# K082211: Renasys-F Negative Pressure Wound Therapy Foam Dressing Kits

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Nov 14, 2008 after 100 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). 7 ancestors in all.
68 later devices descend from it; 5 cite it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061919: Versatile 1 Ezcare Wound Vacuum System, Blue Sky Medical Group Incorporated (2007) Summary page 1.
- K070904: Antlia II Suction Pump System, Innovative Therapies, Inc. (2007) Summary page 1.

## Most influential descendants
- K110647: Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT Wound Dressing Kits with Suction Pad; Renasys (2011), 48 descendants of its own
- K092992: A4-XLR8 Foam Dressing (2010), 31 descendants of its own
- K122132: Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium, Large) Avance Transparent Film Avance Foam (2013), 21 descendants of its own
- K141847: Avance Foam Dressing Kits (2015), 14 descendants of its own
- K142979: RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX Canisters (2015), 12 descendants of its own

## Recalls of this device
- Dec 14, 2010 · Not classified · Z-0875-2012: On 12/14/2010, Smith & Nephew, Inc. Wound Management Division in St. Petersburg, FL recalled their RENASYS PORT product code number 66800694 due to small holes in the primary pouch of some of the pack

## Indications for use
RenasysTM -F NPWT Foam Dressing Kits are intended to be used In conjunction with Smith & Nephew Negative Pressure Wound Therapy (NPWT) systems to deliver negative pressure to the wound. Smith & Nephew NPWT systems are indicated for patients who would benefit from a suction device partIcularly as the device may promote wound healing. NPWT is appropriate for use on the following wounds: • Pressure ulcers • Diabetic/neuropathic ulcers • Venous insufficiency ulcers • Traumatic wounds • Post-operative and dehisced surgical wounds • Explored fistulas • Skin flaps and grafts

Source page: https://510kreport.com/device/K082211
Methodology: https://510kreport.com/methodology