# K150459: FloSure Ventilation Patch

- Pathway: 510(k) (Traditional)
- Applicant: Simex Medizintechnik GmbH
- Decided: Jan 5, 2016 after 316 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: 7 generations back to K945062 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133333: Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing Kit, Blue Ocean Medical Product, LLC (2014) Summary page 4.

## Indications for use
The FloSure Ventilation Patch is intended to be used in conjunction with NPWT Dressing Kits compatible with the SIMEX NPWT Systems EX200 and EX300 for the application of negative pressure wound therapy to the wound. The FloSure Ventilation Patch is to be applied to the occlusive wound dressing. When used in conjunction with the Simex NPWT EX200 and EX300 pumps and dressing kits, the FloSure Ventilation Patch is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of wound exudates, infectious material and tissue debris. The FloSure Ventilation Patch is appropriate for use on the following wounds: • Pressure Ulcers • Diabetic/Neuropathic Ulcers • Venous Insufficiency Ulcers • Traumatic Wounds • Post-Operative and Dehisced Surgical Wounds • Skin Flap and Grafts

Source page: https://510kreport.com/device/K150459
Methodology: https://510kreport.com/methodology