# K052626: Smartsuction Harmony Device

- Pathway: 510(k) (Traditional)
- Applicant: Haemonetics Corp.
- Decided: Oct 5, 2005 after 12 days
- Product code: BTA (Pump, Portable, Aspiration (Manual Or Powered))
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K021368 (2002). 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)
- K021368: Medela Basic 30 and Dominant 50 Suction Pumps, Models 037, 057, Medela AG (2002) Summary page 1.

## Most influential descendants
- K062801: Smartsuction Solo Device (2006), 0 descendants of its own

## Recalls of this device
- Jul 28, 2006 · Not classified · Z-0035-2007: Faulty circuit board may short circuit and cause electric shock to operator

## Indications for use
The SmartSuction HARMONY device is an AC-powered suction device intended to be used as a suction source to replace wall suction in the hospital operating room to remove fluids and debris from the surgical field during surgical procedures. The SmartSuction HARMONY device is not intended for endotracheal suction. The SmartSuction HARMONY device automatically adjusts suction up to 150 mmHg negative pressure when the suction tip is occluded. Do not use SmartSuction HARMONY device as a suction source in any procedure where 150 mmHg of suction could damage underlying tissue.

Source page: https://510kreport.com/device/K052626
Methodology: https://510kreport.com/methodology