# K100823: Wound Pro Apex

- Pathway: 510(k) (Traditional)
- Applicant: Accuro Medical Products, LLC
- Decided: Jan 24, 2011 after 306 days
- Product code: OMP (Negative Pressure Wound Therapy Powered Suction Pump)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K945062 (1995). 13 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080357: Medela Invia Wound Therapy, Medela AG (2008) Summary page 1.
- K061367: Bluesky Vista Wound Vacuum System, Model 100.0500, Blue Sky Medical Group Incorporated (2006) Summary page 1.

## Most influential descendants
- K132225: Extricare (2014), 8 descendants of its own
- K140634: extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing Kit (2014), 4 descendants of its own
- K162159: VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing (2017), 3 descendants of its own
- K241023: Negative Pressure Wound Therapy Device (V-Move, V-Grand) (2024), 0 descendants of its own
- K221223: extriCARE® 3000 Negative Wound Pressure Therapy System (2023), 0 descendants of its own

## Recalls of this device
- Aug 31, 2012 · Class II · Z-0009-2013: Accuro has received reports of some Apex Pumps either failing to operate or malfunctioning, at times without notifying the user of such failure or malfunction on the unit's display screen.

## Indications for use
The WoundPro Apex Negative Pressure Wound Therapy System may promote wound healing, through the drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts may benefit from the use of this device. The WoundPro Apex is intended for use in a healthcare facility only. Types of Wounds Indicated are: Diabetic/Neuropathic ulcers Pressure ulcers Chronic wounds Acute wounds Dehisced wounds

Source page: https://510kreport.com/device/K100823
Methodology: https://510kreport.com/methodology