# K992032: Acry Island Border Dressing, Models 2031, 2032, 2033

- Pathway: 510(k) (Traditional)
- Applicant: Acrymed, Inc.
- Decided: Aug 19, 1999 after 64 days
- Product code: KMF (Bandage, Liquid)
- Device class: 1
- Regulation: 21 CFR 880.5090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) AcryDerm® Advanced Wound Dressing: named in the summary without a submission number
- (no number) Clearsite™ Bordered Dressing: named in the summary without a submission number
- (no number) Uni-Site™ Breathable Transparent Dressing: named in the summary without a submission number

## Indications for use
Cover dressing for the following wounds: Over the Counter uses include: Lacerations Minor buriis Skin tears Abrasions Use prescribed by a healthcare professional include: Pressure sores Diabetic ulcers Incision wounds Donor site wounds Venous stasis ulcers Arterial stasis ulcers

Source page: https://510kreport.com/device/K992032
Methodology: https://510kreport.com/methodology