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Free Flow Safety Device

by Migada, Ltd.

510(k) K954883

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 NumberK954883 Date23 Apr 1996ClearedStatusActive

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  • Withdrawn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
FPA
FDA applicant
Migada, Inc.
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Free Flow Safety Device is a medical device designed for intravenous fluid delivery. It may include components such as a needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors, a side tube with a cap for injection site use, and a hollow spike to connect tubing to an I.V. bag or other infusion fluid container.

The device is supplied as part of an infusion set and is intended for use in general hospital settings. It received FDA 510(k) clearance (K954883) on April 23, 1996, and is classified under product code FPA. The device is manufactured by Migada, Inc., located in Englewood Cliffs, New Jersey.

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