# K974393: Vaso Press System

- Pathway: 510(k) (Traditional)
- Applicant: Britt Corp., Inc.
- Decided: Mar 19, 1999 after 483 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Apr 8, 2019 · Class II · Z-1343-2019: Product design change did not receive proper premarket clearance and lacks a 510 (k)
- Apr 8, 2019 · Class II · Z-1347-2019: Product design change did not receive proper premarket clearance and lacks a 510 (k)
- Apr 8, 2019 · Class II · Z-1345-2019: Product design change did not receive proper premarket clearance and lacks a 510 (k)
- Apr 8, 2019 · Class II · Z-1346-2019: Product design change did not receive proper premarket clearance and lacks a 510 (k)
- Apr 8, 2019 · Class II · Z-1348-2019: Product design change did not receive proper premarket clearance and lacks a 510 (k)
- Apr 8, 2019 · Class II · Z-1344-2019: Product design change did not receive proper premarket clearance and lacks a 510 (k)

## Indications for use
Treatment of lymphatic and venous disorders.

Source page: https://510kreport.com/device/K974393
Methodology: https://510kreport.com/methodology