# K896422: Burron Ambulatory Drug Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Burron Medical, Inc.
- Decided: May 9, 1990 after 182 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
49 later devices descend from it; 8 cite it directly.
2 of 50 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
- K980558: Painbuster Infusion System (1998), 47 descendants of its own
- K982946: Painbuster Infusion Kit (1998), 42 descendants of its own
- K984502: Nerve Block Infusion Kit (1999), 33 descendants of its own
- K020862: I-Flow Elastomeric Pump (2002), 19 descendants of its own
- K023098: Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit (2002), 17 descendants of its own

Source page: https://510kreport.com/device/K896422
Methodology: https://510kreport.com/methodology