# K062801: Smartsuction Solo Device

- Pathway: 510(k) (Traditional)
- Applicant: Haemonetics Corp.
- Decided: Oct 4, 2006 after 15 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: 2 generations back to K021368 (2002). 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)
- K052626: Smartsuction Harmony Device, Haemonetics Corp. (2005) Summary page 1.

## Indications for use
The SmartSuction Solo device is an AC-powered, stand-alone device designed to be used as a suction source to replace wall suction in the operating room to remove fluids and debris from the surgical field during surgical procedures. The SmartSuction Solo device is intended for use by trained personnel under the direction of the physician. The SmartSuction Solo device is not intended for endotracheal suction. The SmartSuction Solo device automatically adjusts suction up to 150 mmHg negative pressure when the suction tip is occluded. Do not use SmartSuction Solo device as a suction source in any procedure where 150 mmHg of suction could damage underlying tissue. This device is intended for use by trained personnel under the direction of a physician. The attending physician is responsible for the proper use of these devices. Therefore, the device is to be used as a prescription medical device, which is indicated in the labeling as "Rx only".

Source page: https://510kreport.com/device/K062801
Methodology: https://510kreport.com/methodology