# K191760: PICO 14 Single Use Negative Pressure Wound Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Medical Limited
- Decided: Dec 5, 2019 after 157 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: 12 generations back to K945062 (1995). 27 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180698: PICO 7 Single Use Negative Pressure Wound Therapy System, Smith & Nephew Medical Limited (2018) Summary page 4.

## Most influential descendants
- K213906: extriCARE 1000 Negative Pressure Wound Therapy System (2023), 1 descendant of its own
- K251646: extriCARE® 1000 Negative Pressure Wound Therapy System (2025), 0 descendants of its own

## Indications for use
PICO 14 is indicated for patients who would benefit from a suction device (NPWT) as it may promote would 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 14 Single Use Negative Pressure Wound Therapy System is suitable for use both in a hospital and homecare setting.

Source page: https://510kreport.com/device/K191760
Methodology: https://510kreport.com/methodology