510(k) · Cleared
ClearedAmeda Disposable Vacuum Assist Cup with Fluid Retention Trap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hollister, Inc. · HDB Extractor, Vacuum, Fetal
Cleared on Aug 21, 1998 as substantially equivalent to K895700 (Hollister, Inc., 1990) after a 158-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Aug 21, 1998
- Review
- 158 days
- Class
- Class II
- Product code
- HDB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K895700 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK895700 Ameda/Egnell Dolphin Dispo-Soft Vacuum ExtractorHollister, Inc. · 1990
- This deviceK980976 Ameda Disposable Vacuum Assist Cup with Fluid Retention TrapHollister, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895700 | Ameda/Egnell Dolphin Dispo-Soft Vacuum Extractor | Hollister, Inc. | 1990 | — |
| 0 (this device) | K980976 | Ameda Disposable Vacuum Assist Cup with Fluid Retention Trap | Hollister, Inc. | 1998 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HDB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HDB device
- #1 K250298 Kiwi® Complete Vacuum Delivery System…score 10.7 · 3 generations · no Class I recall
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K895700 | Ameda/Egnell Dolphin Dispo-Soft Vacuum ExtractorSummary page 1…red - March 11, 1998 2. Name of Device: Ameda Disposable Vacuum Assist Cup with Fluid Retention Trap 3. Name of Predicate Device(s) Ameda Disposable Vacuum Assist Cup, K895700 Mityvac Obstetrical Vacuum Extraction System by Neward Enterprises Tender Touch Obstetrical Vacuum Delivery Kit by Columbia Medic… | 1990 |
| * | — | Mityvac Obstetrical Vacuum Extraction System by Neward Enterprises Named without a submission number | |
| * | — | Tender Touch Obstetrical Vacuum Delivery Kit by Columbia Medical Inc. Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K895700.
How does its category compare?
All HDB devicesHDB Extractor, Vacuum, Fetal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HDB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HDB
Too few HDB 510(k)s in any year since 2007 to give a median.
Recalls per year · HDB
3in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HDB
17in 2025
MAUDE reports naming product code HDB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 25 |
| 2008 | 0 | — | 3 | 35 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 0 | — | 0 | 8 |
| 2012 | 0 | — | 0 | 9 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 11 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 0 | — | 0 | 15 |
| 2017 | 0 | — | 0 | 16 |
| 2018 | 0 | — | 0 | 25 |
| 2019 | 0 | — | 0 | 31 |
| 2020 | 0 | — | 0 | 24 |
| 2021 | 0 | — | 0 | 21 |
| 2022 | 0 | — | 0 | 12 |
| 2023 | 0 | — | 0 | 23 |
| 2024 | 0 | — | 0 | 24 |
| 2025 | 1 | — | 0 | 17 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980976 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980976: Ameda Disposable Vacuum Assist Cup with Fluid Retention Trap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980976
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026