# K211318: PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs

- Pathway: 510(k) (Traditional)
- Applicant: Smith Nephew Medical Limited
- Decided: Jan 5, 2022 after 250 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: 13 generations back to K945062 (1995). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Smith & Nephew Medical Limited (2020) Summary page 4.

## Indications for use
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System and PICO Fluid Management Packs are 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) o Venous Leg Ulcers — PICO can be used in combination with Graduated Compression Therapy in the management of Venous Leg Ulcers » Flaps and grafts * Closed surgical incisions PICO 7 Single Use Negative Pressure Wound Therapy Systems, PICO 14 Single Use Negative Pressure Wound Therapy Systems and PICO Fluid Management Packs are suitable for use in both a hospital and homecare setting.

Source page: https://510kreport.com/device/K211318
Methodology: https://510kreport.com/methodology