Cleared Traditional

K250298 - Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M) (FDA 510(k) Clearance)

Also includes:
Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT) Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C) Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250298 · Clinical Innovations, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
250d
Days
Class 2
Risk

K250298 is an FDA 510(k) clearance for the Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M). Classified as Extractor, Vacuum, Fetal (product code HDB), Class II - Special Controls.

Submitted by Clinical Innovations, LLC (Murray, US). The FDA issued a Cleared decision on October 8, 2025 after a review of 250 days - an extended review cycle.

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 Clinical Innovations, LLC devices

Submission Details

510(k) Number K250298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2025
Decision Date October 08, 2025
Days to Decision 250 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 160d · This submission: 250d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.