# K180205: AVELLE Negative Pressure Wound Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Convatec Limited
- Decided: Oct 19, 2018 after 268 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.
3 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K190028: UNO 30 (2020), 1 descendant of its own
- K253263: ConvaVAC™ Negative Pressure Wound Therapy System (2026), 0 descendants of its own
- K221891: UNO Negative Pressure Wound Therapy System (2022), 0 descendants of its own

## Indications for use
The Avelle™ NPWT System is indicated for use on patients that would benefit from a Negative Pressure Wound Therapy (NPWT) device as it may promote wound healing via removal of exudate and infectious materials from low to moderately exuding wound, such as: • Chronic Wounds e.g. Leg ulcers • Acute Wounds • Subacute and dehisced wounds • Traumatic wounds • Flaps & Grafts • Surgically closed incision sites Avelle™ NPWT System is suitable for use in a hospital, post-acute and home health environment.

Source page: https://510kreport.com/device/K180205
Methodology: https://510kreport.com/methodology