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Vaculink, Model VCL 3000

by Medevco, Inc.

510(k) K043614

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK043614 Date14 Apr 2005ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
HDB
Device Class
Class II
Regulation
21 CFR Part 884.4340
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Vaculink, Model VCL 3000 is a single-use, battery-powered vacuum measuring accessory for fetal vacuum extractors. It is designed to measure vacuum pressure applied to the fetal head during assisted delivery procedures and displays values in cm Hg.

The device connects to the vacuum chamber of handheld extractors such as Mityvac or Kiwi and interfaces with maternal/fetal monitors via an electrical cable. It is supplied sterile for single-use use in clinical settings and is classified as a Class II medical device under FDA regulation 884.4340 with product code HDB.

Questions

AI-generated answers, 25 Sep 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 Vaculink Model VCL 3000 used for?

    The Vaculink Model VCL 3000 measures vacuum pressure applied to the fetal head during assisted delivery procedures, displaying values in cm Hg to help clinicians monitor and control suction levels for safer fetal extraction.

  • How is the Vaculink Model VCL 3000 supplied and is it reusable?

    The device is supplied sterile and is designed for single-use only; it must be discarded after each procedure to prevent cross-contamination and ensure accurate vacuum measurement, as reuse could compromise sterility and sensor integrity.

  • What equipment does the Vaculink Model VCL 3000 connect to?

    It connects to the vacuum chamber of handheld fetal extractors such as Mityvac or Kiwi devices and interfaces with maternal/fetal monitors via an electrical cable to transmit real-time vacuum pressure readings during delivery.