# K954489: Trinity Sleeve (S)

- Pathway: 510(k) (Traditional)
- Applicant: Delphi Consulting Group
- Decided: Feb 22, 1996 after 148 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
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K983680: Trinity II Single Chamber DVT Pump (1999), 0 descendants of its own
- K963957: Trinity DVT System (1997), 0 descendants of its own
- K970014: Trinity Sleeves, Huntleigh Pump Compatible (T.B.D.) (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K954489
Methodology: https://510kreport.com/methodology