# K963287: Vacuum Cup (004SD)

- Pathway: 510(k) (Traditional)
- Applicant: Swift Delivery Products
- Decided: Oct 28, 1996 after 68 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.
No later device cites it as a predicate yet.
0 of 2 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.

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

Source page: https://510kreport.com/device/K963287
Methodology: https://510kreport.com/methodology