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Large Bore Stopcock with Rotating Male Luer Lock/Large Bore Stopcock with Extension Set, Gang Large Bore Stopcock Manifo

by Baxter Healthcare Corp

510(k) K130245

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 · Special NumberK130245 Date1 Mar 2013ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0189-2026 FDA Class II initiated 29 Aug 2025

    IV sets may leak.

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  • Withdrawn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
FMG
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 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 large bore stopcock with rotating male luer lock and extension set, configured as a gang manifold. It is designed for use in general hospital settings as an intravenous (IV) stopcock system.

It is supplied as a reusable or single-use component depending on configuration, non-sterile unless otherwise specified, and not indicated for MRI safety. The device received FDA 510(k) clearance (K130245) as substantially equivalent to a predicate device, classified as a Class II stopcock under regulation number 880.5440.

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