# K220560: Dermatac Drape

- Pathway: 510(k) (Traditional)
- Applicant: 3M
- Decided: Jul 14, 2022 after 136 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: 5 generations back to K100821 (2010). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200390: V.A.C. DERMATAC Drape, Kci USA, Inc. (2020) Summary page 5.

## Indications for use
The Dermatacm Drape is an accessory to the following V.A.C.@ Therapy Negative Pressure Wound Therapy Systems: * 3MTM ActiV.A.C.TM, 3MIm V.A.C.@ Simplicity, and 3Mrm V.A.C.ViaTm Negative Pressure Wound Therapy Systems, which are integrated wound management systems for use in acute, extended and home care settings. * The V.A.C.ULTATM and V.A.C.RX4Tm Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional. When used on open wounds, these systems are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention, by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness bums, ulcers (such as diabetic, pressure or venous insufficiency) flaps and grafts. When used on closed surgical incisions, they are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. The Dermatacm Drape is also an accessory to the V.A.C. VERAFLOm Therapy (Instillation) provided by the V.A.C.ULTATM Therapy Unit. V.A.C. VERAFLOm Therapy is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. V.A.C. VERAFLOrm Therapy is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness bums, ulcers (such as diabetic, pressure or venous insufficiency) flaps and grafts.

Source page: https://510kreport.com/device/K220560
Methodology: https://510kreport.com/methodology