# K002859: SSW-Sterile Solution Warmer

- Pathway: 510(k) (Traditional)
- Applicant: Kmi Kolster Methods, Inc.
- Decided: Nov 16, 2000 after 64 days
- Product code: LHC (Warmer, Irrigation Solution)
- Device class: 1
- Regulation: 21 CFR 890.5950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The K.M.L. SSW Sterile Solution Warmer is intended for the administration of sterile solutions at a controlled temperature drawn from containers using K.M.L DIK system administration set. The “K” pump is also used in conjunction with this device.

Source page: https://510kreport.com/device/K002859
Methodology: https://510kreport.com/methodology