# K250298: Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); 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)

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Innovations, LLC
- Decided: Oct 8, 2025 after 250 days
- Product code: HDB (Extractor, Vacuum, Fetal)
- Device class: 2
- Regulation: 21 CFR 884.4340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K890307 (1989). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981260: Kiwi Soft Cup with Palm Pump Model Number Vfe-6000S, Kiwi Mushroom Cup with Palm Pump Model Vfe-6000M, Clinical Innovations, Inc. (1998) Summary page 5.

## Indications for use
The Kiwi Complete Vacuum Delivery System (Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); 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)) is indicated for use in the following conditions: • Prolonged second stage of labor (arrest of descent) where fetopelvic relationships are adequate • Presumed fetal jeopardy that is not considered to be severe • Elective shortening of the second stage for selected maternal or fetal conditions

Source page: https://510kreport.com/device/K250298
Methodology: https://510kreport.com/methodology