# K220660: Prevena Restor Adapti-Form Dressing

- Pathway: 510(k) (Traditional)
- Applicant: 3M Healthcare Business Group
- Decided: Jul 1, 2022 after 116 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: 10 generations back to K945062 (1995). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181507: PREVENA RESTOR (TM) Incision Management System, Kci USA, Inc. (2019) Summary page 4.

## Indications for use
The Prevena™ Restor™ Adapti-Form™ Dressing is part of the Prevena™ Restor™ Incision Management System and is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.

Source page: https://510kreport.com/device/K220660
Methodology: https://510kreport.com/methodology