II
Regulation
21 CFR Part 880.6740
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Aseptic Transfer Set is a sterile medical device designed for the safe transfer of fluids or substances between containers while maintaining aseptic conditions. It is classified under the FDA product code GAZ and is intended for use in general hospital settings to prevent contamination during procedures requiring sterile transfer, such as medication preparation or specimen handling.

This single-use device is supplied sterile and intended for one-time use only. It is regulated under FDA 510(k) clearance (K780417) with a traditional review process, classified as substantially equivalent to the predicate device. No MRI safety or reusable specifications are indicated in the regulatory data.

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Questions

AI-generated answers, 18 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 Aseptic Transfer Set primarily used for in a clinical setting?

    The Aseptic Transfer Set is designed for maintaining sterile conditions during the transfer of fluids or substances between containers. This is particularly useful in general hospital settings for procedures like medication preparation or specimen handling, where contamination risks must be minimized.

  • Is the Aseptic Transfer Set intended for single-use or repeated use, and why?

    The Aseptic Transfer Set is explicitly intended for single-use only. This is because maintaining aseptic conditions during fluid transfer requires a sterile, uncontaminated device, and reuse could compromise sterility and introduce infection risks.

  • How is the Aseptic Transfer Set supplied, and what does that mean for its handling?

    The Aseptic Transfer Set is supplied sterile and packaged for one-time use. This means it should be opened only immediately before use, and any unused portion should be discarded to prevent contamination. The sterile packaging ensures the device remains uncontaminated until first use.

  • What regulatory pathway was followed for FDA clearance of this device, and what does that imply about its safety and equivalence?

    The Aseptic Transfer Set received FDA clearance through a 510(k) submission (K780417) with a traditional review process, classified as *substantially equivalent* to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared device, ensuring it meets safety and effectiveness standards for its intended sterile transfer applications.