# K030935: Berkeley V-10 Vacuum Curettage System

- Pathway: 510(k) (Traditional)
- Applicant: Acmi Corporation
- Decided: Jun 23, 2003 after 90 days
- Product code: HHI (System, Abortion, Vacuum)
- Device class: 2
- Regulation: 21 CFR 884.5070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K813282 (1981). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K813282: Synevac Vacuum Curettage Systems, Synemed, Inc. (1981) Summary page 1.
- (no number) Berkeley VC-2 Vacuum Curettage System: named in the summary without a submission number

## Most influential descendants
- K093508: Rigid Cannulae Curved (RC6-RC12), Rigid Cannulae Straight (RS6-RS12) (2010), 2 descendants of its own
- K140213: Disposable Endoscopic Cannula (2015), 1 descendant of its own
- K251882: Uterine Aspiration Set (2025), 0 descendants of its own
- K172151: Hysteroscopy System (2018), 0 descendants of its own
- K171440: Berkeley VC-10 Vacuum Curettage System (2017), 0 descendants of its own

## Recalls of this device
- Sep 12, 2019 · Class II · Z-0159-2020: Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could separate

## Indications for use
For rapid transcervical aspiration of the uterine cavity.

Source page: https://510kreport.com/device/K030935
Methodology: https://510kreport.com/methodology