# K021193: Fortune Silicone Vacuum Suction, Model #1300

- Pathway: 510(k) (Traditional)
- Applicant: Fortune Medical Instrument Corp.
- Decided: Feb 12, 2003 after 303 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
The Silicone Vacuum Cup is to assist a clinician in delivery of an infant during childbirth.

Source page: https://510kreport.com/device/K021193
Methodology: https://510kreport.com/methodology