# K140634: extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing Kit

- Pathway: 510(k) (Traditional)
- Applicant: Devon Medical, Inc.
- Decided: Sep 19, 2014 after 191 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: 8 generations back to K945062 (1995). 26 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110078: Extricare, Devon Medical Products, Inc. (2012) Summary page 4.
- K132225: Extricare, Devon Medical, Inc. (2014). Cleared while this submission was under review Summary page 4.
- K082211: Renasys-F Negative Pressure Wound Therapy Foam Dressing Kits, Smith & Nephew, Inc. (2008) Summary page 4.
- K092992: A4-XLR8 Foam Dressing, Genadyne Biotechnologies, Inc. (2010) Summary page 4.

## Most influential descendants
- K162159: VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing (2017), 3 descendants of its own
- K211571: Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit (2022), 0 descendants of its own
- K202823: Innomed NPWT Silicone Foam Dressing (2021), 0 descendants of its own
- K182458: Longterm NPWT Foam Dressing Kit (2019), 0 descendants of its own

## Indications for use
The extriCARE® NPWT foam kit is intended to be used in conjunction with the extriCARE® 2400 NPWT pump. The extriCARE® 2400 Negative Pressure Wound Therapy System is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudate, infectious materials, and tissue debris from the wound bed. The extriCARE 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/K140634
Methodology: https://510kreport.com/methodology