510(k) · Cleared
ClearedVacuum Cup (004SD)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Swift Delivery Products · HDB Extractor, Vacuum, Fetal
Cleared on Oct 28, 1996 as substantially equivalent to K890307 (Neward Enterprises, Inc., 1989) after a 68-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Oct 28, 1996
- Review
- 68 days
- Class
- Class II
- Product code
- HDB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K890307 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK890307 Mityvac M Style Vacuum Extractor, DisposableNeward Enterprises, Inc. · 1989
- This deviceK963287 Vacuum Cup (004SD)Swift Delivery Products · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890307 | Mityvac M Style Vacuum Extractor, Disposable | Neward Enterprises, Inc. | 1989 | — |
| 0 (this device) | K963287 | Vacuum Cup (004SD) | Swift Delivery Products | 1996 | — |
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? (1)
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 |
|---|---|---|---|
| * | K890307 | Mityvac M Style Vacuum Extractor, DisposableSummary page 1…Panel: OB/GYN Product Code: 85HDB C.F.R. Section: CFR -21 (884.4340) Device Class: Class 11 Indication Use: Vacuum Extractor Cup used in child birth Equivalence to: K890307 Mityvac@V acuum Extractor 004M Description of the device: The new Tulip Cup is a design change to the current Mityvac@ (004M) v… | 1989 |
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.
- 2 other devices also cite its predicate K890307.
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?
Vacuum Extractor Cup used in child birth
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/K963287 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963287: Vacuum Cup (004SD).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963287
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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