# K141847: Avance Foam Dressing Kits

- Pathway: 510(k) (Traditional)
- Applicant: Molnlycke Health Care Us, LLC
- Decided: Mar 26, 2015 after 260 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). 12 ancestors in all.
14 later devices descend from it; 5 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122132: Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium, Large) Avance Transparent Film Avance Foam, Molnlycke Health Care (2013) Summary page 5.
- K984371: Mepitel Non Adherent Silicone Dressing, Molnlycke Health Care, Inc. (1999) Summary page 5.

## Most influential descendants
- K170088: Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film (2017), 8 descendants of its own
- K172145: Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 days, Invia Motion – 60 days, Invia Motion – 30 days, Invia Motion – 15 days, Invia Motion – 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad (2018), 3 descendants of its own
- K182409: Applied Tissue Technologies PWD™ Platform Wound Dressing (2019), 2 descendants of its own
- K151872: Avance Y-Connector S (2015), 2 descendants of its own
- K191460: PWD Platform Wound Dressing 3” x 5” Oblong (2019), 1 descendant of its own

## Indications for use
The Avance® NPWT system, with associated products are indicated for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.

Source page: https://510kreport.com/device/K141847
Methodology: https://510kreport.com/methodology