# K103535: Vacplus Suction Unit

- Pathway: 510(k) (Traditional)
- Applicant: Apex Medical Corp.
- Decided: Feb 24, 2011 after 85 days
- Product code: JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K935218 (1994). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982304: Devilbiss Suction Unit, Sunrise Medical Hhg, Inc. (1998) Summary page 1.

## Most influential descendants
- K182950: Acare Suction Unit (2019), 1 descendant of its own
- K250964: Protable Phlegm Suction Unit (JMA D01) (2026), 0 descendants of its own

## Indications for use
The device is to be used to remove fluids from the treated tracheotomy patient airway.

Source page: https://510kreport.com/device/K103535
Methodology: https://510kreport.com/methodology