# K071735: Modification to Disposable Infusion Pump Kit

- Pathway: 510(k) (Special)
- Applicant: Symbios Medical Products, LLC
- Decided: Jul 19, 2007 after 23 days
- Product code: MEB (Pump, Infusion, Elastomeric)
- 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
Longest line of descent: 1 generation back to K051474 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051474: Symbios Disposable Infusion Pump Kit, Symbios Medical Products, LLC (2005) Summary page 2.
- (no number) Catheter Needle/Introducer: named in the summary without a submission number

## Indications for use
The Disposable Infusion Pump is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a preset rate for post-operative pain management.

Source page: https://510kreport.com/device/K071735
Methodology: https://510kreport.com/methodology