# K052650: Pioneer U601 Series Aspirator

- Pathway: 510(k) (Abbreviated)
- Applicant: Merits Health Products Co., Ltd.
- Decided: Nov 4, 2005 after 39 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) THOMAS INDUSTRIES MEDI Pump Aspirator Model 1135: named in the summary without a submission number

## Most influential descendants
- K071607: ASA01 Heavy Duty Suction Pump (2007), 0 descendants of its own

## Indications for use
The Merits Pioneer U601 Series Aspirator is to be used to remove bodily fluids from the patients' airway or respiratory support system. It is for use on the order of a physician only

Source page: https://510kreport.com/device/K052650
Methodology: https://510kreport.com/methodology