# K970170: Swift Delivery Product #002-Vac EX Cup W/Vac Rel Valve

- Pathway: 510(k) (Traditional)
- Applicant: Richard G. Lindsay
- Decided: Mar 28, 1997 after 78 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: 1 generation back to K890307 (1989). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890307: Mityvac M Style Vacuum Extractor, Disposable, Neward Enterprises, Inc. (1989) Summary page 1.

## Most influential descendants
- K981260: Kiwi Soft Cup with Palm Pump Model Number Vfe-6000S, Kiwi Mushroom Cup with Palm Pump Model Vfe-6000M (1998), 2 descendants of its own
- 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) (2025), 0 descendants of its own
- K043614: Vaculink, Model VCL 3000 (2005), 0 descendants of its own
- K973942: Swift Delivery Product #300 (1997), 0 descendants of its own

## Indications for use
Vacuum Extractor Cup used in child birth

Source page: https://510kreport.com/device/K970170
Methodology: https://510kreport.com/methodology