# K002596: Gebauer's Fluro Ethyl, Model 0386-0002-09

- Pathway: 510(k) (Traditional)
- Applicant: Gebauer Co.
- Decided: Feb 15, 2001 after 178 days
- Product code: MLY (Vapocoolant Device)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Sep 3, 2008 · Not classified · Z-0218-2009: Some units of Fluro-Ethyl containing the defective valve which could malfunction and spray refrigerant out from the side of the valve in addition to or instead of spraying in the normal inverted posit

Source page: https://510kreport.com/device/K002596
Methodology: https://510kreport.com/methodology