# K190105: ZOOM Aspiration Pump

- Pathway: 510(k) (Special)
- Applicant: Taiwan Biomaterial Co., Ltd.
- Decided: Feb 21, 2019 after 30 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 K122756 (2012). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180115: TWBM Pump, Taiwan Biomaterial Co., Ltd. (2018) Summary page 4.

## Indications for use
ZOOM Aspiration Pump The ZOOM Aspiration Pump is intended for general suction use in hospitals or clinics. ZOOM Canister The ZOOM Canister is intended to collect aspirated fluids for disposal and prevent fluid ingress from damaging the ZOOM Aspiration Pump. ZOOM Aspiration Tubing The ZOOM Aspiration Tubing Set is intended to connect a suction catheter to the ZOOM Canister of the ZOOM Aspiration Pump and to allow the user to control the fluid flow.

Source page: https://510kreport.com/device/K190105
Methodology: https://510kreport.com/methodology