# K983680: Trinity II Single Chamber DVT Pump

- Pathway: 510(k) (Traditional)
- Applicant: Delphi Consulting Group
- Decided: Apr 28, 1999 after 190 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 K881632 (1988). 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)
- K881632: Flowtron DVT System AC500 Pump, L501 Garment, Huntleigh Technology, Inc. (1988) Summary page 2.
- K954489: Trinity Sleeve (S), Delphi Consulting Group (1996) Summary page 4.

## Indications for use
The Trinity Il Single Chamber DVT System Pump (with sleeves), is designed to reduce pooling of blood, increase venous biood flow in the lower extremities of the recumbent patient to reduce deep vein thrombosis and pulmonary embolism. The intended patient population is adult with the environment of use being hospital, clinic.

Source page: https://510kreport.com/device/K983680
Methodology: https://510kreport.com/methodology