Cabinet, Ethylene-Oxide Gas Aerator
The Ethylene-Oxide Gas Aerator Cabinet is a device used in healthcare facilities to remove residual ethylene oxide gas from sterilized items before they are safe for patient use or handling. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FLI, regulated under 21 CFR 880.6100 in the General Hospital specialty. This device is eligible for third-party review.
Research product code FLI in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- FLI
- Device Class
- FDA class 2
- Regulation Number
- 880.6100
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K904921 | STERI-VAC(TM) AERATOR MODEL XL | Dec 05, 1990 | Substantially Equivalent | 3M Health Care, Ltd. |
| K902906 | GAS-VAK(R) COMBINATION STERILIZER & VENTILATOR | Oct 15, 1990 | Substantially Equivalent | Gas-Vak |
| K831595 | CASTLE MODEL 3341 & 3441 & 4141 GAS AER | Jun 15, 1983 | Substantially Equivalent | Castle Co. |
| K830165 | BEAR JET 150 VENTILATOR | Apr 12, 1983 | Substantially Equivalent | Bear Medical Systems, Inc. |
| K813201 | CASTLE #3241 GAS AERATOR | Dec 31, 1981 | Substantially Equivalent | Sybron Corp. |
| K790677 | EO EVACUATING SYSTEM I | May 07, 1979 | Substantially Equivalent | Castle Co. |
| K781484 | CASTLE MODEL 3146 GAS AERATOR | Oct 27, 1978 | Substantially Equivalent | Castle Co. |
| K761341 | PORTAGAS AERATOR | Feb 28, 1977 | Substantially Equivalent | Amsco Co. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.