# K020538: Boehringer Laboratories Pneumatic Ambulatory Compression System 8200 Series

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Laboratories
- Decided: May 15, 2002 after 85 days
- Product code: DWL (Stocking, Medical Support (To Prevent Pooling Of Blood In Legs))
- Device class: 2
- Regulation: 21 CFR 880.5780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

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

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K022233: Hydroboot (2002), 0 descendants of its own

## Indications for use
The Boehringer Laboratories, Inc. Pneumatic Ambulatory Compression System (PACS™) is indicated for the application of controlled pressure to the lower extremities in order to prevent blood pooling in the lower leg. Pooling of blood in the legs is associated with: venous insufficiency, edema, lymphedema, active venous ulcers, healed venous ulcers, pronounced varicosities and post-thrombotic syndrome. The PACS™ is to be used on the order of a Physician.

Source page: https://510kreport.com/device/K020538
Methodology: https://510kreport.com/methodology