# K013460: Swift Low Profile Cup (Pro Cup)

- Pathway: 510(k) (Traditional)
- Applicant: Swift Delivery Products
- Decided: Jan 17, 2002 after 91 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
1. Non-reassuring fetal status. 2. Failure of the fetus to deliver spontaneously following an appropriately managed second stage, 3. Maternal need to avoid voluntary expulsive effort, Inadequate maternal expulsive effort. 5. Selective shortening of the second stage when the fetal head is at the outlet as defined by ACOG technical bulletin # 196 Aug. 1994.

Source page: https://510kreport.com/device/K013460
Methodology: https://510kreport.com/methodology