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IV Bifurcated Extension Set

by Marquette Medical, Inc.

510(k) K900426

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 NumberK900426 Date28 Feb 1990ClearedStatusActive

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 880.5440
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 IV Bifurcated Extension Set is a medical device classified as a Set, Administration, Intravascular (product code FPA). It is designed to facilitate the administration of intravenous fluids or medications by extending the length of an existing intravenous line, allowing for bifurcation to connect multiple infusion sources or devices simultaneously. This configuration supports dual-line administration in clinical settings where two separate infusions are required.

This device is intended for single-use in hospital environments and is supplied sterile. It is regulated under FDA 510(k) clearance (K900426) and falls under Class II – Special Controls. The set is intended for use with intravenous therapy and must comply with standard sterility and safety protocols for intravenous administration. No additional regulatory status beyond the stated FDA clearance is implied.

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