# K060046: Dermastream

- Pathway: 510(k) (Traditional)
- Applicant: Enzysurge, Ltd.
- Decided: Feb 27, 2006 after 52 days
- Product code: NAD (Dressing, Wound, Occlusive)
- Device class: 1
- Regulation: 21 CFR 878.4020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K811291 (1981). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020781: Wet Chamber, Kinetic Concepts, Inc. (2002) Summary page 1.
- K973036: 3M Tegaderm Transparent Dressing, 3M Tegaderm Transparent Dressing (First Aid Delivery), 3M Tegaderm HP Transparent Dres, 3M Healthcare (1997) Summary page 1.
- K901845: Tegaderm Brand Transparent Dressing Series 16XX, 3M Company (1990) Summary page 1.
- K021501: V.a.C. Instillamat (Vacuum Assisted Closure Instillamat, Kinetic Concepts, Inc. (2002) Summary page 1.

## Most influential descendants
- K091133: Aplion Topical Care System (2009), 0 descendants of its own

## Indications for use
The DermaStream Tm is an occlusive wound dressing which permits the introduction of topical wound treatments such as irrigating solutions, antimicrobial and enzymatic debriding solutions, suspensions, and other solutions. It is intended to provide a moist healing environment and allow debridement to facilitate the normal wound healing process.

Source page: https://510kreport.com/device/K060046
Methodology: https://510kreport.com/methodology