FLI · Cabinet, Ethylene-Oxide Gas Aerator
General Hospital · 21 CFR 880.6100 · Class 2
Overview
| Product Code | FLI |
|---|---|
| Device Name | Cabinet, Ethylene-Oxide Gas Aerator |
| Regulation | 21 CFR 880.6100 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
An ethyene oxide gas aerator cabinet is a device that is intended for use by a health care provider and consists of a cabinet with a ventilation system designed to circulate and exchange the air in the cabinet to shorten the time required to remove residual ethylene oxide (ETO) from wrapped medical devices that have undergone ETO sterilization. The device may include a heater to warm the circulating air.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K904921 | STERI-VAC(TM) AERATOR MODEL XL | 3M Health Care, Ltd. | Dec 5, 1990 | SESE |
| K902906 | GAS-VAK(R) COMBINATION STERILIZER & VENTILATOR | Gas-Vak | Oct 15, 1990 | SESE |
| K831595 | CASTLE MODEL 3341 & 3441 & 4141 GAS AER | Castle Co. | Jun 15, 1983 | SESE |
| K830165 | BEAR JET 150 VENTILATOR | Bear Medical Systems, Inc. | Apr 12, 1983 | SESE |
| K813201 | CASTLE #3241 GAS AERATOR | Sybron Corp. | Dec 31, 1981 | SESE |
| K790677 | EO EVACUATING SYSTEM I | Castle Co. | May 7, 1979 | SESE |
| K781484 | CASTLE MODEL 3146 GAS AERATOR | Castle Co. | Oct 27, 1978 | SESE |
| K761341 | PORTAGAS AERATOR | Amsco Co. | Feb 28, 1977 | SESE |
Top Applicants
- Castle Co. — 3 clearances
- 3M Health Care, Ltd. — 1 clearance
- Amsco Co. — 1 clearance
- Bear Medical Systems, Inc. — 1 clearance
- Gas-Vak — 1 clearance
