# K991203: Irrigation or Infusion Pump K Pump

- Pathway: 510(k) (Traditional)
- Applicant: Kmi Kolster Methods, Inc.
- Decided: Oct 15, 1999 after 190 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.
28 later devices descend from it; 2 cite it directly.
2 of 29 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
- K071328: Visualase Thermal Therapy System (2007), 26 descendants of its own
- K081509: Monteris Medical Autolitt Laser Probe (2009), 22 descendants of its own
- K120561: Neuroblate System (2013), 21 descendants of its own
- K131955: Neuroblate (TM) System (2013), 19 descendants of its own
- K131278: Monteris Medical Neuroblate System (2013), 19 descendants of its own

## Indications for use
The KM I Irrigation or Infusion pump “K” Pump is intended for the administration of sterile solutions drawn from containers using standard sterile administration sets with a 3/8 diameter silicone peristaltic section. The “K” Pump is intended for the rapid introduction of sterile fluids into the wound site for wound irrigation. The “K” pump may also be used with K.M.L.’s DIK Irrigation System.

Source page: https://510kreport.com/device/K991203
Methodology: https://510kreport.com/methodology