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Stopcocks

by Transamerica Delaval, Inc.

510(k) K851986

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

10 closed

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 NumberK851986 Date23 May 1985ClearedStatusActive

Recalls

10 recalls · FDA

  • 10 recalls, same reason

    • Terminated Z-0235-05 FDA Unclassified (pre-2012) initiated 9 Sep 2004
    • Terminated Z-0241-05 FDA Unclassified (pre-2012) initiated 9 Sep 2004
    • Terminated Z-0234-05 FDA Unclassified (pre-2012) initiated 9 Sep 2004
    • Terminated Z-0237-05 FDA Unclassified (pre-2012) initiated 9 Sep 2004
    • Terminated Z-0238-05 FDA Unclassified (pre-2012) initiated 9 Sep 2004
    • Terminated Z-0236-05 FDA Unclassified (pre-2012) initiated 9 Sep 2004
    • Terminated Z-0242-05 FDA Unclassified (pre-2012) initiated 9 Sep 2004
    • Terminated Z-0243-05 FDA Unclassified (pre-2012) initiated 9 Sep 2004
    • Terminated Z-0240-05 FDA Unclassified (pre-2012) initiated 9 Sep 2004
    • Terminated Z-0239-05 FDA Unclassified (pre-2012) initiated 9 Sep 2004

    Sterility of the device is compromised due to packaging defects

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  • Withdrawn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.

The Stopcocks are medical devices classified as part of an I.V. set. They are designed to control the flow of fluids within intravenous administration systems.

This device is regulated under FDA 510(k) clearance K851986. It is manufactured by Transamerica Delaval, Inc. and is categorized under the general hospital medical specialty.

Other devices from Transamerica Delaval, Inc.

Questions

AI-generated answers, 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.

  • What is the primary function of these stopcocks?

    These stopcocks are designed to control the flow of fluids within intravenous administration systems, serving as a component of an I.V. set.

  • Who is the manufacturer and what is the regulatory status of this device?

    This device is manufactured by Transamerica Delaval, Inc. and is regulated under FDA 510(k) clearance K851986.

  • What medical specialty and regulatory classification do these stopcocks fall under?

    The stopcocks are categorized under the general hospital medical specialty and are classified as part of an I.V. set under regulation number 880.5440.