# K121361: Curaline Polyurethane Foam Awc Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Curaline, Inc.
- Decided: Nov 30, 2012 after 207 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K871166 (1987). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K880330: Ferris Hydrophilic Dressing, Ferris Mfg. Corp. (1988) Summary page 1.
- K900127: Ferris Hydrophilic Dressing (Add'l Indications), Ferris Mfg. Corp. (1990) Summary page 1.
- K932913: Ferris Polymem Hydrophilic Wound Dressing, Ferris Mfg. Corp. (1994) Summary page 1.
- K963096: Allevyn Hydro Poly Dressing ND All Trac Dressing, Smith & Nephew United, Inc. (1996) Summary page 1.
- K871166: Allevyn Hydrophilic Polyurethane Dressing, Smith & Nephew, Inc. (1987) Summary page 1.
- K983184: Mepilex, Molnlycke Health Care, Inc. (1998)

## Indications for use
Curaline Polyurethane Foam Dressing is indicated for use in the management of: * Partial and full thickness wounds * Pressure ulcers (Stage I-fl') * Diabetic ulcers * Acute and chronic venous stasis ulcers * Arterial ulcers * Skin grafts; donor and recipient sites * Burns (1st and 2nd degree) * Skin tears and avulsions * Abrasions * Surgical wounds * Tube, catheter, drain and I.V. sites * Dermatologic disorders * Under compression bandages/wraps * Traumatic wounds * Acute and Chronic woonds * Minimal, moderate and heavily exuding wounds

Source page: https://510kreport.com/device/K121361
Methodology: https://510kreport.com/methodology