# K994111: Celsite, Models ST401L, ST405L

- Pathway: 510(k) (Special)
- Applicant: B. Braun/Mcgaw
- Decided: Jan 3, 2000 after 28 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- 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
- K130576: Celsite Implantable Access Port Systems (2013), 0 descendants of its own

## Indications for use
The Celsite® System is recommended for use whenever patient therapy requires repeated I.V. Access for injection, drug therapy and/or blood sampling.

Source page: https://510kreport.com/device/K994111
Methodology: https://510kreport.com/methodology