# K973942: Swift Delivery Product #300

- Pathway: 510(k) (Traditional)
- Applicant: Swift Delivery Products
- Decided: Dec 12, 1997 after 77 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: 2 generations back to K890307 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970170: Swift Delivery Product #002-Vac EX Cup W/Vac Rel Valve, Richard G. Lindsay (1997) Summary page 1.

## Indications for use
The Indications For Use for this vacuum device in childbirth are the following: Uterine inertia Maternal Exhaustion - ineffective voluntary effort Vertex Presentation Engagement of the Head Optional: A. Maternal distress B. Fetal distress

Source page: https://510kreport.com/device/K973942
Methodology: https://510kreport.com/methodology