# K163387: PICO Single Use Negative Pressure Wound Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Medical Limited
- Decided: Apr 18, 2017 after 137 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: 9 generations back to K945062 (1995). 24 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112127: Pico Single Use Negative Pressure Wound Therapy System, Smith & Nephew, Inc. (2012) Summary page 4.
- K151436: PICO Single Use Negative Pressure Wound Therapy System, Smith & Nephew Medical, Ltd. (2016) Summary page 5.

## Most influential descendants
- K172005: PICO 7 Single Use Negative Pressure Wound Therapy System (2018), 8 descendants of its own
- K180698: PICO 7 Single Use Negative Pressure Wound Therapy System (2018), 6 descendants of its own
- K191760: PICO 14 Single Use Negative Pressure Wound Therapy System (2019), 2 descendants of its own
- K213906: extriCARE 1000 Negative Pressure Wound Therapy System (2023), 1 descendant of its own
- K202157: PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack (2020), 1 descendant of its own

## 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/K163387
Methodology: https://510kreport.com/methodology