# K112127: Pico Single Use Negative Pressure Wound Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: May 16, 2012 after 296 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: 7 generations back to K945062 (1995). 22 ancestors in all.
25 later devices descend from it; 3 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080275: NPD 1000 Negative Pressure Wound Therapy System, Iasis Medical, Inc. (2008) Summary page 1.
- K083375: Renasys GO Negative Pressure Wound Therapy, Smith & Nephew, Inc. (2009) Summary page 1.
- K111170: PICO, Smith & Nephew, Inc. (2011). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K151436: PICO Single Use Negative Pressure Wound Therapy System (2016), 23 descendants of its own
- K163387: PICO Single Use Negative Pressure Wound Therapy System (2017), 11 descendants of its own
- 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
- K161599: UNO Negative Pressure Wound Therapy System (2017), 4 descendants 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. Examples of 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/K112127
Methodology: https://510kreport.com/methodology