510(k) · Cleared
ClearedMityvac M Style Vacuum Extractor, Disposable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neward Enterprises, Inc. · HDB Extractor, Vacuum, Fetal
Cleared on Mar 31, 1989 after a 67-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Mar 31, 1989
- Review
- 67 days
- Class
- Class II
- Product code
- HDB
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK890307 Mityvac M Style Vacuum Extractor, DisposableNeward Enterprises, Inc. · 1989
- Descendant · cites it directly · 4 of its ownK970170 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 · 2 generations on · 0 of its ownK973942 Swift Delivery Product #300Swift Delivery Products · 1997
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K970170Swift Delivery Product #002-Vac EX Cup W/Vac Rel ValveRichard G. Lindsay · 1997 · cites it directly4descendants
- 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 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K890307 | Mityvac M Style Vacuum Extractor, Disposable | Neward Enterprises, Inc. | 1989 | — |
| +1 | 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 | — |
| +2 | K973942 | Swift Delivery Product #300 | Swift Delivery Products | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
3 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?
- Of its descendants, K970170 (Richard G. Lindsay, 1997) has gone furthest, with 4 descendants of its own.
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 | — |
https://510kreport.com/device/K890307 · printed Nov 5, 2026
Cite this page
510(k) Report. “K890307: Mityvac M Style Vacuum Extractor, Disposable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K890307
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026