Cleared Traditional

K043614 - VACULINK, MODEL VCL 3000

K043614 is an FDA 510(k) clearance for VACULINK, manufactured by Medevco, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HDB cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K043614 · Medevco, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
105d
Days
Class 2
Risk

K043614 is an FDA 510(k) clearance for the VACULINK, MODEL VCL 3000. Classified as Extractor, Vacuum, Fetal (product code HDB), Class II - Special Controls.

Submitted by Medevco, Inc. (Plano, US). The FDA issued a Cleared decision on April 14, 2005 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4340 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medevco, Inc. devices

FDA 510(k) Submission Details - K043614

510(k) Number K043614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2004
Decision Date April 14, 2005
Days to Decision 105 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 160d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HDB Device Classification - Class 2, Special Controls

Product Code HDB Extractor, Vacuum, Fetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HDB Extractor, Vacuum, Fetal

All 14
Devices cleared under the same product code (HDB) and FDA review panel - the closest regulatory comparables to K043614.
Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M)
K250298 · Clinical Innovations, LLC · Oct 2025
MEDELA SINGLE USE SILC CUP, MODEL 077.0791
K041579 · Medela AG · Apr 2005
KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M
K981260 · Clinical Innovations, Inc. · Sep 1998
AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP
K980976 · Hollister, Inc. · Aug 1998
MITYVAC
K980212 · Prism Technologies, Inc. · Jul 1998
SWIFT DELIVERY PRODUCT #300
K973942 · Swift Delivery Products · Dec 1997