# 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

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Medical Limited
- Decided: Oct 30, 2020 after 88 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.
1 later device descends from it; 1 cites it directly.
0 of 29 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 7.

## Most influential descendants
- K211318: PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs (2022), 0 descendants of its own

## Indications for use
PICO 7 Single Use Negative Pressure Wound Therapy System 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 7 Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. PICO 7Y Single Use Negative Pressure Wound Therapy System 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 7Y Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. PICO 14 Single Use Negative Pressure Wound Therapy System 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 14 Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. PICO single use negative pressure systems are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as they 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 systems are suitable for use both in a hospital and homecare setting.

Source page: https://510kreport.com/device/K202157
Methodology: https://510kreport.com/methodology