# K180115: TWBM Pump

- Pathway: 510(k) (Traditional)
- Applicant: Taiwan Biomaterial Co., Ltd.
- Decided: Jul 24, 2018 after 189 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: 1 generation back to K122756 (2012). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122756: Penumbra Pump Max (110VAC), Penumbra Pump Max (230VAC), Penumbar Pump Max Canister/Tubing, Penumbra, Inc. (2012) Summary page 4.

## Most influential descendants
- K190105: ZOOM Aspiration Pump (2019), 0 descendants of its own

## Indications for use
TWBM Pump is intended for general suction use in hospitals or clinics.

Source page: https://510kreport.com/device/K180115
Methodology: https://510kreport.com/methodology