# K963957: Trinity DVT System

- Pathway: 510(k) (Traditional)
- Applicant: Delphi Consulting Group
- Decided: Nov 4, 1997 after 398 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910188 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954489: Trinity Sleeve (S), Delphi Consulting Group (1996) Summary page 1.
- K910188: Flowplus AC330 Pump Garments, Huntleigh Technology, Inc. (1991) Summary page 1.

## Indications for use
The Trinity DVT System is designed to reduce pooling of blood, increase venous blood flow in the lower extremities of the recumbent patient to reduce deep vein thrombosis and pulmonary embolism.

Source page: https://510kreport.com/device/K963957
Methodology: https://510kreport.com/methodology