# K920677: Clearsite Hydrogel Wound Dressing Modification

- Pathway: 510(k) (Traditional)
- Applicant: New Dimensions IN Medicine, Inc.
- Decided: Apr 21, 1992 after 67 days
- Product code: NAE (Dressing, Wound, Hydrogel Without Drug And/Or Biologic)
- Device class: 1
- Regulation: 21 CFR 878.4022
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K963293: Augustine Medical Wound Care System Model 68XXX (1997), 1 descendant of its own
- K020077: Modification to Augustine Medical Wound Care System, Model 68XXX (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K920677
Methodology: https://510kreport.com/methodology