510(k) · Cleared
ClearedSwift Delivery Product #002-Vac EX Cup W/Vac Rel Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard G. Lindsay · HDB Extractor, Vacuum, Fetal
Cleared on Mar 28, 1997 as substantially equivalent to K890307 (Neward Enterprises, Inc., 1989) after a 78-day review. Its family tree reaches back 1 generation to 1989. 4 later devices descend from it.
- Decided
- Mar 28, 1997
- Review
- 78 days
- Class
- Class II
- Product code
- HDB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K890307 (1989). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK890307 Mityvac M Style Vacuum Extractor, DisposableNeward Enterprises, Inc. · 1989
- This deviceK970170 Swift Delivery Product #002-Vac EX Cup W/Vac Rel ValveRichard G. Lindsay · 1997
- Descendant · cites it directly · 2 of its ownK981260 Kiwi Soft Cup with Palm Pump Model Number Vfe-6000S, Kiwi Mushroom…Clinical Innovations, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 0 of its ownK250298 Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi®…Clinical Innovations, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK043614 Vaculink, Model VCL 3000Medevco, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK973942 Swift Delivery Product #300Swift Delivery Products · 1997
Most influential descendants
Showing 4 of 4 · See all- K981260Kiwi Soft Cup with Palm Pump Model Number Vfe-6000S, Kiwi Mushroom Cup with Palm Pump…Clinical Innovations, Inc. · 1998 · cites it directly2descendants
- K250298Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum…Clinical Innovations, LLC · 2025 · 2 generations on0descendants
- K043614Vaculink, Model VCL 3000Medevco, Inc. · 2005 · 2 generations on0descendants
- K973942Swift Delivery Product #300Swift Delivery Products · 1997 · cites it directly0descendants
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) | K970170 | Swift Delivery Product #002-Vac EX Cup W/Vac Rel Valve | Richard G. Lindsay | 1997 | — |
| +1 | K981260 | Kiwi Soft Cup with Palm Pump Model Number Vfe-6000S, Kiwi Mushroom Cup with… | Clinical Innovations, Inc. | 1998 | 2 |
| +2 | K250298 | Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete… | Clinical Innovations, LLC | 2025 | — |
| +2 | K043614 | Vaculink, Model VCL 3000 | Medevco, Inc. | 2005 | — |
| +1 | K973942 | Swift Delivery Product #300 | Swift Delivery Products | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
| 2025 | 1 | 0 |
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…anel: OB/GYN Product Code: 85HDSB C.F.R. Section: CFR - 21 (884.4340) Device Class: Class |1 Indication Use: Vacuum Extractor Cup used in child birth Equivalence to: K890307 Mityvac Vacuum Extractor with release valve Description of the Device: The new product is an improved vacuum extractor cup. The… | 1989 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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/K970170 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970170: Swift Delivery Product #002-Vac EX Cup W/Vac Rel Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970170
Report an extraction error
Are you the manufacturer?
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