# K041579: Medela Single Use Silc Cup, Model 077.0791

- Pathway: 510(k) (Traditional)
- Applicant: Medela AG
- Decided: Apr 21, 2005 after 311 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 K841492 (1984). 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)
- K841492: AB Vacuum Extractor Silc-Cup, Medela, Inc. (1984) Summary page 1.
- K895700: Ameda/Egnell Dolphin Dispo-Soft Vacuum Extractor, Hollister, Inc. (1990) Summary page 1.

## Indications for use
Fetal distress in the second stage Maternal delay in the second stage Maternal conditions requiring a short second stage The Medela® Obstetrical Vacuum Delivery System (Single Use Sile Cup) is a sterile, disposable device intended to be used to facilitate the delivery of the fetus during childbirth. The device enables traction to be applied to the fetal head (in the birth canal) by means of a suction cup attached to the scalp. It is powered by an external vacuum source and indicated for using during vaginal or cesarean delivery.

Source page: https://510kreport.com/device/K041579
Methodology: https://510kreport.com/methodology