# K014013: H & W Hospital Ethylene Oxide Sterilizer Control System

- Pathway: 510(k) (Abbreviated)
- Applicant: H & W Technology, LLC
- Decided: Jun 25, 2003 after 567 days
- Product code: FLF (Sterilizer, Ethylene-Oxide Gas)
- Device class: 2
- Regulation: 21 CFR 880.6860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K901146 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901146: Joslyn EO Sterilizer/ EO Modernization Kit, Joslyn Valve Corp. (1991) Summary page 1.

## Indications for use
The H & W Hospital Ethylene Oxide Sterilizer Control System is an accessory in the form of an electronic control system for the retrofit of existing sterilizers to provide operator and information monitoring capabilities of a personal computer (PC) together with the functional reliability, safety, and dependability of control obtained through the use of a programmable logic controller (PLC). The H & W Hospital Ethylene Oxide Sterilizer Control System is intended to retrofit existing Steris (Amsco) Eagle Model 2000 & 3000 series and Getinge (Castle) Model M/C 3500, 3600 or 4200 series Hospital EO Sterilizers only. The automated cycle performs in such a manner as to assure the repeatability of the process. The predetermined cycles duplicate the cycles provided by the original equipment manufacturer and are demonstrated to deliver the biological performance as stipulated in the consensus standard ANSI/AAMI ST-24.

Source page: https://510kreport.com/device/K014013
Methodology: https://510kreport.com/methodology