# K062644: Flexwarmer, Models KZ-1 and KZ-2

- Pathway: 510(k) (Traditional)
- Applicant: Merlyn Associates, Inc.
- Decided: Sep 11, 2007 after 370 days
- Product code: LGZ (Warmer, Thermal, Infusion Fluid)
- 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.
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 portable infusion warmer, FLEXWARMER KZ-1 and KZ-2 is dry warmer which supplies extemal heat to the plastic tubing incorporated administration sets for intermittent use and low flow rate application at 1 to 8 mL/min. The KZ-1 and KZ-2 is available in two sizes: 4mm and 5mm channels for administration sets.

Source page: https://510kreport.com/device/K062644
Methodology: https://510kreport.com/methodology