# K071607: ASA01 Heavy Duty Suction Pump

- Pathway: 510(k) (Traditional)
- Applicant: Zhongshan A&J Medical Equipment Co., Ltd.
- Decided: Jun 26, 2007 after 14 days
- Product code: BTA (Pump, Portable, Aspiration (Manual Or 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 K052650 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052650: Pioneer U601 Series Aspirator, Merits Health Products Co., Ltd. (2005) Summary page 1.

## Indications for use
The ASA01 Heavy Duty Suction Pump is a vacuum suction device designed to remove bodily fluids from the patients' airway or respiratory support system. It is intended for use by trained personnel under the direction of the physician.

Source page: https://510kreport.com/device/K071607
Methodology: https://510kreport.com/methodology