FloSure Ventilation Patch

Q: What is the product code of K150459?

The FDA product code is OMP – Negative Pressure Wound Therapy Powered Suction Pump, a Class II (moderate risk) device regulated under 21 CFR 878.4780.

FDA 510(k) K150459 · Simex Medizintechnik GmbH

Substantially Equivalent

510(k) numberK150459

Submission

Device name: FloSure Ventilation Patch
Applicant: Simex Medizintechnik GmbH
Deisslingen, DE
Received: February 23, 2015
Decision date: January 5, 2016
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OMP – Negative Pressure Wound Therapy Powered Suction Pump
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.4780
Specialty: General, Plastic Surgery

For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

Other 510(k)s with product code OMP

510(k)	Device	Applicant	Decision
K261338	RENASYS DYNAFLOW Kit (66807741)OMP · Traditional	Smith & Nephew Medical, Ltd.	09/11/2026SE
K253263	ConvaVAC Negative Pressure Wound Therapy SystemOMP · Traditional	Convatec Limited, Gdc Building	06/24/2026SE
K253199	Curasys 2 (EMDN0003)OMP · Traditional	CG Bio Co., Ltd.	06/23/2026SE
K260646	Renasys Edge (66803126)OMP · Traditional	Smith & Nephew Medical, Ltd.	05/27/2026SE
K261291	Nisus NPWT Canister 500-mL (CPC-500)OMP · Special	Cork Medical	05/21/2026SE
K254019	Wound Geni NPWT SystemOMP · Traditional	Bechtel Medical, Inc.	05/04/2026SE
K253429	Genadyne ASTRA NPWTOMP · Traditional	Genadyne Biotechnologies, Inc.	03/12/2026SE
K250586	Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam…OMP · Traditional	Deroyal Industries, Inc.	11/21/2025SE
K251646	extriCARE® 1000 Negative Pressure Wound Therapy SystemOMP · Traditional	Alleva Medical Devices	10/03/2025SE
K251826	RENASYS WOUND+ Dressing Kit with AIRLOCK TechnologyOMP · Traditional	Smith & Nephew Medical, Ltd.	09/11/2025SE

More from Smith & Nephew Medical, Ltd.

510(k)	Device	Decision
K141255	Simex Subglottic Aspiration SystemBTA · Traditional	09/22/2014SE
K113291	Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: SIM-EX200 and…OMP · Traditional	08/30/2012SE

Questions and answers

When was FloSure Ventilation Patch cleared by the FDA?

FloSure Ventilation Patch (K150459) received a 510(k) decision of Substantially Equivalent on January 5, 2016, 316 days after the submission was received.

What is the product code of K150459?

The FDA product code is OMP – Negative Pressure Wound Therapy Powered Suction Pump, a Class II (moderate risk) device regulated under 21 CFR 878.4780.