# K991437: Wells Johnson Infusion System, Model 20-6000-00

- Pathway: 510(k) (Traditional)
- Applicant: Wells Johnson Co.
- Decided: Aug 30, 1999 after 126 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.
7 later devices descend from it; 2 cite it directly.
0 of 8 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
- K040149: Psi-Tec Peristaltic Infiltration Pump (2004), 6 descendants of its own
- K092066: Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01), Phaser Waste Collection Kit (Was-01), Phaser Cannulae (2010), 2 descendants of its own
- K121218: Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4MM Dia, 26 CM Length, 3 Aperture Reusable Cannula, 4MM Dia, (2012), 1 descendant of its own
- K130152: Hydrasolve Lipoplasty System (2013), 0 descendants of its own
- K101413: Euromi Eva SP6 (2010), 0 descendants of its own

## Indications for use
Indications for use are: General surgical fluid irrigation and infiltration.

Source page: https://510kreport.com/device/K991437
Methodology: https://510kreport.com/methodology