# K143362: extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister

- Pathway: 510(k) (Special)
- Applicant: Devon Medical Products
- Decided: Feb 3, 2015 after 71 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The extriCARE® 3600 Negative Pressure Wound Therapy 1000cc canister is intended to be used in conjunction with extriCARE® 3600 Negative Pressure Wound Therapy (NPWT) Systems, adding to the original canister selections. The extriCARE® 3600 Negative Pressure Wound Therapy System is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudates, infectious materials, and tissue debris from the wound bed. The extriCARE® 3600 Negative Pressure Wound Therapy System is indicated for the following wound types: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

Source page: https://510kreport.com/device/K143362
Methodology: https://510kreport.com/methodology