# K180614: PICO Single Use Negative Pressure Wound Therapy System

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew Medical Limited
- Decided: Apr 6, 2018 after 29 days
- Product code: OMP (Negative Pressure Wound Therapy Powered Suction Pump)
- 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: 10 generations back to K945062 (1995). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172521: PICO Single Use Negative Pressure Wound Therapy System, Smith & Nephew Medical Limited (2017) Summary page 5.

## Indications for use
PICO is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. Appropriate wound types include: -Chronic -Acute -Traumatic - Subacute and dehisced wounds -Partial-thickness burns -Ulcers (such as diabetic or pressure) -Flaps and grafts - Closed surgical incisions PICO Single Use Negative Pressure Wound Therapy System is suitable for use both in a hospital and homecare setting.

Source page: https://510kreport.com/device/K180614
Methodology: https://510kreport.com/methodology