# K902401: Celsite (TM) Implantable Drug Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Burron Medical, Inc.
- Decided: Oct 8, 1991 after 496 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 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
- K952435: Celsite Pediatric Venous System (1996), 3 descendants of its own
- K110424: Dignity Mini Port- Attachable; Dignity Mini Port- Pre Attached; Dignity Low Profile Port- Attachable; Dignity Low Profil (2011), 1 descendant of its own
- K061424: Celsite/ Celsite Concept, Access Ports (2006), 1 descendant of its own
- K130576: Celsite Implantable Access Port Systems (2013), 0 descendants of its own
- K121383: PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components) (2012), 0 descendants of its own

Source page: https://510kreport.com/device/K902401
Methodology: https://510kreport.com/methodology