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River Vial Adapter

by River Medical, Inc.

510(k) K933335

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 NumberK933335 Date1 Mar 1994ClearedStatusActive

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  • Withdrawn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
FMF
Device Class
Class II
Regulation
21 CFR Part 880.5860
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 River Vial Adapter is a medical device classified under the FDA’s General Hospital category (product code FMF). It serves as an intermediary connector designed to facilitate the transfer of fluids or medications between a vial and another compatible system, ensuring compatibility and sterility during the process. This adapter is intended for use in clinical settings where precise fluid transfer is required, such as in pharmacy compounding or intravenous preparation.

The device is supplied as a single-use, non-sterile component and is intended for use in non-MRI environments. It is cleared under the FDA’s 510(k) pathway (K933335) as substantially equivalent to a predicate device, with no additional regulatory markings or sterility guarantees specified beyond its intended single-use application. Storage instructions are not detailed in the data, but standard medical device handling practices should apply. No further authorisations beyond the 1994 FDA clearance are referenced.

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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 River Vial Adapter used for?

    The River Vial Adapter is designed as an intermediary connector to transfer fluids or medications between a vial and another compatible system. It ensures compatibility and sterility during the process, making it suitable for clinical settings like pharmacy compounding or intravenous preparation where precise fluid transfer is critical.

  • Is the River Vial Adapter sterile or single-use?

    The River Vial Adapter is supplied as a single-use, non-sterile component. It is intended for one-time use only, and no additional sterility guarantees are specified beyond its single-use application.

  • Can this adapter be used in MRI environments?

    No, the River Vial Adapter is explicitly intended for use in non-MRI environments. This limitation is noted in its intended use specifications.

  • What regulatory pathway does the River Vial Adapter follow?

    The River Vial Adapter is cleared under the FDA’s 510(k) pathway (K933335) as substantially equivalent to a predicate device. It falls under the General Hospital category (product code FMF) and was originally cleared in 1994.

  • How should the River Vial Adapter be stored?

    While specific storage instructions are not detailed, standard medical device handling practices should be followed. This includes maintaining a clean, dry environment and protecting the adapter from contamination or physical damage.