# K980976: Ameda Disposable Vacuum Assist Cup with Fluid Retention Trap

- Pathway: 510(k) (Traditional)
- Applicant: Hollister, Inc.
- Decided: Aug 21, 1998 after 158 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 K895700 (1990). 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)
- K895700: Ameda/Egnell Dolphin Dispo-Soft Vacuum Extractor, Hollister, Inc. (1990) Summary page 1.
- (no number) Mityvac Obstetrical Vacuum Extraction System by Neward Enterprises: named in the summary without a submission number
- (no number) Tender Touch Obstetrical Vacuum Delivery Kit by Columbia Medical Inc.: named in the summary without a submission number

## Indications for use
The Ameda Disposable Vacuum Assist Cup with Fluid Retention Trap is a sterile, single use, device intended to be connected to an externally powered fetal vacuum extractor to aid in vaginal or Cesarean delivery of term or near term infants. The Fluid Retention Trap is intended to collect fluids aspirated during the delivery procedure. Delay in second stage with the fetal head stationed at the outlet; on the pelvic floor; or in the mid-pelvis. Delay in the second stage associated with borderline cephalopelvic disproportion Fetal distress Shortening of second stage labor for fetal or maternal benefit Prolapse of the umbilical cord when the cervix is fully dilated

Source page: https://510kreport.com/device/K980976
Methodology: https://510kreport.com/methodology