# K050524: EZ-IV Medical Pad Warming Unit, Model 1000

- Pathway: 510(k) (Traditional)
- Applicant: Marda Medical, Inc.
- Decided: Sep 14, 2005 after 196 days
- Product code: IRQ (Unit, Heating, Powered)
- 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. The FDA summary names its predicate without a number.
- (no number) Thermalator. Models T-4-S, T-8-S, etc: named in the summary without a submission number

## Indications for use
The EZ-IV Medical Pad Warming Unit is intended to warm alcohol and povidone iodine skin cleansing pads for use in gaining venous access during intravenous fluid and / or medication administration and to facilitate phlebotomy procedures.

Source page: https://510kreport.com/device/K050524
Methodology: https://510kreport.com/methodology