# K991214: Simplicare Transparent Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Hollister, Inc.
- Decided: Oct 14, 1999 after 188 days
- Product code: MGP (Dressing, Wound And Burn, Occlusive)
- 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: 2 generations back to K811291 (1981). 3 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923235: Bioclusive MVP Transparent Dressing, Johnson & Johnson Medical, Inc. (1993) Summary page 1.
- K961319: Epiview, Convatec, A Division of E.R. Squibb & Sons (1996) Summary page 1.

## Most influential descendants
- K020781: Wet Chamber (2002), 3 descendants of its own
- K060046: Dermastream (2006), 1 descendant of its own
- K091133: Aplion Topical Care System (2009), 0 descendants of its own
- K043063: Oxyband Wound Dressing (2005), 0 descendants of its own

## Indications for use
The SimpliCare Transparent Wound Dressing is intended to provide a moist wound healing environment to facilitate the normal wound healing process. The SimpliCare Transparent Wound Dressing provides a barrier to viral and bacterial contaminants and other external contaminates such as urine and feces. The SimpliCare Wound Dressing is also intended to be used on IV sites or as secondary fixation device for products such as alginates, gels and foam dressings. The SimpliCare Transparent Wound Dressing is indicated for use on wounds including: * minor burns and scalds * superficial cuts, lacerations and abrasions * minor irritations of the skin This wound dressing may also be used for non-exudating to minimally exudating partial and full thickness wounds such as: ¢ pressure ulcers e lacerations/abrasions » surgical incisions « second degree burns ¢ donor sites In addition, the SimpliCare Transparent Wound Dressing can be used on IV sites and as a secondary fixation device

Source page: https://510kreport.com/device/K991214
Methodology: https://510kreport.com/methodology