# K043614: Vaculink, Model VCL 3000

- Pathway: 510(k) (Traditional)
- Applicant: Medevco, Inc.
- Decided: Apr 14, 2005 after 105 days
- Product code: HDB (Extractor, Vacuum, Fetal)
- Device class: 2
- Regulation: 21 CFR 884.4340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K890307 (1989). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981260: Kiwi Soft Cup with Palm Pump Model Number Vfe-6000S, Kiwi Mushroom Cup with Palm Pump Model Vfe-6000M, Clinical Innovations, Inc. (1998) Summary page 1.
- K011532: Mityvac, Prism Enterprises, Inc. (2001). 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”.

## Indications for use
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.

Source page: https://510kreport.com/device/K043614
Methodology: https://510kreport.com/methodology