# K070457: Sun Scientific LLC-Leg Compressor and Pfab

- Pathway: 510(k) (Traditional)
- Applicant: Sun Scientific, LLC
- Decided: May 16, 2007 after 89 days
- Product code: MHW (Dressing, Compression)
- Device class: 1
- Regulation: 21 CFR 880.5075
- 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 K810338 (1981). 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)
- K883224: Unna Boot Dressing W/Calamine, Graham-Field, Inc. (1989) Summary page 2.
- K903532: Unna-Sleeve (TM), Aci Medical, Inc. (1990) Summary page 2.
- K973260: Hydrasorb Sterile Dressing, Avitar, Inc. (1997) Summary page 2.
- K041659: C-BOOT, C-Boot, Ltd. (2004) Summary page 2.
- (no number) Unna Flex Elastic Unna Boot by Convatec: named in the summary without a submission number

## Indications for use
To assist in the management of venous stasis ulcers by applying pressure.

Source page: https://510kreport.com/device/K070457
Methodology: https://510kreport.com/methodology