510(k) · Cleared
ClearedVaculink, Model VCL 3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medevco, Inc. · HDB Extractor, Vacuum, Fetal
Cleared on Apr 14, 2005 as substantially equivalent to K981260 (Clinical Innovations, Inc., 1998) and 1 other predicate after a 105-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Apr 14, 2005
- Review
- 105 days
- Class
- Class II
- Product code
- HDB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K890307 (1989). 8 ancestors in all, the oldest K881967 (1988). No later device cites it as a predicate yet.
- Root · 3 generations backK890307 Mityvac M Style Vacuum Extractor, DisposableNeward Enterprises, Inc. · 1989
- 2 generations backK970170 Swift Delivery Product #002-Vac EX Cup W/Vac Rel ValveRichard G. Lindsay · 1997
- 1 generation backK981260 Kiwi Soft Cup with Palm Pump Model Number Vfe-6000S, Kiwi Mushroom…Clinical Innovations, Inc. · 1998 · Recalled
- This deviceK043614 Vaculink, Model VCL 3000Medevco, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K890307 | Mityvac M Style Vacuum Extractor, Disposable | Neward Enterprises, Inc. | 1989 | — |
| −2 | 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 |
| 0 (this device) | K043614 | Vaculink, Model VCL 3000 | Medevco, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 2001 | 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? (2)
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 |
|---|---|---|---|
| * | K981260 | Kiwi Soft Cup with Palm Pump Model Number Vfe-6000S, Kiwi Mushroom Cup with Palm Pump…Summary page 1…vice: This device is substantially equivalent to the vacuum indicator features of Kiwi brand fetal vacuum extractor systems marketed by Clinical Innovations, Inc., under K981260, and Mityvac brand vacuum extractor systems marketed by Prism Enterprises (now CooperSurgical) under KO0 1532. Description: The V… | 1998 |
| * | K011532 | Mityvac Our reading of the summary gave K001532, FDA’s number for Dyna-Lok Classic Spinal System (Medtronic Sofamor Danek, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Mityvac brand vacuum extractor systems”. | 2001 |
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?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K981260.
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 VacuLink is intended for obstetric use in the measurement and recording of data related to vacuum-assisted delivery (such as vacuum, number and duration of pulls and number of pop-offs) on the strip chart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043614 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043614: Vaculink, Model VCL 3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043614
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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